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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, 90095 United States
Contact
1-800-718-1021
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;

NCT00729833
Pfizer
Terminated
Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

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Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
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.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced Cancer
  • Advanced Solid Tumors
  • Drug: CP-751,871
    CP-751,871 IV, every 3 weeks
  • Drug: Sunitinib
    Sunitinib - daily dosing
Experimental: CP-751,871 + Sunitinib
Escalating cohorts of CP-751,871 + Sunitinib
Interventions:
  • Drug: CP-751,871
  • Drug: Sunitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
April 2013
August 2011   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00729833
A4021024
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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