Breast Cancer
Conditions
Keywords
Advanced and Metastatic Breast Cancer
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.
Interventions
DRUGMKC-1
Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle
Sponsors
CASI Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antitumor activity, based on the objective response rate | every 8 weeks |
Countries
United States
Outcome results
None listed