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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00729833
First received: July 30, 2008
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Advanced Cancer
Advanced Solid Tumors
Drug: CP-751,871
Drug: Sunitinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) of CP-751,871 and sunitinib when given in combination in patients with advanced solid tumors [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the potential development of Anti-Drug Antibodies (ADA) in response to CP-751,871 [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • To document evidence of antitumor activity in patients with measurable disease, of CP-751,871 when given in combination with sunitinib [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • To characterize the PK of CP-751,871 and sunitinib (and its metabolite SU012662) when given in combination [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • To define the overall safety and tolerability profile of CP-751,871 and sunitinib when given in combination [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: September 2008
Study Completion Date: April 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP-751,871 + Sunitinib
Escalating cohorts of CP-751,871 + Sunitinib
Drug: CP-751,871
CP-751,871 IV, every 3 weeks
Drug: Sunitinib
Sunitinib - daily dosing

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729833

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Santa Monica, California, United States, 90404
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00729833     History of Changes
Other Study ID Numbers: A4021024
Study First Received: July 30, 2008
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014