Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT00656461
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00656461
Study Brief:
Protocol Section:
NCT00656461