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