Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT00426582

Run by

Novartis Pharmaceuticals

People needed

48

Starts

2006-08-01

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Norwalk Hospital — Norwalk, Connecticut, United States
• Associates in Oncology — Rockville, Maryland, United States
• Wertz Clinical Cancer Center (Wayne State University) — Detroit, Michigan, United States
• Siteman Cancer Center (Washington University School of Medicine) — St Louis, Missouri, United States
• Cancer Research and Treatment Center (University of New Mexico) — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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