Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

NCT00729833

Last updated date
Study Location
Pfizer Investigational Site
Los Angeles, California, 90095, United States
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Cancer, Advanced Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.

- ECOG Performance Status of 0 or 1;

- Total IGF-1 level ≥100 ng/ml;

- ECOG Performance Status of 0 or 1

- Adequate bone marrow, renal, and hepatic function

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for
prostate cancer patients


- Treatment with any other investigational therapy within 4 weeks prior to study
treatment


- Major surgery within 4 weeks of study treatment


- Prior treatment that may increase the risk of cardiac complications


- Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater


- Significant active cardiac disease, including hypertension that cannot be controlled
by medications


- Greater than three (3) prior lines of cytotoxic therapy;


- Active infection


- Prior IGF-IR targeted therapy;

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Advanced Cancer, Advanced Solid TumorsStudy Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
NCT00729833
  1. Los Angeles, California
  2. Santa Monica, California
  3. Philadelphia, Pennsylvania
  4. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
Official Title  ICMJE Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
Brief Summary The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.
Detailed Description The study was closed to enrollment on 14 Jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with Pfizer's business decision to stop development of the figitumumab compound. Safety concerns did not contribute to the decision to terminate this clinical trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Advanced Solid Tumors
Intervention  ICMJE
  • Drug: CP-751,871
    CP-751,871 IV, every 3 weeks
  • Drug: Sunitinib
    Sunitinib - daily dosing
Study Arms  ICMJE Experimental: CP-751,871 + Sunitinib
Escalating cohorts of CP-751,871 + Sunitinib
Interventions:
  • Drug: CP-751,871
  • Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 7, 2008)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.
  • ECOG Performance Status of 0 or 1;
  • Total IGF-1 level ?100 ng/ml;
  • ECOG Performance Status of 0 or 1
  • Adequate bone marrow, renal, and hepatic function

Exclusion Criteria:

  • Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients
  • Treatment with any other investigational therapy within 4 weeks prior to study treatment
  • Major surgery within 4 weeks of study treatment
  • Prior treatment that may increase the risk of cardiac complications
  • Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater
  • Significant active cardiac disease, including hypertension that cannot be controlled by medications
  • Greater than three (3) prior lines of cytotoxic therapy;
  • Active infection
  • Prior IGF-IR targeted therapy;
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00729833
Other Study ID Numbers  ICMJE A4021024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP