Clinical trial · Interventional
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors
A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in Combination With Pazopanib in Subjects With Advanced Solid Tumors
NCT00732420CI-TRIAL-00030326completedPhase 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)
To determined what dose of topotecan can be safely given with daily pazopanib.
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 |
|---|---|---|---|
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm A
- description
- Daily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose.
- interventionNames
- Drug: topotecan
- Drug: pazopanib
- type
- EXPERIMENTAL
- label
- Treatment Arm B
- description
- Daily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose.
- interventionNames
- Drug: topotecan
- Drug: pazopanib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria - * signed, written informed consent. * at least 18 years of age. * ECOG performance status 0 or 1. * Subjects must have histologically or cytologically confirmed diagnosis of advanced cancer and a solid tumor malignancy that has relapsed or is refractory to standard therapy or for which there is no established therapy. * able to swallow and retain oral medications. * females are eligible to enter and participate in this study providing adequate established contraception is being practiced. Exclusion Criteria * had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) * received an investigational drug within 30 days or 5 half-lives (whichever is longer). * received prior treatment with pazopanib/investigational anti-angiogenic compounds. * presence of uncontrolled infection. * pregnant or lactating. * poorly controlled hypertension (SBP of ? 140 mmHg, or DBP of ? 90 mmHg. * Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.- * arterial thrombi, myocardial infarction, admission for unstable angina, uncontrolled or symptomatic arrhythmia, cardiac angioplasty, or stenting within the last 6 months. * any unresolved bowel obstruction or diarrhea ? Grade 1. * received an allogeneic bone marrow transplant. * known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or topotecan. * any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study. * psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. * clinical history, current alcohol or illicit drug use which, in the judgment of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
References
Publications (0)
Data not yet available
No reference posted for this study.