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Completed

NCT Number: NCT00728390

A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.

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Key information

Conditions

Carcinoma, Non-Small Cell Carcinoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Villejuif, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically documented advanced cancer, Eastern Cooperative Oncology Group (ECOG) 0-1;
  • Platelets > 100,000, ANC > 1500;
  • Ccr > 60 or serum creat. <1.5
  • Non-small cell cancer cohort:
  • Eastern Cooperative Oncology Group (ECOG) 0-2, prior platin, < 4 prior chemotherapy regimen
  • HgA1C <5.7%

Exclusion criteria

  • Active Central Nervous System (CNS) metastases;
  • prior IGF1-R targeted therapy
  • Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.

Treatment and study plan

PF-00299804

Drug

CP-751,871 at recommended dose on Day 1 and 2 of cycle 1, then on Day 1 every 3 weeks; and PF-00299804 orally at recommended dose once daily.

Primary outcomes

  1. Overall safety profile characterized by type, frequency, severity (as graded using NCI CTC AE v. 3.0), timing, seriousness and relationship to trial treatment of adverse events and laboratory abnormalities.

    Time frame: 18 months

Secondary outcomes

  1. Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871

    Time frame: 12 months

  2. Progression Free Survival (PFS)

    Time frame: 15 months

  3. Best overall response (OR) defined according to RECIST guidelines.

    Time frame: 12 months

  4. Duration of response (DR)

    Time frame: 15 months

  5. Anti-Drug Antibodies (ADA) response;

    Time frame: 18 months

  6. KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Aug 5, 2008
Registry last updated
Apr 22, 2024

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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