- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00729833
Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
May 21, 2014 updated by: Pfizer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- Pfizer Investigational Site
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Santa Monica, California, United States, 90404
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Pfizer Investigational Site
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Texas
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San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: CP-751,871 + Sunitinib
Escalating cohorts of CP-751,871 + Sunitinib
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CP-751,871 IV, every 3 weeks
Sunitinib - daily dosing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Dose-Limiting Toxicities (DLT)
Time Frame: Baseline up to the end of Cycle 1 (each cycle=3 weeks)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0
Time Frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
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An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).
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Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
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Percentage of Participants With Hematologic Laboratory Test Abnormality
Time Frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
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Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).
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Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
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Percentage of Participants With Blood Chemistry Laboratory Test Abnormality
Time Frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
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Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).
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Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
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Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab
Time Frame: 0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4
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0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
Time Frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4
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AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.
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0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4
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Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab
Time Frame: 0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4
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AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.
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0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4
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Plasma Decay Half-Life (t1/2) of Figitumumab
Time Frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4
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Maximum Observed Plasma Concentration (Cmax) of Sunitinib
Time Frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
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0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib
Time Frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
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0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
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Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib
Time Frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
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AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).
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0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
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Trough Plasma Concentration (Ctrough) of Sunitinib
Time Frame: 0.5 hour predose on Day 1 of Cycle 2
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0.5 hour predose on Day 1 of Cycle 2
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Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib
Time Frame: 24 hours postdose on Day 15 of Cycle 1
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24 hours postdose on Day 15 of Cycle 1
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Number of Participants With Anti-Drug Antibodies (ADA)
Time Frame: 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)
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Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.
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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)
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Number of Participants With Objective Response (OR)
Time Frame: Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)
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Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST.
CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed).
PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR.
Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
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Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
April 1, 2013
Study Registration Dates
First Submitted
July 30, 2008
First Submitted That Met QC Criteria
August 7, 2008
First Posted (ESTIMATE)
August 8, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 9, 2014
Last Update Submitted That Met QC Criteria
May 21, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4021024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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