Clinical trial NCT00729833: Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Cancer
Advanced Solid Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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;

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicities (DLT)
timeFrame: Baseline up to the end of Cycle 1 (each cycle=3 weeks)
Secondary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0
timeFrame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
measure: Percentage of Participants With Hematologic Laboratory Test Abnormality
timeFrame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
measure: Percentage of Participants With Blood Chemistry Laboratory Test Abnormality
timeFrame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
measure: Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab
timeFrame: 0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
timeFrame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4
measure: Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab
timeFrame: 0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4
measure: Plasma Decay Half-Life (t1/2) of Figitumumab
timeFrame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4
measure: Maximum Observed Plasma Concentration (Cmax) of Sunitinib
timeFrame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib
timeFrame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
measure: Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib
timeFrame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
measure: Trough Plasma Concentration (Ctrough) of Sunitinib
timeFrame: 0.5 hour predose on Day 1 of Cycle 2
measure: Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib
timeFrame: 24 hours postdose on Day 15 of Cycle 1
measure: Number of Participants With Anti-Drug Antibodies (ADA)
timeFrame: 0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)
measure: Number of Participants With Objective Response (OR)
timeFrame: Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: