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

NCT00306631 | Completed Phase 2 DMC

• 1 other identifier: MKC-101
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

Advanced and Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Antitumor activity, based on the objective response rate

  every 8 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: MKC-1

Interventions

MKC-1 DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the breast
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (1)

IUPUI

Indianapolis, Indiana, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 22, 2006
• First Posted: March 24, 2006
• Study Start: January 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 3, 2009

Record last verified: 2009-06

Locations

US (1)