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

NCT00656461 | Completed Phase 1

• 1 other identifier: MKC-106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

Advanced cancer

Outcome Measures

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.

  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.

  During study participation

Study Arms (1)

1

EXPERIMENTAL

Drug: MKC-1

Interventions

MKC-1 DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (1)

U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Study Officials

• Glenn Liu, MD

  U. of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

US (1)