Status:
COMPLETED
A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1
Lead Sponsor:
CASI Pharmaceuticals, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 metas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00306631
Start Date
January 1 2006
End Date
November 1 2008
Last Update
June 3 2009
Active Locations (1)
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1
IUPUI
Indianapolis, Indiana, United States