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Completed

NCT Number: NCT00560235

Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors

Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors

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Key information

Conditions

Ewing's Sarcoma Family of Tumors

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pfizer Investigational Site, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ewing's family of tumors
  • Current disease state for which there is no curative therapy

Exclusion criteria

  • Prior anti-IGF-1R therapy
  • Concurrent treatment with other anti-cancer agents

Treatment and study plan

CP-751,871

Drug

Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Baseline and every cycle (4 weeks), for up to 6 cycles

    Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Baseline and every cycle (4 weeks), until progression or death

    PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).

  2. Overall Survival (OS)

    Time frame: Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment

    Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1

  4. Minimum Observed Plasma Trough Concentration (Cmin)

    Time frame: Cycle 6: predose on Day 1

    Cmin is the concentration at the end of treatment cycle (next cycle predose).

  5. Plasma Concentration at End of Infusion (Cendinf)

    Time frame: Cycle 1 Day 2 and Cycle 5 Day 1

  6. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

    Time frame: Cycle 5: 1 hour post-infusion on Day 1

    The dosing interval was 1 cycle (4 weeks) in this study.

  7. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1

    AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.

  8. Number of Participants With Positive Anti-Drug Antibody (ADA) Titer

    Time frame: Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)

    Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer <6.64 corresponded to negative ADA category value.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Nov 19, 2007
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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