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

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NCT00321308

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Litchfield Park, Arizona, 85340 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Locally advanced or metastatic NSCLC

- Measurable disease

- ECOG PS 0 or 1

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Known CNS metastasis

- Pre-existing autoimmune or antibody mediated disease

NCT00321308
Pfizer
Terminated
Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer

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[email protected]

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Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
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
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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small Cell Lung
  • Drug: pemetrexed
    500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
    Other Name: Alimta
  • Drug: pemetrexed + PF-3512676
    pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
    Other Name: Alimta
  • Active Comparator: B
    Standard of care chemotherapy
    Intervention: Drug: pemetrexed
  • Experimental: A
    Standard of care chemotherapy plus experimental intervention (PF-3512676)
    Intervention: Drug: pemetrexed + PF-3512676
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
36
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   United States
 
 
NCT00321308
A8501004
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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