Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO

PHASE2CompletedINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

December 26, 2011

Primary Completion Date

May 18, 2015

Study Completion Date

May 18, 2015

Conditions
Non Small Cell Lung Cancer (NSCLC)
Interventions
DRUG

Dacomitinib

Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent

DRUG

Dacomitinib

Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent

DRUG

Doxycycline

Doxycycline or Doxycycline placebo BID for 4 weeks

DRUG

Probiotic

VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28)

DRUG

Alclometasone cream

Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks

Trial Locations (81)

10003

Beth Israel Medical Center, New York

10011

Beth Israel Comprehensive Cancer Center, New York

10032

Columbia University Medical Center - The New York Presbyterian Hospital, New York

10461

Montefiore-Einstein Center for Cancer Care, The Bronx

10467

Montefiore Medical Center, The Bronx

22031

Virginia Cancer Specialists, PC, Fairfax

27157

Wake Forest University Health Sciences, Winston-Salem

28602

Carolina Oncology Specialists, PA, Hickory

29414

Charleston Hematology Oncology Associates, PA, Charleston

30607

University Cancer & Blood Center, LLC, Athens

31404

Summit Cancer Care,PC, Savannah

31405

Summit Cancer Care, PC, Savannah

32024

Cancer Care of North Florida, PA, Lake City

33021

Memorial Cancer Institute, Hollywood

33028

Memorial West Cancer Institute, Pembroke Pines

33308

Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital, Fort Lauderdale

38104

The West Clinic, PC, Memphis

38120

The West Clinic, PC, Memphis

38671

The West Clinic, PC, Southaven

38834

The West Clinic, PC, Corinth

48126

Henry Ford Medical Center - Fairlane, Dearborn

48183

Josephine Ford Cancer Center-Downriver, Brownstown

48202

Henry Ford Hospital, Detroit

48322

Henry Ford Hospital and Medical Center - West Bloomfield, West Bloomfield

48377

Henry Ford Medical Center - Columbus, Novi

58501

Legacy Pharma Research, Bismarck

Mid Dakota Clinic, PC, Bismarck

St Alexius Medical Center, Bismarck

60612

Rush University Medical Center, Division of Hematology & Oncology, Chicago

60637

Ships Drugs to: Emmanuel Semmes, RPh (or Ami Patel, Pharm D) University of Chicago, Chicago

University of Chicago Medical Center, Chicago

61615

Illinois CancerCare, P.C., Peoria

65616

Mercy Clinic Cancer & Hematology-Branson, Branson

65804

Mercy Hospital Springfield, Springfield

65807

Mercy Clinic Cancer and Hematology - Chub O-Reilly Cancer Center, Springfield

67208

Cancer Center of Kansas, Wichita

67214

Cancer Center of Kansas, Wichita

76177

Investigational Product Center (IPC), Fort Worth

Investigational Products Center (IPC), Fort Worth

80026

Kaiser Permanente Colorado - Rock Creek, Lafayette

80124

Kaiser Permanente Colorado - Lonetree, Lonetree

80205

Kaiser Permanente Colorado - Franklin, Denver

81501

St. Mary's Hospital Regional Cancer Center, Grand Junction

89128

Comprehensive Cancer Centers of Nevada, Las Vegas

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90095

Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D., Los Angeles

Drug Management Only: UCLA West Medical Pharmacy, Los Angeles

Drug Managment Only: UCLA West Medical Pharmacy, Los Angeles

Regulatory Management Only TRIO-US Central Administration, Los Angeles

Regulatory Management Only: TRIO-US Central Administration, Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles

UCLA Hematology Oncology, Los Angeles

Westwood Bowyer Clinic, Los Angeles

90404

UCLA Hematology Oncology, Santa Monica

UCLA Santa Monica Medical Center & Orthopaedic Hospital, Santa Monica

91010

City of Hope, Duarte

91030

City of Hope South Pasadena Cancer Center, South Pasadena

91105

UCLA/Pasadena HealthCare, Pasadena

91355

UCLA/Santa Clarita Valley Cancer Center, Valencia

91361

UCLA Cancer Center, Westlake Village

92037

UC San Diego Medical Center - La Jolla, La Jolla

UC San Diego Moores Cancer Center - Investigational Drug Services, La Jolla

92093

UC San Diego Moores Cancer Center, La Jolla

92103

UC San Diego Medical Center - Hillcrest, San Diego

92604

UCLA Hematology Oncology, Irvine

92835

St. Jude Heritage Healthcare, Fullerton

93105

SANSUM Clinic, Santa Barbara

93150

Cancer Center of Santa Barbara with SANSUM Clinic, Santa Barbara

93401

Coastal Integrative Cancer Care, San Luis Obispo

93454

Central Coast Medical Oncology Corporation, Santa Maria

93463

Cancer Center of Santa Barbara with SANSUM Clinic, Solvang

98029

Swedish Cancer Institute - Issaquah, Issaquah

98104

Swedish Cancer Institute, Seattle

98122

Swedish Medical Center, Seattle

90095-7349

Drug Management Only: UCLA West Medical Pharmacy, Los Angeles

07039

Saint Barnabas Medical Center, Livingston

11794-9447

Stony Brook University Medical Center-Cancer Center, Stony Brook

05401

'Fletcher Allen Health Care, Inc, Burlington

05405

Office of Clinical Trials Research, Fletcher Allen Health Care, Inc., Burlington

110-744

Seoul National University Hospital, Seoul

120-752

Severance Hospital, Yonsei University Health System, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01465802 - Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO | Biotech Hunter | Biotech Hunter