Clinical trial NCT01536145: CP-751,871 Treatment For Patients With Multiple Myeloma
Official title: An Open Label Phase I Study Of CP-751,871 In Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: IGF-1R inhibitor
CP-751871
multiple myeloma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-02-20
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Baseline up to Cycle 1 (Week 4 or Week 8)
Secondary outcomes:
measure: Single Dose End-of-infusion Concentration (Cinf) for CP-751,871
timeFrame: 1 hour postdose in Cycle 1
measure: Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871
timeFrame: 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
measure: Single Dose Volume of Distribution (Vz) for CP-751,871
timeFrame: 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
measure: Single Dose Plasma Decay Half-life (t1/2) for CP-751,871
timeFrame: 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
measure: Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871
timeFrame: 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
measure: Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871
timeFrame: 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
measure: Single Dose Systemic Clearance (CL) for CP-751,871
timeFrame: 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
measure: Multiple Dose Cinf for CP-751,871
timeFrame: 1 hour postdose in Cycles 2 up to 16
measure: Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871
timeFrame: 0 hour (predose) in Cycles 2 up to 16
measure: Pharmacodynamic-based Dose
timeFrame: Cycle 1 (Week 4 or Week 8)
measure: Human Anti-human Antibody (HAHA) Response to CP-751,871
timeFrame: 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
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)
measure: Time to Disease Progression
timeFrame: Baseline up to end of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: