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

Study Overview
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Brief Summary
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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

Official Title
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A Phase Ib, Multicenter, Open-label, Dose-finding Study of Patupilone Administered Intravenously Every 3 Weeks in Combination With Carboplatin AUC 6 in Adult Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: Patupilone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patupilone only<br>Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin | Drug: Patupilone<br> <br> |
| Active Comparator: Carboplatin alone<br>Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin | Drug: Patupilone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6) |  | Every 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations |  | Every 6 weeks | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, maximum tolerated dose, dose-limiting toxicity, patupilone, carboplatin, pharmacokinetics