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

NCT ID: NCT00306631

Last Updated: 2009-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-11-30

Brief Summary

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

MKC-1

Intervention Type: DRUG

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

Interventions

MKC-1

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CASI Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Miikana Therapeutics, an EntreMed Company

Locations

IUPUI

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

MKC-101

Identifier Type: -

Identifier Source: org_study_id