A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

NCT00769067 | Completed Phase 2 Results

• 2 other identifiers: A74710282008-005235-14
• Study Type: interventional
• Target: 188
• Locations: 12 countries
• Sites: 59

Brief Summary

This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

Conditions

Non-small Cell Lung Cancer

Keywords

Lung cancer; advanced; second or third line

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date \[if the event date unavailable\] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

  Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks

Secondary Outcomes (7)

• Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

  Baseline up to Cycle 44 (Week 188)

• Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)

  Baseline up to Cycle 44 (Week 188)

• Dermatology Life Quality Index (DLQI)

  Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44

• Percentage of Participants With Objective Response

  Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks

• Best Overall Response (BOR)

  Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks

Other Outcomes (3)

• Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation

  Baseline

• Soluble Protein Biomarkers Level

  Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)

• Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)

  C1D10-14, C2D1, C3D1, C4D1

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Erlotinib

B

EXPERIMENTAL

Drug: PF-00299804

Interventions

Erlotinib DRUG

Continuous oral dosing at 150 mg daily.

A

PF-00299804 DRUG

Continuous oral dosing at 45mg daily

B

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• advanced measurable Non-Small Cell Lung Cancer (NSCLC);
• progressed after 1-2 prior chemotherapy;
• Eastern Cooperative Oncology Group (ECOG) 0-2;
• tissue available for future KRAS/ EGFR testing

You may not qualify if:

• prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
• active or untreated Central Nervous System (CNS) metastases;

Sponsors & Collaborators

• Pfizer: lead

Study Sites (59)

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, 35661, United States

Location

Agajanian Institute of Oncology and Hematology

Montebello, California, 90640, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Wittingham Cancer Center @ Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Medical Oncology & Hematology, P.C.

Waterbury, Connecticut, 06708, United States

Location

Winship Cancer Institute at Grady Health Systems

Atlanta, Georgia, 30303, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322-1013, United States

Location

Winship Cancer Institute at Emory University

Atlanta, Georgia, 30322, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Augusta Oncology Associates, P.C.

Augusta, Georgia, 30901, United States

Location

Augusta Oncology Associates, PC

Augusta, Georgia, 30909, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Georgia Cancer Specialists

Decatur, Georgia, 30033, United States

Location

The Longstreet Cancer Center

Gainesville, Georgia, 30501, United States

Location

Central Georgia Cancer Care, P.C.

Macon, Georgia, 31201, United States

Location

Northwest Georgia Oncology Center

Marietta, Georgia, 30106, United States

Location

Central Georgia Cancer Care, P.C.

Warner Robins, Georgia, 31088-2259, United States

Location

Kootenai Cancer Center at Post Falls

Post Falls, Idaho, 83854, United States

Location

Kootenai Cancer Center

Post Falls, Idaho, 83854, United States

Location

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

Center for Blood and Cancer Disorders

Bethesda, Maryland, 20817, United States

Location

Associates in Oncology/Hematology, PC

Rockville, Maryland, 20850, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Oncology/Hematology Associates

Clarksburg, West Virginia, 26301, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

The Andrew Love Cancer Centre,

Geelong, Victoria, 3220, Australia

Location

Border Medical Oncology

Wodonga, Victoria, 3690, Australia

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Hospital Sao Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

FUNDACAO PIO XII Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Department of Clinical Oncology

Shatin, New Territories, Hong Kong

Location

Department of Clinical Oncology, Tuen Mun Hospital

Tuenmen, New Territories, Hong Kong

Location

Medex spolka cywilna

Chrzanów, 32-500, Poland

Location

¿KardioDent¿

Krakow, 30-045, Poland

Location

"Vesalius" Sp. z o.o.

Krakow, 31-108, Poland

Location

Zaklad Rentgena i USG Wyrobek spolka jawna

Krakow, 31-215, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej AVI Centrum Medyczne

Warsaw, 00-728, Poland

Location

Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Ponce School of Medicine / CAIMED Center

Ponce, PR, 00716, Puerto Rico

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center

Seoul, 120-752, South Korea

Location

SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine

Seoul, 135-710, South Korea

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Teresa Herrera

A Coruña, La Coruña, 15006, Spain

Location

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital, Chest Department

Taipei, 112, Taiwan

Location

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (1)

• Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13.

  PMID: 26768165 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasm Metastasis

Interventions

Erlotinib Hydrochloride; dacomitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2014
• Last Updated: October 7, 2015
• Results First Posted: August 21, 2015

Record last verified: 2015-09

Locations

US (26); BR (4); AU (4); HK (2); PL (6); KR (3); TW (2); GB (2); SG (1); ES (4); PR (1); CA (4)