CP-751,871 Treatment For Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

An Open Label Phase I Study Of CP-751,871 In Patients With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536145
• Other study ID #: A4021001
• 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

• Multiple Myeloma
• Neoplasms, Plasma Cell

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

External Links

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