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A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Non-Small-Cell Lung

Intervention: erlotinib (Drug); sunitinib (Drug); erlotinib (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen

Clinical Details

Official title: Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Progression-Free Survival (PFS)

Secondary outcome:

Percentage of Participants With Objective Response

Time to Tumor Progression (TTP)

Duration of Response (DR)

Overall Survival (OS)

Percentage of Participants Surviving at 1 Year

Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib

AUC(0-24) of Sunitinib

AUC(0-24) of SU-012662 (Metabolite of Sunitinib)

AUC(0-24) of Total Drug (Sunitinib + SU-012662)

Maximum Observed Plasma Concentration (Cmax) of Erlotinib

Cmax of Sunitinib

Cmax of SU-012662 (Metabolite of Sunitinib)

Cmax of Total Drug (Sunitinib + SU-012662)

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib

AUC(0-inf) for Sunitinib

AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)

AUC(0-inf) for Total Drug (Sunitinib + SU-012662)

Plasma Decay Half-life (t1/2) of Erlotinib

Plasma Decay Half-life (t1/2) of Sunitinib

Erlotinib Clearance at Steady State After Oral Administration (CL/F)

Sunitinib Clearance at Steady State After Oral Administration (CL/F)

Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib

Tmax for Sunitinib

Tmax for SU-012662 (Metabolite of Sunitinib)

Tmax for Total Drug (Sunitinib + SU-012662)

Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff

PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)

Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)

PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)

Percentage of Participants With EGFR Gene Copy Number Increase

PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase

Percentage of Participants With EGFR Gene Amplification

PFS in Subgroups That Were Defined by EGFR Gene Amplification

Percentage of Participants With EGFR Gene Mutation

PFS in Subgroups That Were Defined by EGFR Gene Mutation

Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations

PFS in Subgroups That Were Defined by KRAS Gene Mutation

Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms

PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms

PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

Percentage of Participants by Tumor VEGFR Mutation

Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts

Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile

PFS in Subgroups That Were Defined by RNA Expression Profile

Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score

EORTC-QLQ-C30 Lung Cancer Module (LC13) Score

Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)

Number of Participants With BP Greater Than 200/110 mmHg

Number of Participants on Anti-hypertensive Medications

Plasma Concentration of VEGF-C at Baseline

Plasma Concentration of Soluble VEGFR-2 at Baseline

Plasma Concentration of Soluble VEGFR-3 at Baseline

Plasma Concentration of Soluble KIT (sKIT) at Baseline

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with locally advanced/metastatic non-small cell lung cancer

- Prior treatment with no more than 2 chemotherapy regimens including a platinum-based

regimen Exclusion Criteria:

- Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial

growth factor (VEGF) inhibitors or other angiogenic inhibitors

- History of or known brain metastases

Locations and Contacts

Pfizer Investigational Site, Budapest 1525, Hungary

Pfizer Investigational Site, Torokbalint 2045, Hungary

Pfizer Investigational Site, Genova 16132, Italy

Pfizer Investigational Site, Monteforte Irpino, AV 83024, Italy

Pfizer Investigational Site, Amsterdam 1066 CX, Netherlands

Pfizer Investigational Site, Groningen 9713 GZ, Netherlands

Pfizer Investigational Site, Bydgoszcz 85-796, Poland

Pfizer Investigational Site, Gdansk 80-952, Poland

Pfizer Investigational Site, Bucuresti 30171, Romania

Pfizer Investigational Site, Birmingham, Alabama 35233, United States

Pfizer Investigational Site, Birmingham, Alabama 35294, United States

Pfizer Investigational Site, Mobile, Alabama 36604, United States

Pfizer Investigational Site, Edmonton, Alberta T6G 1Z2, Canada

Pfizer Investigational Site, Antioch, California 94531, United States

Pfizer Investigational Site, Palm Springs, California 92262-4885, United States

Pfizer Investigational Site, Pleasant Hill, California 94523, United States

Pfizer Investigational Site, San Leandro, California 94578, United States

Pfizer Investigational Site, Santander, Cantabria 39008, Spain

Pfizer Investigational Site, Cluj-Napoca, Cluj 400015, Romania

Pfizer Investigational Site, Chicago, Illinois 60612, United States

Pfizer Investigational Site, Creve Coeur, Missouri 63141, United States

Pfizer Investigational Site, St. Louis, Missouri 63110-1094, United States

Pfizer Investigational Site, St. Louis, Missouri 63110, United States

Pfizer Investigational Site, St. Peters, Missouri 63376, United States

Pfizer Investigational Site, Chapel Hill, North Carolina 27599-7600, United States

Pfizer Investigational Site, Clinton, North Carolina 28328, United States

Pfizer Investigational Site, Goldsboro, North Carolina 27534, United States

Pfizer Investigational Site, Wilson, North Carolina 27893, United States

Pfizer Investigational Site, Cleveland, Ohio 44106, United States

Pfizer Investigational Site, Hamilton, Ontario L8V 5C2, Canada

Pfizer Investigational Site, Bucuresti, Sector 2 022328, Romania

Pfizer Investigational Site, Houston, Texas 77030, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2006
Last updated: January 31, 2013

Page last updated: August 23, 2015

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