NCT00504205

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable lymphoma

Timeline
Completed

Started May 2007

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 2, 2013

Status Verified

April 1, 2008

Enrollment Period

1.6 years

First QC Date

July 17, 2007

Last Update Submit

August 1, 2013

Conditions

LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissueintraocular lymphomanodal marginal zone B-cell lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent small lymphocytic lymphomasplenic marginal zone lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult T-cell leukemia/lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III mycosis fungoides/Sezary syndromestage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult T-cell leukemia/lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV mycosis fungoides/Sezary syndromestage IV small lymphocytic lymphomaWaldenstrom macroglobulinemiaprimary central nervous system non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (3)

  • Safety

  • Response to treatment according to RECIST criteria

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

Interventions

multitargeted receptor tyrosine kinase inhibitor MP470DRUG
laboratory biomarker analysisOTHER
pharmacological studyOTHER
positron emission tomographyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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:
  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85258-4512, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyIntraocular LymphomaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellPrecursor T-Cell Lymphoblastic Leukemia-LymphomaWaldenstrom Macroglobulinemia

Interventions

amuvatinibMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphadenopathyEye NeoplasmsNeoplasms by SiteLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Gregory Berk, MD

    Astex Pharmaceuticals, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

May 1, 2007

Primary Completion

December 1, 2008

Study Completion

March 1, 2010

Last Updated

August 2, 2013

Record last verified: 2008-04

Locations

US(2)