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

This study has been completed.
Sponsor:
Information provided by:
CASI Pharmaceuticals, Inc.
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 CASI Pharmaceuticals, Inc.:

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
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: NCT00656461

Locations
United States, Wisconsin
U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
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 CASI Pharmaceuticals, Inc.:
Advanced cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014