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

• ClinicalTrials.gov Identifier: NCT00321308
• Recruitment Status: Terminated
• First Posted: May 3, 2006
• Last Update Posted: September 28, 2009
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: May 2, 2006
• First Posted Date: May 3, 2006
• Last Update Posted Date: September 28, 2009
• Study Start Date: September 2006
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2007): Progression-free survival [ Time Frame: 110 Events ]
• Original Primary Outcome Measures (submitted: May 2, 2006): Progression-free survival

Current Secondary Outcome Measures (submitted: December 21, 2007)

• Overall Survival [ Time Frame: Time of death ]
• Overall Safety Profile [ Time Frame: 28 days post treatment ]
• Patient Reported Outcome [ Time Frame: End of Treatment ]
• Time to Tumor Progression [ Time Frame: End of treatment ]
• Overall Objective Response Rate [ Time Frame: Time of disease progressive disease ]
• Duration of Response [ Time Frame: Time of disease progression ]

• Original Secondary Outcome Measures (submitted: May 2, 2006): Time to Tumor Progression Overall Objective Response Rate Duration of Response Overall Survival Overall Safety Profile Patient Reported Outcome Pharmacokinetic Parameters
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Non-Small Cell Lung

Intervention

• 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

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 11, 2008): 36
• Original Enrollment (submitted: May 2, 2006): 130
• Actual Study Completion Date: January 2008
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Italy, United States

Administrative Information

• NCT Number: NCT00321308
• Other Study ID Numbers: A8501004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: September 2009