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

Primary Purpose

Carcinoma, Non-Small Cell Lung

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
pemetrexed
pemetrexed + PF-3512676
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small Cell Lung focused on measuring advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

B

A

Arm Description

Standard of care chemotherapy

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

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall Survival
Overall Safety Profile
Patient Reported Outcome
Time to Tumor Progression
Overall Objective Response Rate
Duration of Response

Full Information

First Posted
May 2, 2006
Last Updated
September 24, 2009
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00321308
Brief Title
Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Why Stopped
See Termination Reason in Detailed Description.
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small Cell Lung
Keywords
advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Active Comparator
Arm Description
Standard of care chemotherapy
Arm Title
A
Arm Type
Experimental
Arm Description
Standard of care chemotherapy plus experimental intervention (PF-3512676)
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
pemetrexed + PF-3512676
Other Intervention Name(s)
Alimta
Intervention Description
pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
110 Events
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Time of death
Title
Overall Safety Profile
Time Frame
28 days post treatment
Title
Patient Reported Outcome
Time Frame
End of Treatment
Title
Time to Tumor Progression
Time Frame
End of treatment
Title
Overall Objective Response Rate
Time Frame
Time of disease progressive disease
Title
Duration of Response
Time Frame
Time of disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
Pfizer Investigational Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Pfizer Investigational Site
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Pfizer Investigational Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Pfizer Investigational Site
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Pfizer Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Pfizer Investigational Site
City
Mahwah
State/Province
New Jersey
ZIP/Postal Code
07430
Country
United States
Facility Name
Pfizer Investigational Site
City
Midland Park
State/Province
New Jersey
ZIP/Postal Code
07432
Country
United States
Facility Name
Pfizer Investigational Site
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Pfizer Investigational Site
City
Westwood
State/Province
New Jersey
ZIP/Postal Code
07675
Country
United States
Facility Name
Pfizer Investigational Site
City
Oneida
State/Province
New York
ZIP/Postal Code
13421
Country
United States
Facility Name
Pfizer Investigational Site
City
Oswego
State/Province
New York
ZIP/Postal Code
13126
Country
United States
Facility Name
Pfizer Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2306
Country
United States
Facility Name
Pfizer Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Pfizer Investigational Site
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
89109
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Pfizer Investigational Site
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8501004&StudyName=Trial%20of%20Pemetrexed%20With%20or%20Without%20PF-3512676%20in%20Advanced%20Non-Small%20Cell%20Lung%20Cancer
Description
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Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer

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