MP470 in Treating Patients With Unresectable or Metastatic Solid Tumor or Lymphoma

Stopped early · Not applicable

Conditions studied: Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

In brief

RATIONALE: MP470 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This clinical trial is studying the side effects and best dose of MP470 in treating patients with unresectable or metastatic refractory solid tumor, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.

Key facts

Study ID

NCT00504205

Run by

Astex Pharmaceuticals, Inc.

People needed

30

Starts

2007-05-01

Expected to finish

2010-03-01

Last updated by the study team

2013-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:

Where it is running

• Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea — Scottsdale, Arizona, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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