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TerminatedNCT00504205Updated Aug 2, 2013

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

An interventional study of multitargeted receptor tyrosine kinase inhibitor MP470 and laboratory biomarker analysis in Lymphoma and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Astex Pharmaceuticals, Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.

Sponsored by Astex Pharmaceuticals, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Withdrawn as trial was never activated by SuperGen
Phase
Not applicable
Study type
Interventional
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

OBJECTIVES:

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).

02

Conditions studied

  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • intraocular lymphoma
  • nodal marginal zone B-cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent small lymphocytic lymphoma
  • splenic marginal zone lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III mycosis fungoides/Sezary syndrome
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV mycosis fungoides/Sezary syndrome
  • stage IV small lymphocytic lymphoma
  • Waldenstrom macroglobulinemia
  • primary central nervous system non-Hodgkin lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Astex Pharmaceuticals, Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 6 (46%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Enrollment
30 participants (estimated)

Interventions

  • Drugmultitargeted receptor tyrosine kinase inhibitor MP470
  • Otherlaboratory biomarker analysis
  • Otherpharmacological study
  • Procedurepositron emission tomography
06

What researchers measure

Primary outcomes

  1. Safety

  2. Response to treatment according to RECIST criteria

  3. Pharmacodynamic assessments (e.g., changes in phosphorylation of ERK, Rad51 expression, number of CTCs, and tumor glucose metabolism measured by FDG-PET)

07

Study locations

2 sites
  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
    Scottsdale, Arizona 85258-4512, United States
  • South Texas Accelerated Research Therapeutics
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00504205
Lead sponsor
Astex Pharmaceuticals, Inc.
First posted
Jul 19, 2007
Start date
May 2007
Primary completion
Dec 2008
Completion
Mar 2010
Last update
Aug 2, 2013

Study contacts

Gregory Berk, MD
study chair · Astex Pharmaceuticals, Inc.
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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