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

Phase 1
18 Years
Not Enrolling
Advanced Cancer

Thank you

Trial Information

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

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

- 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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

Throughout study participation

Safety Issue:


Principal Investigator

Glenn Liu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

U. of Wisconsin


United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

November 2009

Related Keywords:

  • Advanced Cancer
  • Advanced cancer
  • Neoplasms



U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792