Status:
COMPLETED
Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 s...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, or for whom no standard therapy exists, or who might benefit from treatment with carboplatin
- A minimum of 4 weeks since the last treatment with chemotherapy
- WHO Performance Status 0 (able to carry out all normal activity without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work)
- Age ≥ 18
- Adequate hematological parameters
- No major impairment of renal or hepatic function
- Written informed consent obtained
- Exclusion criteria:
- Major surgery less than 4 weeks prior to study entry and/or not fully recovered from surgery
- Chemotherapy or investigational compound less than 4 weeks prior to study entry, or planned while participating in the study
- Prior administration of an epothilone
- Hypersensitivity to carboplatin. Patients resistant to carboplatin are not recommended to enter the trial
- Radiotherapy (RT) less than 4 weeks prior to study entry (except for palliative therapy of distant metastases), or planned RT while participating in the study
- Diarrhea within 7 days prior to start of treatment. Unresolved bowel obstruction
- Peripheral neuropathy \> Grade 1 (mild)
- Symptomatic brain metastases
- Colostomy
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00426582
Start Date
August 1 2006
Last Update
December 9 2020
Active Locations (5)
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1
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
2
Associates in Oncology
Rockville, Maryland, United States, 20850
3
Wertz Clinical Cancer Center (Wayne State University)
Detroit, Michigan, United States, 48201
4
Siteman Cancer Center (Washington University School of Medicine)
St Louis, Missouri, United States, 63110-1093