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CP-751,871 Treatment For Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CP-751,871

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring IGF-1R inhibitor, CP-751871, multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single agent CP-751,871

Arm Description

dose escalation design

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Single Dose End-of-infusion Concentration (Cinf) for CP-751,871

Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871

Single Dose Volume of Distribution (Vz) for CP-751,871

Single Dose Plasma Decay Half-life (t1/2) for CP-751,871

Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871

Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871

Single Dose Systemic Clearance (CL) for CP-751,871

Multiple Dose Cinf for CP-751,871

Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871

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

Human Anti-human Antibody (HAHA) Response to CP-751,871

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).

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])

Full Information

NCT ID

NCT01536145

First Posted

February 14, 2012

Last Updated

March 12, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01536145

Brief Title

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

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

December 2003 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

IGF-1R inhibitor, CP-751871, multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single agent CP-751,871

Arm Type

Experimental

Arm Description

dose escalation design

Intervention Type

Drug

Intervention Name(s)

CP-751,871

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose (MTD)

Description

The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants

Time Frame

Baseline up to Cycle 1 (Week 4 or Week 8)

Secondary Outcome Measure Information:

Title

Single Dose End-of-infusion Concentration (Cinf) for CP-751,871

Time Frame

1 hour postdose in Cycle 1

Title

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

Title

Single Dose Volume of Distribution (Vz) for CP-751,871

Time Frame