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

Phase 2

Terminated

• Conditions: Carcinoma, Non-Small Cell Lung
• Interventions: Drug: pemetrexed + PF-3512676; Drug: pemetrexed

• Registration Number: NCT00321308
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2006-05-02
• Study First Submitted QC: 2006-05-02
• Study First Posted: 2006-05-03
• Study Start: 2006-09
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2009-09
• Disposition First Submitted: 2009-09-24
• Disposition First Submitted QC: 2009-09-24
• Last Update Submitted: 2009-09-24
• Disposition First Posted: 2009-09-28
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	pemetrexed + PF-3512676	Standard of care chemotherapy plus experimental intervention (PF-3512676)
B	pemetrexed	Standard of care chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression-free survival	110 Events

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Time of death
Duration of Response	Time of disease progression
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇹 Torino, Italy