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Trial record 1 of 1 for:    NCT00729833
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Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00729833
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : August 8, 2008
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 30, 2008
First Posted Date  ICMJE August 8, 2008
Results First Submitted Date  ICMJE April 11, 2014
Results First Posted Date  ICMJE June 9, 2014
Last Update Posted Date June 9, 2014
Study Start Date  ICMJE September 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2014)
Number of Participants With Dose-Limiting Toxicities (DLT) [ Time Frame: Baseline up to the end of Cycle 1 (each cycle=3 weeks) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
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: 15Jan10 ]
Change History Complete list of historical versions of study NCT00729833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2014)
  • 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) ]
    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).
  • 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) ]
    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).
  • 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) ]
    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).
  • 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 ]
  • 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 ]
    AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.
  • 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 ]
    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.
  • 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 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • 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 ]
  • 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 ]
  • 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 ]
    AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).
  • Trough Plasma Concentration (Ctrough) of Sunitinib [ Time Frame: 0.5 hour predose on Day 1 of Cycle 2 ]
  • Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib [ Time Frame: 24 hours postdose on Day 15 of Cycle 1 ]
  • 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) ]
    Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.
  • 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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
  • To evaluate the potential development of Anti-Drug Antibodies (ADA) in response to CP-751,871 [ Time Frame: 15Jan10 ]
  • To document evidence of antitumor activity in patients with measurable disease, of CP-751,871 when given in combination with sunitinib [ Time Frame: 15Jan10 ]
  • To define the overall safety and tolerability profile of CP-751,871 and sunitinib when given in combination [ Time Frame: 15Jan10 ]
  • To characterize the PK of CP-751,871 and sunitinib (and its metabolite SU012662) when given in combination [ Time Frame: 15Jan10 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
Official Title  ICMJE Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Advanced Solid Tumors
Intervention  ICMJE
  • Drug: CP-751,871
    CP-751,871 IV, every 3 weeks
  • Drug: Sunitinib
    Sunitinib - daily dosing
Study Arms  ICMJE Experimental: CP-751,871 + Sunitinib
Escalating cohorts of CP-751,871 + Sunitinib
Interventions:
  • Drug: CP-751,871
  • Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 7, 2008)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00729833
Other Study ID Numbers  ICMJE A4021024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP