NCT00321308

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
3 countries

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

September 28, 2009

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

May 2, 2006

Last Update Submit

September 24, 2009

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    110 Events

Secondary Outcomes (6)

  • Overall Survival

    Time of death

  • Overall Safety Profile

    28 days post treatment

  • Patient Reported Outcome

    End of Treatment

  • Time to Tumor Progression

    End of treatment

  • Overall Objective Response Rate

    Time of disease progressive disease

  • +1 more secondary outcomes

Study Arms (2)

B

ACTIVE COMPARATOR

Standard of care chemotherapy

Drug: pemetrexed

A

EXPERIMENTAL

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

Drug: pemetrexed + PF-3512676

Interventions

pemetrexedDRUG

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

Also known as: Alimta
B
pemetrexed + PF-3512676DRUG

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

Also known as: Alimta
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally advanced or metastatic NSCLC
  • Measurable disease
  • ECOG PS 0 or 1

You may not qualify if:

  • Known CNS metastasis
  • Pre-existing autoimmune or antibody mediated disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Pfizer Investigational Site

Litchfield Park, Arizona, 85340, United States

Location

Pfizer Investigational Site

Sun City, Arizona, 85351, United States

Location

Pfizer Investigational Site

Bentonville, Arkansas, 72712, United States

Location

Pfizer Investigational Site

Fayetteville, Arkansas, 72703, United States

Location

Pfizer Investigational Site

Hudson, Florida, 34667, United States

Location

Pfizer Investigational Site

New Port Richey, Florida, 34655, United States

Location

Pfizer Investigational Site

Mahwah, New Jersey, 07430, United States

Location

Pfizer Investigational Site

Midland Park, New Jersey, 07432, United States

Location

Pfizer Investigational Site

Paramus, New Jersey, 07652, United States

Location

Pfizer Investigational Site

Westwood, New Jersey, 07675, United States

Location

Pfizer Investigational Site

Oneida, New York, 13421, United States

Location

Pfizer Investigational Site

Oswego, New York, 13126, United States

Location

Pfizer Investigational Site

Syracuse, New York, 13210-2306, United States

Location

Pfizer Investigational Site

Syracuse, New York, 13210, United States

Location

Pfizer Investigational Site

Sylvania, Ohio, 43560, United States

Location

Pfizer Investigational Site

Seattle, Washington, 89109, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98195, United States

Location

Pfizer Investigational Site

Großhansdorf, 22927, Germany

Location

Pfizer Investigational Site

Mannheim, 68167, Germany

Location

Pfizer Investigational Site

Torino, 10126, Italy

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PemetrexedProMune

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 3, 2006

Study Start

September 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

September 28, 2009

Record last verified: 2009-09

Locations

US(17)IT(1)DE(2)