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

This study has been completed.
Sponsor:
Information provided by:
EntreMed
ClinicalTrials.gov Identifier:
NCT00306631
First received: March 22, 2006
Last updated: June 2, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: MKC-1
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EntreMed:

Primary Outcome Measures:
  • Antitumor activity, based on the objective response rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: January 2006
Study Completion Date: November 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306631

Locations
United States, Indiana
IUPUI
Indianapolis, Indiana, United States
Sponsors and Collaborators
EntreMed
  More Information

No publications provided

Responsible Party: Carolyn Sidor, Chief Medical Officer, Miikana Therapeutics, an EntreMed Company
ClinicalTrials.gov Identifier: NCT00306631     History of Changes
Other Study ID Numbers: MKC-101
Study First Received: March 22, 2006
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by EntreMed:
Advanced and Metastatic Breast Cancer

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

ClinicalTrials.gov processed this record on May 16, 2013