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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656461
• Other study ID #: MKC-106
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2008
• Last updated: November 23, 2009
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: CASI Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• MKC-1
30 mg and 100 mg capsules, dosed BID daily on a continuous schedule

Locations

Country	Name	City	State
United States	U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
CASI Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No