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:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT00504205
Eligibility Criteria:
DISEASE CHARACTERISTICS:
Inclusion criteria:
* Histological or cytological diagnosis of unresectable or metastatic solid-tumor cancer that is refractory to standard therapies OR for which no standard therapy exists
* Patients with refractory lymphoma (Hodgkin or non-Hodgkin) are also permitted to participate
Exclusion criteria:
* Active CNS metastases (primary brain tumors are permitted)
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Karnofsky performance status ≥ 70%
* Hemoglobin ≥ 9 g/dL
* ANC ≥ 1.5 × 10\^9/L
* Platelet count ≥ 100 × 10\^9/L
* Total serum bilirubin ≤ 2 mg/dL
* AST and ALT ≤ 2.5 × ULN (upper limit of normal for the clinical laboratory), but ≤ 5 × ULN is acceptable if due to hepatic metastases
* Serum albumin ≥ 2 g/dL
* Serum creatinine ≤ 2 mg/dL
* LVEF ≥ 50% on ECHO
* No significant abnormalities on the screening ECG (e.g., left bundle branch block, 3rd degree AV block, acute myocardial infarction or QTc interval \> 450 msec)
* No history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome)
* Able to swallow MP470 capsules
* Capable of fasting for 6 hours
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months following completion of study treatment
Exclusion criteria:
* Life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of oral MP470, or put the study outcomes at risk
* Any serious, uncontrolled active infection that requires systemic treatment
* History of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, and/or myocardial infarction
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* Recuperated from any prior surgical procedures including at least 4 weeks rest since a major surgery
Exclusion criteria:
* Patient has received any anticancer agent(s) within the past 3 weeks, including investigational agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic, or hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonists
* Patient has received radiation therapy within the past 4 weeks
* Patient has a grade 2 or more severe toxicity (other than alopecia) continuing from prior anticancer therapy
* Patient requires treatment with immunosuppressive agents other than corticosteroids that have been at stable doses for at least 2 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00504205
Study Brief:
Protocol Section:
NCT00504205