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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306631
Recruitment Status : Completed
First Posted : March 24, 2006
Last Update Posted : June 3, 2009
Information provided by:
CASI Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: MKC-1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. Antitumor activity, based on the objective response rate [ Time Frame: every 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306631

United States, Indiana
Indianapolis, Indiana, United States
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.

Responsible Party: Carolyn Sidor, Chief Medical Officer, Miikana Therapeutics, an EntreMed Company Identifier: NCT00306631     History of Changes
Other Study ID Numbers: MKC-101
First Posted: March 24, 2006    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by CASI Pharmaceuticals, Inc.:
Advanced and Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases