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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small Cell Lung

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

110 Events

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8501004

NCT ID:

NCT00321308

Start Date:

September 2006

Completion Date:

January 2008

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteLivingston, New Jersey  07039