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

CASI Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: MKC-1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00656461

MKC-106

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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