Clinical trial · Interventional
A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors
A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors (4C)
NCT00259935CI-TRIAL-00030370completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Small Cell | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All treated subjects
- description
- Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1.
- interventionNames
- Drug: topotecan
Primary outcomes (1)
- measure
- Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2.
- timeFrame
- Days 1, 8
Secondary outcomes (1)
- measure
- Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1
- timeFrame
- Up to 38 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with advanced solid tumors. * At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery. * Subjects must be free of post-treatment side effects. Exclusion Criteria: * Women who are pregnant or lactating * Subjects with uncontrolled emesis, regardless of etiology, active infection.
References
Publications (0)
Data not yet available
No reference posted for this study.