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

NCT00729833 | Terminated Phase 1 Results

• 1 other identifier: A4021024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Cancer; Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose-Limiting Toxicities (DLT)

  Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (\>=) 7 days delay in administration of Cycle 2. Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.

  Baseline up to the end of Cycle 1 (each cycle=3 weeks)

Secondary Outcomes (14)

• Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0

  Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)

• Percentage of Participants With Hematologic Laboratory Test Abnormality

  Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)

• Percentage of Participants With Blood Chemistry Laboratory Test Abnormality

  Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)

• Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab

  0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab

  0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4

Study Arms (1)

CP-751,871 + Sunitinib

EXPERIMENTAL

Escalating cohorts of CP-751,871 + Sunitinib

Drug: CP-751,871; Drug: Sunitinib

Interventions

CP-751,871 DRUG

CP-751,871 IV, every 3 weeks

CP-751,871 + Sunitinib

Sunitinib DRUG

Sunitinib - daily dosing

CP-751,871 + Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

Santa Monica, California, 90404, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

figitumumab; Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

This study was terminated prematurely. Subsequently, ADA samples were not assayed and the pharmacokinetics of sunitinib plus its metabolite were not analyzed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 8, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: April 1, 2013
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

US (4)