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

NCT ID: NCT00321308

Last Updated: 2009-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-01-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Carcinoma, Non-Small Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B

Standard of care chemotherapy

Group Type ACTIVE_COMPARATOR

pemetrexed

Intervention Type DRUG

500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity

A

Standard of care chemotherapy plus experimental intervention (PF-3512676)

Group Type EXPERIMENTAL

pemetrexed + PF-3512676

Intervention Type DRUG

pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity

Interventions

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pemetrexed

500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity

Intervention Type DRUG

pemetrexed + PF-3512676

pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity

Intervention Type DRUG

Other Intervention Names

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Alimta Alimta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Litchfield Park, Arizona, United States

Site Status

Pfizer Investigational Site

Sun City, Arizona, United States

Site Status

Pfizer Investigational Site

Bentonville, Arkansas, United States

Site Status

Pfizer Investigational Site

Fayetteville, Arkansas, United States

Site Status

Pfizer Investigational Site

Hudson, Florida, United States

Site Status

Pfizer Investigational Site

New Port Richey, Florida, United States

Site Status

Pfizer Investigational Site

Mahwah, New Jersey, United States

Site Status

Pfizer Investigational Site

Midland Park, New Jersey, United States

Site Status

Pfizer Investigational Site

Paramus, New Jersey, United States

Site Status

Pfizer Investigational Site

Westwood, New Jersey, United States

Site Status

Pfizer Investigational Site

Oneida, New York, United States

Site Status

Pfizer Investigational Site

Oswego, New York, United States

Site Status

Pfizer Investigational Site

Syracuse, New York, United States

Site Status

Pfizer Investigational Site

Syracuse, New York, United States

Site Status

Pfizer Investigational Site

Sylvania, Ohio, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Pfizer Investigational Site

Großhansdorf, , Germany

Site Status

Pfizer Investigational Site

Mannheim, , Germany

Site Status

Pfizer Investigational Site

Torino, , Italy

Site Status

Countries

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United States Germany Italy

Related Links

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Other Identifiers

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A8501004

Identifier Type: -

Identifier Source: org_study_id

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