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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306631
• Other study ID #: MKC-101
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2006
• Last updated: June 2, 2009
• Start date: January 2006
• Est. completion date: November 2008

Study information

• Verified date: June 2009
• Source: CASI Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• MKC-1
Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle

Locations

Country	Name	City	State
United States	IUPUI	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
CASI Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor activity, based on the objective response rate		every 8 weeks	No