Study of Satraplatin (JM-216) in Combination With Docetaxel

Study Overview
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Brief Summary
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This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria. PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors. WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Official Title
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Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies

Conditions
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Tumors

Intervention / Treatment
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* Drug: satraplatin and docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective Life expectancy of at least 3 months Measurable or evaluable disease ECOG performance status of <= 2 Willingness and ability to give informed consent Exclusion Criteria: Women who are pregnant or breastfeeding Other chemotherapy treatment less than 4 weeks prior to enrollment Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: satraplatin and docetaxel|Satraplatin - oral administration within 2 hours of docetaxel infusion. Subsequent dosing will be on days 2-5 at approximate 24 hour intervals. Docetaxel will be administered as intravenous infusion over 1 hour followed by saline flush.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose and Safety |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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satraplatin, docetaxel, cancer, Phase I, advanced solid tumors