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Trial record 1 of 1 for:    NCT01536145
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CP-751,871 Treatment For Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01536145
Recruitment Status : Completed
First Posted : February 20, 2012
Results First Posted : February 28, 2013
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 14, 2012
First Posted Date  ICMJE February 20, 2012
Results First Submitted Date  ICMJE January 18, 2013
Results First Posted Date  ICMJE February 28, 2013
Last Update Posted Date March 15, 2013
Study Start Date  ICMJE December 2003
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
Maximum Tolerated Dose (MTD) [ Time Frame: Baseline up to Cycle 1 (Week 4 or Week 8) ]
The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
  • Maximum tolerated dose (MTD) [patients treated at doses ≤ 0.15 mg/kg] [ Time Frame: 4 weeks ]
  • Maximum tolerated dose (MTD) [patients treated at doses > 0.15 mg/kg] [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
  • Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 [ Time Frame: 1 hour postdose in Cycle 1 ]
  • Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 [ Time Frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose ]
  • Single Dose Volume of Distribution (Vz) for CP-751,871 [ Time Frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose ]
  • Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 [ Time Frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose ]
  • Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871 [ Time Frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose ]
  • Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 [ Time Frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose ]
  • Single Dose Systemic Clearance (CL) for CP-751,871 [ Time Frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose ]
  • Multiple Dose Cinf for CP-751,871 [ Time Frame: 1 hour postdose in Cycles 2 up to 16 ]
  • Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871 [ Time Frame: 0 hour (predose) in Cycles 2 up to 16 ]
  • Pharmacodynamic-based Dose [ Time Frame: Cycle 1 (Week 4 or Week 8) ]
    The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression
  • Human Anti-human Antibody (HAHA) Response to CP-751,871 [ Time Frame: 30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg ]
  • Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose) ]
    Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).
  • Time to Disease Progression [ Time Frame: Baseline up to end of treatment ]
    Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. Tumor progression was determined from oncologic assessment data (where data met the criteria for progressive disease [PD])
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
  • Single dose end of infusion concentration [Cinf] for CP-751,871 [ Time Frame: Cycle 1: Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Single dose initial volume distribution [Vd] for CP-751,871 [ Time Frame: Cycle 1: Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Single dose area under plasma disposition curve from 0 to last time point [AUC0-Tlast] with measurable CP-751, 871 [ Time Frame: Cycle 1: Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Single dose terminal disposition phase half-life [t1/2] for CP-751, 871 [ Time Frame: Cycle 1: Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Single dose area under the plasma disposition curve from 0 to infinity [AUC0-inf] for CP-751, 871 [ Time Frame: Cycle 1: Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Single dose clearance rate [CL] for CP-751,871 [ Time Frame: Cycle 1: Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Single dose steady-state volume [Vss] for CP-751,871 [ Time Frame: Cycle 1:Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Single dose area under the plasma moment curved from 0 to infinity [AUMC0-inf] for CP-751,871 [ Time Frame: Cycle 1: Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Multiple dose end infusion concentration [Cinf] for CP-751,871 [ Time Frame: Cycle 1: Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Multiple dose concentration at the end of the dosing interval [Cmin] for CP-751,871 [ Time Frame: Cycle 1: Days 1, 2, 3, 4, 8, 15, 22 and 29; 30-60 days post last dose of CP-751,871 ]
  • Pharmacodynamics: serum Insulin Growth Factor-1, IGF binding protein-3 and acid-labile subunit [ Time Frame: Cycle 1 pre-dose, 48,72 hrs post dose; day 43; subsequent cycles day 1 pre-dose ]
  • Human Anti-Human Antibodies [HAHA] [ Time Frame: Cycle 1 Day 1 pre-dosing, day 1 of each cycle, and end of study [30-60 days post last dose] ]
  • Response rate [ Time Frame: Baseline, Day 1 at pre-dosing/cycle, end of study [30-60 days post last dose] ]
  • Time to disease progression [ Time Frame: Baseline, Day 1 at pre-dosing/cycle, end of study [30-60 days post last dose] ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CP-751,871 Treatment For Patients With Multiple Myeloma
Official Title  ICMJE An Open Label Phase I Study Of CP-751,871 In Patients With Multiple Myeloma
Brief Summary This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: CP-751,871
CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability
Study Arms  ICMJE Experimental: Single agent CP-751,871
dose escalation design
Intervention: Drug: CP-751,871
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2012)
47
Original Actual Enrollment  ICMJE
 (submitted: February 15, 2012)
50
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously treated multiple myeloma with a quantifiable serum (M spike ≥ 1 g/dL) and/or urine (≥ 200 mg/24-hr) paraprotein
  • Adequate bone marrow, renal, liver and cardiac function
  • Eastern Cooperative Oncology Group [ECOG] performance status less than or equal to 2

Exclusion Criteria:

  • Prior allogeneic stem cell transplant (alloSCT)
  • Myelosuppressive chemotherapy or immunotherapy within 3 weeks prior to treatment with CP-751,871
  • Prior organ allograft
  • Concurrent use of insulin, oral hypoglycemic medication, growth hormone (GH), or growth hormone inhibitors
  • Female patients who are pregnant or lactating
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 NCT01536145
Other Study ID Numbers  ICMJE A4021001
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 March 2013

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