Phase 1 Study of MKC-1 in Patients With Advanced Cancer

Study Overview
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Brief Summary
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This is an open-label study to determine the highest dose of MKC-1 that may be administered daily on a continuous basis for patients with advanced or refractory solid tumors.

Official Title
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Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: MKC-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. Age greater than or equal to 18 years. ECOG performance status ≤1 ANC greater than or equal to 1,500/mm3; Platelets greater than or equal to 100,000/mm3 creatinine ≤1.5 times institutional upper limit of normal (ULN) T Bili within normal limits; AST and ALT less than or equal to 2.5 times ULN; and albumin greater than or equal to 3.0 g/dL have measurable disease by RECIST, radiographically evaluable disease, or detectable disease women of child-bearing potential and men must agree to use adequate contraception Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Have previously received MKC-1. Have received radiation to greater than 25% of the bone marrow. Have had anti-cancer therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Are concurrently receiving any other investigational agents while on study. Have known brain metastases Have any condition that impairs the ability to swallow and retain MKC-1 capsules. Uncontrolled intercurrent illness Are pregnant or breastfeeding HIV-positive patients Patients with uncontrolled diabetes

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: 1<br> | Drug: MKC-1<br>* 30 mg and 100 mg capsules, dosed BID daily on a continuous schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors. |  | Throughout study participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine evidence of benefit in cancer patients when MKC-1 is administered orally twice a day (bid) continuously by evaluating tumor response and/or tumor marker improvement. |  | During study participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced cancer