Phase 1 Study of MKC-1 in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by:
EntreMed
ClinicalTrials.gov Identifier:
NCT00656461
First received: April 7, 2008
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

This is an open-label study to determine the highest dose of MKC-1 that may be administered daily on a continuous basis for patients with advanced or refractory solid tumors.


Condition Intervention Phase
Advanced Cancer
Drug: MKC-1
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies

Resource links provided by NLM:


Further study details as provided by EntreMed:

Primary Outcome Measures:
  • Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors. [ Time Frame: Throughout study participation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine evidence of benefit in cancer patients when MKC-1 is administered orally twice a day (bid) continuously by evaluating tumor response and/or tumor marker improvement. [ Time Frame: During study participation ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2008
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MKC-1
30 mg and 100 mg capsules, dosed BID daily on a continuous schedule

  Eligibility

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

Inclusion Criteria:

  • Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective.
  • Age greater than or equal to 18 years.
  • ECOG performance status ≤1
  • ANC greater than or equal to 1,500/mm3;
  • Platelets greater than or equal to 100,000/mm3
  • creatinine ≤1.5 times institutional upper limit of normal (ULN)
  • T Bili within normal limits;
  • AST and ALT less than or equal to 2.5 times ULN; and
  • albumin greater than or equal to 3.0 g/dL
  • have measurable disease by RECIST, radiographically evaluable disease, or detectable disease
  • women of child-bearing potential and men must agree to use adequate contraception
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Have previously received MKC-1.
  • Have received radiation to greater than 25% of the bone marrow.
  • Have had anti-cancer therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Are concurrently receiving any other investigational agents while on study.
  • Have known brain metastases
  • Have any condition that impairs the ability to swallow and retain MKC-1 capsules.
  • Uncontrolled intercurrent illness
  • Are pregnant or breastfeeding
  • HIV-positive patients
  • Patients with uncontrolled diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656461

Locations
United States, Wisconsin
U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
EntreMed
Investigators
Principal Investigator: Glenn Liu, MD U. of Wisconsin
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Miikana Therapeutics, an EntreMed, Inc. company
ClinicalTrials.gov Identifier: NCT00656461     History of Changes
Other Study ID Numbers: MKC-106
Study First Received: April 7, 2008
Last Updated: November 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by EntreMed:
Advanced cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014