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

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: MKC-1

• Registration Number: NCT00656461
• Lead Sponsor: CASI Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-07
• Study First Posted: 2008-04-11
• Primary Completion: 2009-07
• Status Verified: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-23
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MKC-1	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States