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Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Non-Small Cell Lung

Intervention: pemetrexed (Drug); pemetrexed + PF-3512676 (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen

Clinical Details

Official title: A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival

Secondary outcome:

Overall Survival

Overall Safety Profile

Patient Reported Outcome

Time to Tumor Progression

Overall Objective Response Rate

Duration of Response

Detailed description: PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Locally advanced or metastatic NSCLC

- Measurable disease

- ECOG PS 0 or 1

Exclusion Criteria:

- Known CNS metastasis

- Pre-existing autoimmune or antibody mediated disease

Locations and Contacts

Pfizer Investigational Site, Grosshansdorf 22927, Germany

Pfizer Investigational Site, Mannheim 68167, Germany

Pfizer Investigational Site, Torino 10126, Italy

Pfizer Investigational Site, Litchfield Park, Arizona 85340, United States

Pfizer Investigational Site, Sun City, Arizona 85351, United States

Pfizer Investigational Site, Bentonville, Arkansas 72712, United States

Pfizer Investigational Site, Fayetteville, Arkansas 72703, United States

Pfizer Investigational Site, Hudson, Florida 34667, United States

Pfizer Investigational Site, New Port Richey, Florida 34655, United States

Pfizer Investigational Site, Mahwah, New Jersey 07430, United States

Pfizer Investigational Site, Midland Park, New Jersey 07432, United States

Pfizer Investigational Site, Paramus, New Jersey 07652, United States

Pfizer Investigational Site, Westwood, New Jersey 07675, United States

Pfizer Investigational Site, Oneida, New York 13421, United States

Pfizer Investigational Site, Oswego, New York 13126, United States

Pfizer Investigational Site, Syracuse, New York 13210-2306, United States

Pfizer Investigational Site, Syracuse, New York 13210, United States

Pfizer Investigational Site, Sylvania, Ohio 43560, United States

Pfizer Investigational Site, Seattle, Washington 89109, United States

Pfizer Investigational Site, Seattle, Washington 98195, United States

Additional Information

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

Starting date: September 2006
Last updated: September 24, 2009

Page last updated: August 20, 2015

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