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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01536145
Other study ID # A4021001
Secondary ID
Status Completed
Phase Phase 1
First received February 14, 2012
Last updated March 12, 2013
Start date December 2003
Est. completion date June 2008

Study information

Verified date March 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Rochester Minnesota
United States Pfizer Investigational Site Scottsdale Arizona
United States Pfizer Investigational Site Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants Baseline up to Cycle 1 (Week 4 or Week 8) Yes
Secondary Single Dose End-of-infusion Concentration (Cinf) for CP-751,871 1 hour postdose in Cycle 1 No
Secondary Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871 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 No
Secondary Single Dose Volume of Distribution (Vz) for CP-751,871 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 No
Secondary Single Dose Plasma Decay Half-life (t1/2) for CP-751,871 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 No
Secondary Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] for CP-751,871 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 No
Secondary Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871 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 No
Secondary Single Dose Systemic Clearance (CL) for CP-751,871 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 No
Secondary Multiple Dose Cinf for CP-751,871 1 hour postdose in Cycles 2 up to 16 No
Secondary Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871 0 hour (predose) in Cycles 2 up to 16 No
Secondary Pharmacodynamic-based Dose 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 Cycle 1 (Week 4 or Week 8) No
Secondary Human Anti-human Antibody (HAHA) Response to CP-751,871 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 No
Secondary Percentage of Participants With Objective Response (OR) 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). Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose) No
Secondary Time to Disease Progression 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]) Baseline up to end of treatment No
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