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NCT00313768 Clinical Trial

Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00313768
Other study ID # A8501003
Secondary ID
Status Terminated
Phase Phase 2
First received April 10, 2006
Last updated September 24, 2009
Start date December 2005
Est. completion date May 2008

Study information
Verified date September 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer

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/survival follow-up. Data collection was completed on 22 May 2008.

Recruitment information / eligibility
Status Terminated
Enrollment 23
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Advanced Stage IIIb with pleural effusion or Stage IV nonsquamous non-small cell lung cancer

- ECOG Performance Status 0-1

- Measurable disease per RECIST criteria

Exclusion Criteria:

- Squamous cell, small cell, or carcinoid lung cancer

- CNS metastasis

- Pre-existing autoimmune or antibody mediated disease

- Prior systemic treatment for NSCLC with chemo, immunotherapy, biologics, or investigation drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• paclitaxel + carboplatin + bevacizumab
paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles
• carboplatin + paclitaxel + bevacizumab + PF-3512676
carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles

Locations
Country Name City State
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Bessemer Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Clinton North Carolina
United States Pfizer Investigational Site Cocoa Beach Florida
United States Pfizer Investigational Site Fountain Valley California
United States Pfizer Investigational Site Georgetown Texas
United States Pfizer Investigational Site Goldsboro North Carolina
United States Pfizer Investigational Site Joliet Illinois
United States Pfizer Investigational Site Joliet Illinois
United States Pfizer Investigational Site Knoxville Tennessee
United States Pfizer Investigational Site Knoxville Tennessee
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Merritt Island Florida
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Pollocksville North Carolina
United States Pfizer Investigational Site Rockledge Florida
United States Pfizer Investigational Site San Marcos Texas
United States Pfizer Investigational Site Titusville Florida
United States Pfizer Investigational Site Valdosta Georgia
United States Pfizer Investigational Site Wilson North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival 110 Events No
Secondary Time to Tumor Progression End of treatment No
Secondary Overall Objective Response Rate Time of progressive disease No
Secondary Duration of Response Time of progression No
Secondary Overall Survival Time of death No
Secondary Overall safety profile 28 days post treatment Yes
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Completed NCT04427072 - Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation Phase 3
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A

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