MP470 in Treating Patients With Unresectable or Metastatic Solid Tumor or Lymphoma
NCT ID: NCT00504205
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2007-05-31
2010-03-31
Brief Summary
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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.
Detailed Description
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Primary
* Estimate the maximum tolerated dose (MTD) and define the safety profile of multitargeted receptor tyrosine kinase inhibitor MP470 in humans.
Secondary
* Estimate the therapeutic response rate for patients receiving MP470.
* Define the human pharmacokinetic (PK) and pharmacodynamic (PD) profiles of MP470 capsules
* Evaluate PK-PD relationships.
OUTLINE: This is a multicenter study.
Patients receive oral multitargeted receptor tyrosine kinase inhibitor MP470 until the maximum tolerated dose is determined.
Pharmacokinetic and pharmacodynamic analyses are carried out to determine changes in phosphorylation of extracellular signal-regulated kinase (ERK), Rad51 expression, number of circulating tumor cells (CTCs), and tumor glucose metabolism measured by 2-\[18F\]fluoro-2-deoxyglucose positron emission tomography (FDG-PET).
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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multitargeted receptor tyrosine kinase inhibitor MP470
laboratory biomarker analysis
pharmacological study
positron emission tomography
Eligibility Criteria
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Inclusion Criteria
* Patients with refractory lymphoma (Hodgkin or non-Hodgkin) are also permitted to participate
* 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
* Recuperated from any prior surgical procedures including at least 4 weeks rest since a major surgery
Exclusion Criteria
PATIENT CHARACTERISTICS:
* 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:
* 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
18 Years
ALL
No
Sponsors
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Astex Pharmaceuticals, Inc.
INDUSTRY
Principal Investigators
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Gregory Berk, MD
Role: STUDY_CHAIR
Astex Pharmaceuticals, Inc.
Locations
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Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Countries
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Other Identifiers
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CDR0000556524
Identifier Type: REGISTRY
Identifier Source: secondary_id
VPCCS-SGI-0470-01
Identifier Type: -
Identifier Source: secondary_id
SUPERGEN-SGI-0470-01
Identifier Type: -
Identifier Source: org_study_id