CP-751,871 Treatment For Patients With Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: CP-751,871

• Registration Number: NCT01536145
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-20
• Results First Submitted: 2013-01-18
• Results First Submitted QC: 2013-01-18
• Results First Posted: 2013-02-28
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-12
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single agent CP-751,871	CP-751,871	dose escalation design

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	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

Secondary Outcome Measures

Name	Time	Method
Single Dose End-of-infusion Concentration (Cinf) for CP-751,871	1 hour postdose in Cycle 1
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
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
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
Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] 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
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
Multiple Dose Cinf for CP-751,871	1 hour postdose in Cycles 2 up to 16
Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871	0 hour (predose) in Cycles 2 up to 16
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
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
Pharmacodynamic-based Dose	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
Percentage of Participants With Objective Response (OR)	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	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 \[PD\])

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New York, New York, United States