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OpenTrials
Completed

NCT Number: NCT00656461

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

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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MKC-1

Drug

30 mg and 100 mg capsules, dosed BID daily on a continuous schedule

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

CASI pharmaceuticals, Inc.

Industry

Registry information

Official study title

Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 11, 2008
Registry last updated
Nov 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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