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

This study has been completed.
Sponsor:
Information provided by:
CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00306631
First received: March 22, 2006
Last updated: June 2, 2009
Last verified: June 2009

March 22, 2006
June 2, 2009
January 2006
April 2008   (final data collection date for primary outcome measure)
Antitumor activity, based on the objective response rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00306631 on ClinicalTrials.gov Archive Site
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A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: MKC-1
Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle
Experimental: 1
Intervention: Drug: MKC-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
November 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00306631
MKC-101
Yes
Carolyn Sidor, Chief Medical Officer, Miikana Therapeutics, an EntreMed Company
CASI Pharmaceuticals, Inc.
Not Provided
Not Provided
CASI Pharmaceuticals, Inc.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP