NCT00656461CompletedPhase 1
Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- CASI Pharmaceuticals, Inc.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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
Arms & Interventions
1
Experimental
Intervention: MKC-1 (Drug)
Outcomes
Primary Outcomes
Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors.
Time Frame: Throughout study participation
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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