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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Non-Small Cell Lung

Treatments: Drug: pemetrexed + PF-3512676; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00321308

A8501004

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

B

Active Comparator group

Description:

Standard of care chemotherapy

Treatment:

Drug: pemetrexed

A

Experimental group

Description:

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

Treatment:

Drug: pemetrexed + PF-3512676