NCT01536145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Dec 2003

Typical duration for phase_1 multiple-myeloma

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 28, 2013

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

4.5 years

First QC Date

February 14, 2012

Results QC Date

January 18, 2013

Last Update Submit

March 12, 2013

Conditions

Multiple Myeloma

Keywords

IGF-1R inhibitorCP-751871multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (13)

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

    1 hour postdose in Cycle 1

  • 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 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 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

  • +8 more secondary outcomes

Study Arms (1)

Single agent CP-751,871

EXPERIMENTAL

dose escalation design

Drug: CP-751,871

Interventions

CP-751,871DRUG

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

Single agent CP-751,871

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pfizer Investigational Site

Phoenix, Arizona, 85054, United States

Location

Pfizer Investigational Site

Scottsdale, Arizona, 85259, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33612, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Rochester, Minnesota, 55905, United States

Location

Pfizer Investigational Site

New York, New York, 10011-5903, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

figitumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 20, 2012

Study Start

December 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 15, 2013

Results First Posted

February 28, 2013

Record last verified: 2013-03

Locations

US(6)