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

April 7, 2008
November 23, 2009
March 2008
July 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00656461 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Phase 1 Study of MKC-1 in Patients With Advanced Cancer
Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Cancer
Drug: MKC-1
30 mg and 100 mg capsules, dosed BID daily on a continuous schedule
Experimental: 1
Intervention: Drug: MKC-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00656461
MKC-106
No
Chief Medical Officer, Miikana Therapeutics, an EntreMed, Inc. company
CASI Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Glenn Liu, MD U. of Wisconsin
CASI Pharmaceuticals, Inc.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP