A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1

Study Overview
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Brief Summary
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This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. The study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following MKC-1 therapy.

Official Title
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A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Advanced or Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: MKC-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the breast 18 years or older Karnofsky performance status greater than or equal to 70% Radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Must have failed both a taxane and an anthracycline, given sequentially or in combination, either in an adjuvant or metastatic setting All acute toxicity of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade less than or equal to 1 Lab results, within 10 days of MKC-1 administration: Hemoglobin less than or equal to 9 g/dL Absolute neutrophil count greater than or equal to 1.5 x 10^9/L Platelet count greater than or equal to 75 x 10^9/L Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal) AST less than or equal to 2.5 x ULN Serum albumin greater than or equal to LLN (lower limit of normal) Total bilirubin less than or equal to ULN Alkaline phosphatase less than or equal to 2.5 x ULN Signed informed consent Exclusion Criteria: Pre-existing hepatomegaly with disease measures greater than or equal to 2 cm below the costal margin, secondary to malignancy Administration of cancer specific therapy within the following periods prior to study drug initiation: chemotherapy less than 3 weeks prior hormonal therapy less than one week prior radiation therapy less than 2 weeks prior Be pregnant or lactating; not employing effective birth control Known central nervous system (CNS) metastases unless treated, clinically stable and not requiring steroids Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy Administration of any investigational agent (therapeutic or diagnostic) within 4 weeks prior to receipt of study medication Uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL) Serious cardiac condition Any medical conditions that, in the investigator's opinion would impose excessive risk to the patient Patients with previous malignancies unless free of recurrence for at least 5 years except basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix Treatment with antiretroviral therapy metabolized through CYP3A4

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>* Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor activity, based on the objective response rate |  | every 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced and Metastatic Breast Cancer