Topotecan hydrochloride has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Topotecan hydrochloride studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
104864/032 IV An open label evaluation of topotecan administered intravenously as five daily 30 minute infusions every 21 days to patients with ovarian tumours refractory to other therapies
104864/039 III An Open-Label, Multicenter, Randomized, Phase III Study of Topotecan HCl as Single Agent, Second-Line Therapy (Administered Intravenously as Five Daily Doses Every 21 Days) Versus Taxolâ (Administered as a Three-Hour Infusion Every 21 Days) in Women With Advanced Epithelial Ovarian Carcinoma
104864/067/080 III An Open-Label, Multicenter, Randomized, Phase III, Comparative Study of Topotecan, as Single Agent, Second-Line Therapy Administered Intravenously or Orally as Five Daily Doses Every 21 Days in Women with Advanced Ovarian Cancer
104864/096 III An open-label, multicentre, randomised, phase III study of topotecan plus cisplatin versus paclitaxel plus cisplatin for the first-line treatment of patients with advanced ovarian carcinoma.
104864/396 III An open-label, multicentre, randomised, phase III comparator study of oral topotecan versus intravenous topotecan for second-line therapy in patients with SCLC who have relapsed greater than or equal to 90 days after completion of first-line therapy
104864/A/090 III An Open Label, Multicenter, Randomized, Phase III Study of Hycamtin (Topotecan) as Single Agent, Second-Line Therapy (Administered Intravenously as Five Daily Doses Every 21 Days) Versus Second-Line Cyclophosphamide, Doxorubicin and Vincristine (CAV) in Patients with SCLC Who Have Relapsed At Least 60 Days After Completion of First-Line Therapy.
104864/A201 III A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS
HCT103369 (GOG-0179) III A randomized phase III study of cisplatin versus cisplatin plus topotecan versus methotrexate/vinblastine/doxorubicin/cisplatin (MVAC) in stage IVB, recurrent or persistent carcinoma of the cervix.
SKF-104864/615 III An Open-Label, Multicenter, Randomized, Phase III Study Comparing Combination Intravenous (IV) Topotecan/Docetaxel to Docetaxel Alone in Second-Line Advanced (IIIB/IV) Non-Small-Cell Lung Cancer (NSCLC)
104864/012 II An Open Phase Ii Study To Evaluate The Efficacy And Toxicity Of Topotecan Administered Intravenously As Five Daily Infusions Every 21 Days To Women With Advanced Epithelial Ovarian Carcinoma
104864/014 EORTC II A phase II trial with topotecan 1.5 mg/m2/day for five consecutive days every 21 days in sensitive and refractory subjects with small cell lung cancer (SCLC)
104864/015 II An Open Phase II Study to Evaluate the Efficacy and Toxicity of Topotecan Administered Intravenously as Five Daily Infusions Every 21 Days to Patients with Advanced Non-Small Cell Lung Cancer
104864/033 II An open, multicenter, Phase II study of intravenous topotecan, given as five daily doses every 21 days, in advanced epithelial ovarian cancer to patients who have failed prior chemotherapy containing paclitaxel and cisplatin or carboplatin
104864/034 II An open, multicentre, Phase II study of intravenous topotecan, given as 5 daily doses every 21 days, in advanced epithelial ovarian cancer
104864/051 II An Open, Non-Comparative, Phase II Study of Topotecan Given as a Continuous 21-Day Infusion Every 28 days, to Women with Advanced Epithelial Ovarian Cancer who have failed One Prior Chemotherapy Regimen Containing Cisplatin or Carboplatin
104864/053 II An Open-Label, Multicenter, Non-Comparative Study of Topotecan as Single Agent, Second-Line Therapy (Administered Intravenously as Five Daily Doses Every 21 Days) in Patients with Small Cell Lung Cancer
104864/057 II An Open-Label, Non-Comparative, Phase II Study of Topotecan as Single Agent, First-Line Therapy Administered as a Continuous 21-Day Infusion Every 28 Days to Patients with Stage IIIB and IV Non-Small Cell Lung Cancer.
104864/059 II An Open-label, Non-Comparative, Phase II Study of Topotecan as Single Agent, Second-Line Therapy Administered as a Continuous 21-Day Infusion Every 28 Days to Patients with Relapsed or Refractory Small Cell Lung Cancer
104864/065 II An open-label multicentre, randomised, phase II comparator study of oral topotecan versus intravenous topotecan for second-line therapy in sensitive patients with small cell lung cancer
104864/092 II Phase II trial with topotecan in patients with small cell lung cancer.
104864/094 II EORTC 08957: A phase II trial of Topotecan in combination with Cisplatin as second line treatment in small cell lung cancer (SCLC)
104864/181 II Phase II Study of Topotecan in Patients with Extensive Small Cell Lung Cancer
104864/251 II A phase II study to determine the efficacy and safety of topotecan administered intravenously daily for 5 days with a single intravenous dose of carboplatin on Day 1 repeated every 21 days in patients with advanced non-small cell lung cancer
104864/373 II A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered every 21 Days to Patients with Epithelial Ovarian Cancer Stages IIb, IIc, III and IV
104864/410 II A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer
104864/435 II A Phase II Study of Topotecan and Paclitaxel as First-Line Treatment in Patients with Extensive Disease Small Cell Lung Cancer
104864/557 II A Phase II Trial Of Topotecan and Cisplatin In Patients With Metastatic Or Recurrent Squamous Cell Carcinoma Of The Cervix
104864/627 II An open-label, multicenter, non-comparative, phase II study of the combination of intravenous topotecan and gemcitabine administered once weekly for three weeks every 28 days as second-line treatment in subjects with recurrent platinum-sensitive ovarian cancer
104864/A405 II An Open Label, Multicenter, Randomized, Phase II Study of Topotecan and Paclitaxel vs. Etoposide/Cisplatin as First Line Treatment in Patients with Extensive Disease Small Cell Lung Cancer
104864-A/213 II An Open-label Evaluation of Topotecan Administered Intravenously as Five Daily 30 Minute Infusions every 21 days to Patients with Ovarian Tumors Refractory to Other Therapies.
SK&F104864/111 II An Open, Comparative, Phase II Study of Immediate Versus Delayed Treatment with Topotecan HCl Given as a Continuous 21-Day Infusion Every 28 Days to Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy.
SK&F-104864-623 II An Open Label, Multicenter, Non-Comparative Phase II Study of Weekly Intravenous Vinorelbine and Topotecan in Chemotherapy-Naďve Patients with Advanced Non-Small Cell Lung Cancer
SKF-104864/234 II Phase II Trial of Topotecan Combined With Cisplatin in Persistent or Recurrent Squamous and Non-squamous Cervical Cancer
SKF-104864/612 II A prospective, open label phase II study to evaluate the efficacy and safety of topotecan (Hycamtin) in combination with carboplatin as first-line chemotherapy in patients with ovarian cancer.
104864/005 I Phase I study of topotecan
104864/010 I An Open Phase I Study to Determine the Maximal Tolerated Dose of Topotecan HCl Administered Intravenously as a Single Dose Every 21 Days in Patients with Solid Tumors Refractory to All Known Forms of Effective Therapy
104864/017 I A Phase I Study of Topotecan HCl Administered on a Daily Times Five Schedule with a Single Infusion of Cisplatin every Three Weeks to Patients with Advanced Non-small Cell Lung Carcinoma
104864/178 I A Phase I study to assess the safety and tolerability of Hycamtin administered sequentially to patients with cancer of the ovary who have received carboplatin and Taxol treatment.
104864/A097 I Phase I Study of Topotecan in Cancer Patients with Hepatic or Renal Dysfunction
SK&F104864/100 I A phase I study to determine the maximum tolerated doses of paclitaxel, cisplatin and topotecan (PTC) administered intravenously every 21 days as first line therapy in patients with advanced (stage III and IV) ovarian carcinoma.
SK&F-104864/517 I A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Subjects with Rectal Carcinoma
SKF 104864/191 I Phase I study with Hycamtin® (topotecan) and simultaneous radiation in subjects with non-small cell lung cancer (NSCLC) stage IIIb.