Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors

NCT00474760 | Completed Phase 1 Results

• 1 other identifier: A4021010
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 3

Brief Summary

This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).

Conditions

Sarcoma, Ewing's

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

  Baseline up to 150 days after the last administration of study drug

Secondary Outcomes (26)

• Maximum Observed Plasma Concentration (Cmax) in Cycle 1

  Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

• Maximum Observed Plasma Concentration (Cmax) in Cycle 4

  Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1

  Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4

  Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

• Plasma Decay Half-Life (t1/2) in Cycle 1

  Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

Study Arms (1)

1

EXPERIMENTAL

Drug: CP-751,871

Interventions

CP-751,871 DRUG

Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity

1

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Ewing's sarcoma family tumors

You may not qualify if:

• Concurrent treatment with any other anti tumor agents

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Ann Arbor, Michigan, 48109-0848, United States

Location

Pfizer Investigational Site

Rochester, Minnesota, 55905, United States

Location

Pfizer Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (2)

• Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.

  PMID: 22682017 DERIVED

• Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, Batzel GN, Yin D, Pritchard-Jones K, Judson I, Worden FP, Gualberto A, Scurr M, de Bono JS, Haluska P. Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol. 2010 Feb;11(2):129-35. doi: 10.1016/S1470-2045(09)70354-7. Epub 2009 Dec 23.

  PMID: 20036194 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Sarcoma, Ewing

Interventions

figitumumab

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Limitations and Caveats

The study was completed and 2 participants in figitumumab 20 mg/kg RP2D ESFT group were transitioned to compassionate figitumumab treatment as investigators judged they were receiving benefit from the protocol therapy.

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: August 1, 2005
• Primary Completion: January 1, 2011
• Study Completion: October 1, 2012
• Last Updated: December 17, 2013
• Results First Posted: December 17, 2013

Record last verified: 2013-10

Locations

US (2); GB (1)