Hycamtin

(topotecan hydrochloride)

Phase 3Small molecule

Topotecan is used to treat certain types of cancer, including ovarian cancer, lung cancer, and cervical cancer. It works by stopping cancer cells from dividing and growing.[1] Hycamtin is currently being investigated across 8 indications[3], with its most advanced program in Phase 3.[1]

Hycamtin is one of 141 small molecule programs targeting Acute Myeloid Leukemia. It is currently in Phase 3.

Indications

144

Total Trials

Active Trials

140

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Acute Myeloid LeukemiaCompleted

Small Cell CarcinomaUnknown

RetinoblastomaActive, not recruiting

Extensive Stage Lung Small Cell CarcinomaActive, not recruiting

Fallopian Tube Clear Cell AdenocarcinomaActive, not recruiting

Metastatic Malignant Solid NeoplasmActive, not recruiting

GanglioneuroblastomaRecruiting

Small Cell Lung CancerCompleted

Acute Myeloid LeukemiaPhase 2

Completed

Small Cell CarcinomaPreclinical

Unknown

RetinoblastomaPreclinical

Active, not recruiting

Extensive Stage Lung Small Cell CarcinomaPhase 2

Active, not recruiting

Fallopian Tube Clear Cell AdenocarcinomaPreclinical

Active, not recruiting

Metastatic Malignant Solid NeoplasmPreclinical

Active, not recruiting

GanglioneuroblastomaPhase 3

Recruiting

Small Cell Lung CancerPhase 3

Completed

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

59 2

Novantrone

Pfizer

Phase 3

34 3

Xospata

Astellas

Phase 3

24 4

Fludara

Sanofi

Phase 3

17 5

Vepesid

AAvyxa

Phase 3

52 6

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 7

Vanflyta

Daiichi Sankyo

Phase 3

14 8

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 9

Cellcept

Trexall

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Acute Myeloid Leukemia

NCT03289910

Q1 2027

Phase 1Active, not recruiting

Metastatic Lung Small Cell Carcinoma

NCT04514497

PreclinicalActive, not recruiting

Fallopian Tube Clear Cell Adenocarcinoma

NCT02502266

PreclinicalActive, not recruiting

Metastatic Malignant Solid Neoplasm

NCT01012817

Phase 1Active, not recruiting

Small Cell Lung Cancer

NCT05353439

Q2 2027

Phase 2Active, not recruiting

Extensive Stage Lung Small Cell Carcinoma

NCT03896503

Clinical

Trials by Indication[1]

Small Cell Lung Cancer20 trials

Testing of Tazemetostat in Combination With Topotecan and Pembrolizumab in Patients With Recurrent Small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05353439·18 enrolled

Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00033696·65 enrolled

Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Withdrawn·—·Phase 2·NCT00006374

Show 17 more trials

Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00003281·84 enrolled

Topotecan Hydrochloride or Cyclodextrin-Based Polymer-Camptothecin CRLX101 in Treating Patients With Recurrent Small Cell Lung Cancer

Terminated·UUniversity of Chicago·Phase 2·NCT01803269·29 enrolled

S9914: Combination Chemotherapy Plus Filgrastim in Untreated Extensive-Stage Small Cell Lung Cancer

Completed·SSWOG Cancer Research Network·Phase 2·NCT00004137·88 enrolled

Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Completed·—·Phase 3·NCT00041015·4 enrolled

Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00028925·27 enrolled

Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00521144·22 enrolled

Topotecan, Paclitaxel, and Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00004055·38 enrolled

Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00003812·75 enrolled

7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00098956·19 enrolled

Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 1/2·NCT00006012·73 enrolled

Topotecan Hydrochloride and Doxorubicin Hydrochloride in Treating Relapsed or Refractory Small Cell Lung Cancer

Completed·UUniversity of Nebraska·Phase 1·NCT00856037·22 enrolled

Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Completed·WWake Forest University Health Sciences·Phase 2·NCT00025272·14 enrolled

S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00828139·189 enrolled

Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01533181·44 enrolled

Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer

Completed·UUniversity of Alabama at Birmingham·Phase 1/2·NCT00004186·55 enrolled

Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

Terminated·—·Phase 2·NCT00087048·1 enrolled

Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

Completed·—·Phase 3·NCT00003917·4 enrolled

Neuroblastoma12 trials

Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma

Unknown status·GGerman Society for Pediatric Oncology and Hematology GPOH gGmbH·Phase 3·NCT00410631·642 enrolled

Topotecan, Vincristine, and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma

Unknown status·CChildren's Cancer and Leukaemia Group·Phase 2·NCT00392340·63 enrolled

High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma

Withdrawn·CChildren's Cancer and Leukaemia Group·Phase 2·NCT00389766

Show 9 more trials

Multiple Therapies in Treating Patients With Advanced Neuroblastoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00040872

Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Completed·CChildren's Oncology Group·Phase 1·NCT01798004·150 enrolled

Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma

Completed·CCentre Oscar Lambret·Phase 2·NCT00960739·30 enrolled

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

Completed·CChildren's Oncology Group·Phase 3·NCT00567567·665 enrolled

Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

Completed·CChildren's Oncology Group·Phase 1·NCT01175356·99 enrolled

Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

Unknown status·GGerman Society for Pediatric Oncology and Hematology GPOH gGmbH·N/A·NCT00526318·360 enrolled

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

Completed·CChildren's Oncology Group·Phase 3·NCT00004188·495 enrolled

Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma

Completed·CChildren's Oncology Group·Phase 1·NCT00070200·31 enrolled

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma

Completed·CChildren's Oncology Group·Phase 3·NCT00499616·464 enrolled

Fallopian Tube Cancer10 trials

UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Completed·UUniversity Health Network, Toronto·Phase 2·NCT00072267

Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00028743·819 enrolled

Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Completed·MMayo Clinic·Phase 2·NCT02312245·13 enrolled

Show 7 more trials

Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT02569957·1 enrolled

ZD9331 With or Without Topotecan in Treating Patients With Refractory or Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00014690

Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer

Completed·GGynecologic Oncology Group·Phase 1·NCT00003967·24 enrolled

Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer

Terminated·GGynecologic Oncology Group·Phase 1·NCT00003382

Combination Chemotherapy and Autologous Peripheral Stem Cell Transplant in Treating Patients With Stage III, Stage IV, or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Completed·—·Phase 1·NCT00550784·8 enrolled

Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Completed·NNYU Langone Health·Phase 1·NCT00006391

UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

Completed·UUniversity Health Network, Toronto·Phase 1·NCT00045175·33 enrolled

Ovarian Cancer9 trials

Sequential Chemotherapy in Treating Patients With Residual Disease Following Surgery for Stage IIB, Stage III, or Stage IV Ovarian Cancer

Unknown status· GSK logo

GSK·Phase 2·NCT00003733·40 enrolled

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer

Unknown status·HHerbert Irving Comprehensive Cancer Center·Phase 1/2·NCT00003064·30 enrolled

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer

Terminated·GGynecologic Oncology Group·Phase 2·NCT00004221·12 enrolled

Show 6 more trials

Radiolabeled Monoclonal Antibody, Paclitaxel, and Interferon Alfa in Treating Patients With Recurrent Ovarian Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00002734·30 enrolled

Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT05295589

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Cancer

Completed·GGeorgetown University·Phase 1/2·NCT00003297·50 enrolled

Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer

Completed·RRigshospitalet, Denmark·Phase 2·NCT00003732·80 enrolled

Topotecan, High-Dose Cyclophosphamide, Carboplatin, and an Autologous Peripheral Blood Cell Transplant in Treating Patients With Recurrent Ovarian Cancer or Primary Peritoneal Cancer

Completed·MMayo Clinic·Phase 1·NCT00652691·48 enrolled

Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00002913·30 enrolled

Cervical Cancer7 trials

Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer

Completed·GGynecologic Oncology Group·Phase 2·NCT00087126·27 enrolled

Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01266447·27 enrolled

Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer

Completed·AARCAGY/ GINECO GROUP·Phase 1/2·NCT00807079·12 enrolled

Show 4 more trials

Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

Completed·GGynecologic Oncology Group·Phase 2·NCT00276796·66 enrolled

Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

Completed·GGynecologic Oncology Group·Phase 3·NCT00003945·400 enrolled

Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00803062·452 enrolled

Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer

Completed·MMasonic Cancer Center, University of Minnesota·Phase 1·NCT00287911·18 enrolled

52 more indications

Primary Peritoneal Cancer5 trials

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

Completed·GGynecologic Oncology Group·Phase 1·NCT00005026

Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Completed·—·Phase 1·NCT00055614·20 enrolled

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Completed·FFox Chase Cancer Center·Phase 2·NCT00003944·3 enrolled

Show 2 more trials

Topotecan in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

Terminated·GGynecologic Oncology Group·Phase 2·NCT00005029

Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Completed·GGynecologic Oncology Group·Phase 2·NCT00114166·81 enrolled

Myelodysplastic Syndrome5 trials

Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

Unknown status·AALZA·Phase 2·NCT00003827·25 enrolled

Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed/Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome

Completed·—·Phase 1·NCT00005593·31 enrolled

Amifostine Plus Topotecan in Treating Patients With Myelodysplastic Syndrome

Completed·UUniversity of Arizona·Phase 1/2·NCT00003415·26 enrolled

Show 2 more trials

Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia

Completed·—·Phase 1/2·NCT00003619

Topotecan in Treating Patients With Myelodysplastic Syndrome

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00003675·100 enrolled

Leukemia5 trials

Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00005962

Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00003255·38 enrolled

Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia

Completed·—·Phase 1·NCT00002588·30 enrolled

Show 2 more trials

Topotecan in Treating Children With Refractory Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00002705·3 enrolled

Cyclophosphamide Plus Topotecan in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00003340

Lymphoma5 trials

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00006125

Combination Chemotherapy With or Without Biological Therapy in Treating Patients With Refractory Solid Tumor or Lymphoma

Completed·FFox Chase Cancer Center·Phase 1·NCT00005021·17 enrolled

Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

Withdrawn·TThe Methodist Hospital Research Institute·N/A·NCT00109798

Show 2 more trials

Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT00006373·27 enrolled

Topotecan and Radiation Therapy in Treating Patients With Solid Tumors or Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00002625·5 enrolled

Ewing sarcoma4 trials

Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT01231906·642 enrolled

Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors

Completed·CChildren's Oncology Group·N/A·NCT00618813·35 enrolled

Whole-Body Radiation Therapy, Systemic Chemotherapy, and High-Dose Chemotherapy Followed By Stem Cell Rescue in Treating Patients With Poor-Risk Ewing Sarcoma

Withdrawn·—·N/A·NCT01795430

Show 1 more trial

Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide With or Without Bevacizumab in Treating Young Patients With Refractory or First Recurrent Extracranial Ewing Sarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00516295·7 enrolled

Patients With Advanced Solid Tumors3 trials

R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors

Completed·NNYU Langone Health·Phase 1·NCT00005990

Bortezomib and Topotecan in Treating Patients With Advanced Solid Tumors

Completed·UUniversity of California, Davis·Phase 1·NCT00388089·24 enrolled

Bortezomib and Topotecan Hydrochloride in Treating Patients With Advanced Solid Tumors

Completed·—·Phase 1·NCT00541359·54 enrolled

Non-Small Cell Lung Cancer3 trials

Topotecan and Paclitaxel in Treating Patients With Advanced Non-small Cell Lung Cancer or Other Advanced Solid Tumors

Completed·JJonsson Comprehensive Cancer Center·Phase 1/2·NCT00004979

Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00002537·20 enrolled

Topotecan and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Did Not Respond to Previous Systemic Chemotherapy

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00365547·46 enrolled

Malignant Glioma2 trials

Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma

Terminated·RRush University Medical Center·Phase 2·NCT00014443·5 enrolled

Chemotherapy in Treating Patients With Recurrent Malignant Glioma

Completed·—·Phase 1·NCT00002986·36 enrolled

Advanced Cancer2 trials

Combination Chemotherapy in Treating Patients With Advanced Cancer

Completed·NNYU Langone Health·Phase 1·NCT00003331·30 enrolled

Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer

Completed·YYale University·Phase 1/2·NCT00002950·25 enrolled

Chronic Myelogenous Leukemia2 trials

Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia

Completed·MMayo Clinic·Phase 1·NCT00002693

Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

Completed·CChildren's Oncology Group·Phase 2·NCT00003735·11 enrolled

Stage IV Ovarian Epithelial Cancer2 trials

Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer

Completed·AAGO Study Group·Phase 3·NCT00006454

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Completed·GGynecologic Oncology Group·Phase 3·NCT00011986·4,312 enrolled

Stem Cell Transplantation2 trials

High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer

Terminated·YYale University·Phase 1·NCT00002948

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer.

Completed·FFox Chase Cancer Center·Phase 2·NCT00003943·3 enrolled

Bone Marrow Transplantation2 trials

Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT00004006·4 enrolled

Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00002515

Primary Peritoneal Cavity Cancer2 trials

Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 1·NCT00287859·5 enrolled

Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00217555

Ovarian Epithelial Cancer2 trials

Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

Completed·NNYU Langone Health·Phase 2·NCT00005051

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT00005612·3 enrolled

Acute Myeloid Leukemia2 trials

Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00634244·92 enrolled

NCI 10147: A Phase II Randomized Study of Topotecan/Carboplatin With or Without Veliparib in Advanced Myeloproliferative Disorders and Chronic Myelomonocytic Leukemia (CMML)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03289910·25 enrolled

Recurrent or Refractory2 trials

Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00003745·125 enrolled

Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus

Terminated·GGynecologic Oncology Group·Phase 2·NCT00003156

Rhabdomyosarcoma2 trials

Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT00003958·702 enrolled

Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

Unknown status·EEuropean Paediatric Soft Tissue Sarcoma Study Group·Phase 3·NCT00379457·600 enrolled

Breast Cancer1 trial

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT00006032

Patients With Solid Tumors1 trial

Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00002587·20 enrolled

Bone Sarcoma1 trial

Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas

Completed·NNorthwestern University·Phase 2·NCT02357810·178 enrolled

Treatment1 trial

Topotecan Hydrochloride in Treating Children With Meningeal Cancer That Has Not Responded to Previous Treatment

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00005811·77 enrolled

Myeloproliferative Disorder1 trial

Veliparib and Topotecan With or Without Carboplatin in Treating Patients With Relapsed or Refractory Acute Leukemia, High-Risk Myelodysplasia, or Aggressive Myeloproliferative Disorders

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00588991·12 enrolled

Advanced Malignancies1 trial

A Dose Finding Phase I Trial of the Combination of Topotecan and PS-341, a Novel Proteasome Inhibitor, in Advanced Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00068484·25 enrolled

Prostate Cancer1 trial

Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer

Withdrawn·FFox Chase Cancer Center·Phase 2·NCT00084565

Recurrent or Refractory Solid Tumors1 trial

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors

Terminated·SSeattle Children's Hospital·Phase 1·NCT00003194·24 enrolled

Chemotherapy1 trial

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

Completed·GGynecologic Oncology Group·Phase 3·NCT00064077·513 enrolled

Refractory Solid Tumors1 trial

Ifosfamide and Topotecan in Treating Patients With Refractory Solid Tumors

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00003198

Retinoblastoma1 trial

Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma

Withdrawn·—·N/A·NCT00980551

Brain Cancer1 trial

Combination Chemotherapy for Patients With Brain Cancer

Completed·—·Phase 2·NCT00002814·20 enrolled

Refractory Cancer1 trial

Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain

Completed·NNYU Langone Health·Phase 1·NCT00025311

Anaplastic Large Cell Lymphoma1 trial

Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

Completed·CChildren's Oncology Group·Phase 1·NCT01606878·46 enrolled

Primitive Neuroectodermal Tumor1 trial

Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00002643·130 enrolled

Stem Cell Transplant1 trial

Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Relapsed Solid Tumor

Completed·—·Phase 1·NCT00638898·25 enrolled

Newly Diagnosed1 trial

Combination Chemotherapy With or Without Topotecan in Treating Patients With Newly Diagnosed Localized Ewing's Sarcoma

Withdrawn·CChildren's Oncology Group·Phase 3·NCT00334867

Spinal Cord Tumor1 trial

Tamoxifen, Carboplatin, and Topotecan in Treating Patients With CNS Metastases or Recurrent Brain or Spinal Cord Tumors

Completed·—·Phase 2·NCT00541138·50 enrolled

Relapsed/Refractory AML1 trial

Fludarabine/Carboplatin/Topotecan w/Thalidomide for Relapsed/Refractory AML, CML and MDS

Completed·—·Phase 2·NCT00053287·42 enrolled

Peritoneal Cancer1 trial

MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer

Terminated·MMayo Clinic·Phase 2·NCT02364713·17 enrolled

Glioma1 trial

Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma

Terminated·CChildren's Oncology Group·Phase 1/2·NCT00107471·7 enrolled

Recurrent or Metastatic1 trial

Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

Completed·HHerbert Irving Comprehensive Cancer Center·Phase 2·NCT00003065·25 enrolled

Advanced or Metastatic Solid Tumors1 trial

Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01654965·17 enrolled

Lung Cancer1 trial

Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

Completed·MMedical University of South Carolina·Phase 1·NCT00287963·18 enrolled

Gynecologic Cancer1 trial

Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery

Completed·—·Phase 1·NCT00842452·26 enrolled

Meningitis1 trial

Topotecan in Treating Young Patients With Neoplastic Meningitis Due to Leukemia, Lymphoma, or Solid Tumors

Terminated·PPediatric Brain Tumor Consortium·Phase 1·NCT00112619·19 enrolled

Acute Leukemia1 trial

Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Leukemia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00462787·23 enrolled

Brain Tumors1 trial

Topotecan in Treating Patients With Recurrent Brain Tumors

Completed·NNCIC Clinical Trials Group·Phase 2·NCT00003372·17 enrolled

Metastatic Malignant Solid Neoplasm1 trial

A Phase 1/2 Trial of ABT-888, an Inhibitor of Poly(ADP-ribose) Polymerase (PARP), and Topotecan (TPT) in Patients With Solid Tumors (Phase 1) and Relapsed Ovarian Cancer or Primary Peritoneal Cancer (Phase 2) After Prior Platinum Containing First-Line Chemotherapy

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT01012817·88 enrolled

Metastatic Lung Small Cell Carcinoma1 trial

BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients With Advanced Solid Tumors, Phase I Studies With Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA)

Active, not recruiting· Takeda logo

Takeda·Phase 1·NCT04514497·29 enrolled

Ganglioneuroblastoma1 trial

A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

Recruiting·CChildren's Oncology Group·Phase 3·NCT03126916·750 enrolled

Fallopian Tube Mucinous Adenocarcinoma1 trial

A Randomized Phase II Trial of Triplet Therapy (A PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination With Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women With Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04739800·120 enrolled

Extensive Stage Lung Small Cell Carcinoma1 trial

Randomized Phase II Trial of Topotecan Plus M6620 (VX-970, Berzosertib) Vs. Topotecan Alone in Patients With Relapsed Small-Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03896503·104 enrolled

Fallopian Tube Clear Cell Adenocarcinoma1 trial

A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT02502266·582 enrolled

Regulatory

FDA Approval Timeline[4]

May 28, 1996

HYCAMTIN

NDA NDA020671

May 28, 1996

HYCAMTIN

NDA NDA020671

Feb 4, 1998

HYCAMTIN

NDA NDA020671

Nov 30, 1998

HYCAMTIN

NDA NDA020671

Jan 18, 2000

HYCAMTIN

NDA NDA020671

Feb 10, 2000

HYCAMTIN

NDA NDA020671

Aug 3, 2001

HYCAMTIN

NDA NDA020671

Mar 6, 2002

HYCAMTIN

NDA NDA020671

Feb 26, 2003

HYCAMTIN

NDA NDA020671

Mar 11, 2003

HYCAMTIN

NDA NDA020671

May 9, 2003

HYCAMTIN

NDA NDA020671

Jun 14, 2006

HYCAMTIN

NDA NDA020671

Oct 11, 2007

HYCAMTIN

NDA NDA020981

Sep 5, 2008

HYCAMTIN

NDA NDA020981

Mar 26, 2010

HYCAMTIN

NDA NDA020671

Mar 26, 2010

HYCAMTIN

NDA NDA020671

Jun 30, 2010

HYCAMTIN

NDA NDA020981

Feb 2, 2011

TOPOTECAN HYDROCHLORIDE

NDA NDA200582

Feb 25, 2011

TOPOTECAN

NDA NDA200199

Oct 7, 2011

HYCAMTIN

NDA NDA020981

Dec 20, 2012

TOPOTECAN HYDROCHLORIDE

NDA NDA022453

Feb 28, 2014

HYCAMTIN

NDA NDA020671

Jun 18, 2014

HYCAMTIN

NDA NDA020981

Jun 2, 2015

HYCAMTIN

NDA NDA020671

Sep 5, 2018

HYCAMTIN

NDA NDA020981

Sep 5, 2018

HYCAMTIN

NDA NDA020671

Oct 8, 2019

HYCAMTIN

NDA NDA020671

Sources

References

[1]
ClinicalTrials.gov — 144 trial records for topotecan hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — topotecan hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for topotecan hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020671). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Meitheal company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA Topoisomerase I Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: MMeitheal

Hycamtin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Small Cell Lung Cancer20 trials

Neuroblastoma12 trials

Fallopian Tube Cancer10 trials

Ovarian Cancer9 trials

Cervical Cancer7 trials

Primary Peritoneal Cancer5 trials

Myelodysplastic Syndrome5 trials

Leukemia5 trials

Lymphoma5 trials

Ewing sarcoma4 trials

Patients With Advanced Solid Tumors3 trials

Non-Small Cell Lung Cancer3 trials

Malignant Glioma2 trials

Advanced Cancer2 trials

Chronic Myelogenous Leukemia2 trials

Stage IV Ovarian Epithelial Cancer2 trials

Stem Cell Transplantation2 trials

Bone Marrow Transplantation2 trials

Primary Peritoneal Cavity Cancer2 trials

Ovarian Epithelial Cancer2 trials

Acute Myeloid Leukemia2 trials

Recurrent or Refractory2 trials

Rhabdomyosarcoma2 trials

Breast Cancer1 trial

Patients With Solid Tumors1 trial

Bone Sarcoma1 trial

Treatment1 trial

Myeloproliferative Disorder1 trial

Advanced Malignancies1 trial

Prostate Cancer1 trial

Recurrent or Refractory Solid Tumors1 trial

Chemotherapy1 trial

Refractory Solid Tumors1 trial

Retinoblastoma1 trial

Brain Cancer1 trial

Refractory Cancer1 trial

Anaplastic Large Cell Lymphoma1 trial

Primitive Neuroectodermal Tumor1 trial

Stem Cell Transplant1 trial

Newly Diagnosed1 trial

Spinal Cord Tumor1 trial

Relapsed/Refractory AML1 trial

Peritoneal Cancer1 trial

Glioma1 trial

Recurrent or Metastatic1 trial

Advanced or Metastatic Solid Tumors1 trial

Lung Cancer1 trial

Gynecologic Cancer1 trial

Meningitis1 trial

Acute Leukemia1 trial

Brain Tumors1 trial

Metastatic Malignant Solid Neoplasm1 trial

Metastatic Lung Small Cell Carcinoma1 trial

Ganglioneuroblastoma1 trial

Fallopian Tube Mucinous Adenocarcinoma1 trial

Extensive Stage Lung Small Cell Carcinoma1 trial

Fallopian Tube Clear Cell Adenocarcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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