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
  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:


Further study details as provided by CASI Pharmaceuticals, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Indiana
IUPUI
Indianapolis, Indiana, United States
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
  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 CASI Pharmaceuticals, Inc.:
Advanced and Metastatic Breast Cancer

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

ClinicalTrials.gov processed this record on October 30, 2014