Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments

Study Overview
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Brief Summary
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The purpose of this study is to see how safe the study drug is and to determine the best dose to use in cancer patients in the future. The study drug is designed to reduce the activity of a protein known as heat shock protein 90, or Hsp90. Hsp90 is found in every cell in the human body and normally helps those cells (and the body) cope with stressful situations. In certain cancers, however, Hsp90 helps the cancer cells survive and grow. By reducing the activity of Hsp90, the study drug may slow the growth, and reduce the survival, of those cancer cells.

Detailed Description
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This is a dose escalation study. As subjects participating in the study tolerate a specific dose level, the new subjects entering will be given a higher dose of the study drug.

Official Title
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Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer

Conditions
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Cancer

Intervention / Treatment
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* Drug: MPC-3100 (an Hsp90 inhibitor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: recurrent cancer refractory to available systemic therapy 18 years old or older predicted life expectancy equal or greater to 8 weeks at least 4 weeks post chemotherapy, immunotherapy, surgery, or radiation therapy and have recovered from treatment toxicities Karnofsky Performance Status equal or greater to 60 or ECOG equal or less than 2 adequate organ function based on hematological, liver, and renal function LVEF greater than the lower limit of normal for the institution, as measured by MUGA or by echocardiography wash-out period before first dose os study drug if a protocol prohibited medication is being discontinued Exclusion Criteria: pregnant or breastfeeding received any other anti-cancer treatment or investigational therapy within 28 days prior to Cycle 1 Day 1 symptoms of heart failure equal or greater to Class III (by NYHA criteria) impaired cardiac function or clinically significant cardiac diseases concurrent treatment with medications that either markedly induce or inhibit CYP3A4 concurrent treatment with medications that have a relative risk of prolonging the QT interval or inducing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to study drug

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MPC-3100 (an Hsp90 inhibitor)|oral daily dose for 21 days in a 28-day cycle|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability (Maximum Tolerated Dose) |  | After each cohort is enrolled . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Drug Pharmacokinetics |  | Cycle 1 | 
| Evidence of anti-tumor activity of study drug. |  | After each odd cycle and end of study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral drug, MPC-3100, HSP90 inhibitor, cancer