Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors
- Registration Number
- NCT00426582
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Carboplatin alone Patupilone Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin Patupilone only Patupilone Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6) Every 3 weeks
- Secondary Outcome Measures
Name Time Method Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors) Every 6 weeks Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response Every 6 weeks Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations Every 6 weeks Pharmacokinetic profile of patupilone combined with carboplatin First 6 weeks (cycle 1 & 2 only) Relationship between pharmacokinetics and clinical outcome Every 6 weeks during cycle 1 & cycle 2
Trial Locations
- Locations (5)
Wertz Clinical Cancer Center (Wayne State University)
🇺🇸Detroit, Michigan, United States
Cancer Research and Treatment Center (University of New Mexico)
🇺🇸Albuquerque, New Mexico, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Associates in Oncology
🇺🇸Rockville, Maryland, United States
Siteman Cancer Center (Washington University School of Medicine)
🇺🇸Saint Louis, Missouri, United States