Clinical trial · Interventional
Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors
Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors
NCT01407562CI-TRIAL-00061094terminatedPhase 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)
This is an open label, dose escalation study to determine the safety and tolerability and maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer - Female | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor - Protocol Specific | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pazopanib with paclitaxel and carboplatin
- interventionNames
- Drug: Pazopanib
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle
- timeFrame
- 4 years, 6 months
- description
- Toxicity will be assessed every 28 days up to 30 days after the last dose of treatment. Dose limiting toxicity is defined as 1. Non-hematological toxicity ≥ grade 3 (excluding alopecia, nausea, vomiting, or diarrhea for which adequate supportive therapy has not been instituted). 2. Hematologic toxicity: * Grade 4 neutropenia lasting ≥ 7 days * Grade 4 neutropenia and fever of ≥ 38.5°C * ≥ Grade 3 neutropenia with ≥ Grade 3 infection * Grade 4 thrombocytopenia * Inability to start next cycle of treatment by more than 4 weeks due to unresolved toxicity
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of a solid malignancy with advanced disease that has relapsed, that is refractory to standard therapies, or for which there is not standard therapy, or for which the patient opts not to receive standard therapy. * At the recommended phase II dose level, triple-negative breast cancer defined as ER-negative, PR-negative, and HER2-negative, will be enrolled and another 10 patients with a solid malignancy who would benefit from a paclitaxel and carboplatin-based regimen, will also be enrolled. * Male or female ≥ 18 years of age * Able to swallow and retain oral medications Exclusion Criteria: * Major surgery within last 28 days or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within last 21 days. Patients who have completed therapy with mitomycin C or nitrosurea will have to wait 42 days. * More than 3 prior lines of cytotoxic chemotherapy for metastatic disease
References
Publications (0)
Data not yet available
No reference posted for this study.