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Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer, Advanced Solid Tumors

Thank you

Trial Information

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 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.


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;

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) of CP-751,871 and sunitinib when given in combination in patients with advanced solid tumors

Outcome Time Frame:

3 Years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4021024

NCT ID:

NCT00729833

Start Date:

September 2008

Completion Date:

April 2013

Related Keywords:

  • Advanced Cancer
  • Advanced Solid Tumors
  • Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535