Lung Cancer Clinical Trial

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

Summary

To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Advanced Non-Small Cell Lung Cancer (NSCLC).
For Cohort I and Cohort II, advanced NSCLC patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. To be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated.
For Cohort III, advanced NSCLC patients must not have received prior systemic treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2 mutation or HER-2 amplification. Cohort III patients could have received prior adjuvant chemotherapy for Stage I-III disease or combined modality chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed>12 months prior to enrollment.
All cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll.
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Estimated creatinine clearance ≥15 mL/min.

Exclusion Criteria:

Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).
Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts).
Patients with known diffuse interstitial lung disease (all cohorts).
Investigational therapy as only treatment for advanced NSCLC without administration of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

236

Study ID:

NCT01465802

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 67 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
St. Jude Heritage Healthcare
Fullerton California, 92835, United States
UCLA Hematology Oncology
Irvine California, 92604, United States
UC San Diego Medical Center - La Jolla
La Jolla California, 92037, United States
UC San Diego Moores Cancer Center - Investigational Drug Services
La Jolla California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles California, 90095, United States
Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D.
Los Angeles California, 90095, United States
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles California, 90095, United States
Drug Managment Only: UCLA West Medical Pharmacy
Los Angeles California, 90095, United States
Regulatory Management Only TRIO-US Central Administration
Los Angeles California, 90095, United States
Regulatory Management Only: TRIO-US Central Administration
Los Angeles California, 90095, United States
Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
UCLA Hematology Oncology
Los Angeles California, 90095, United States
Westwood Bowyer Clinic
Los Angeles California, 90095, United States
UCLA/Pasadena HealthCare
Pasadena California, 91105, United States
UC San Diego Medical Center - Hillcrest
San Diego California, 92103, United States
Coastal Integrative Cancer Care
San Luis Obispo California, 93401, United States
SANSUM Clinic
Santa Barbara California, 93105, United States
Cancer Center of Santa Barbara with SANSUM Clinic
Santa Barbara California, 93150, United States
Central Coast Medical Oncology Corporation
Santa Maria California, 93454, United States
UCLA Hematology Oncology
Santa Monica California, 90404, United States
UCLA Santa Monica Medical Center & Orthopaedic Hospital
Santa Monica California, 90404, United States
Cancer Center of Santa Barbara with SANSUM Clinic
Solvang California, 93463, United States
City of Hope South Pasadena Cancer Center
South Pasadena California, 91030, United States
UCLA/Santa Clarita Valley Cancer Center
Valencia California, 91355, United States
UCLA Cancer Center
Westlake Village California, 91361, United States
Kaiser Permanente Colorado - Franklin
Denver Colorado, 80205, United States
St. Mary's Hospital Regional Cancer Center
Grand Junction Colorado, 81501, United States
Kaiser Permanente Colorado - Rock Creek
Lafayette Colorado, 80026, United States
Kaiser Permanente Colorado - Lonetree
Lonetree Colorado, 80124, United States
Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Memorial Cancer Institute
Hollywood Florida, 33021, United States
Cancer Care of North Florida, PA
Lake City Florida, 32024, United States
Memorial West Cancer Institute
Pembroke Pines Florida, 33028, United States
University Cancer & Blood Center, LLC
Athens Georgia, 30607, United States
Summit Cancer Care,PC
Savannah Georgia, 31404, United States
Summit Cancer Care, PC
Savannah Georgia, 31405, United States
Rush University Medical Center, Division of Hematology & Oncology
Chicago Illinois, 60612, United States
Ships Drugs to: Emmanuel Semmes, RPh (or Ami Patel, Pharm D) University of Chicago
Chicago Illinois, 60637, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Illinois CancerCare, P.C.
Peoria Illinois, 61615, United States
Cancer Center of Kansas
Wichita Kansas, 67208, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Josephine Ford Cancer Center-Downriver
Brownstown Michigan, 48183, United States
Henry Ford Medical Center - Fairlane
Dearborn Michigan, 48126, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Henry Ford Medical Center - Columbus
Novi Michigan, 48377, United States
Henry Ford Hospital and Medical Center - West Bloomfield
West Bloomfield Michigan, 48322, United States
The West Clinic, PC
Corinth Mississippi, 38834, United States
The West Clinic, PC
Southaven Mississippi, 38671, United States
Mercy Clinic Cancer & Hematology-Branson
Branson Missouri, 65616, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
Mercy Clinic Cancer and Hematology - Chub O-Reilly Cancer Center
Springfield Missouri, 65807, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
Montefiore-Einstein Center for Cancer Care
Bronx New York, 10461, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Beth Israel Medical Center
New York New York, 10003, United States
Beth Israel Comprehensive Cancer Center
New York New York, 10011, United States
Columbia University Medical Center - The New York Presbyterian Hospital
New York New York, 10032, United States
Stony Brook University Medical Center-Cancer Center
Stony Brook New York, 11794, United States
Carolina Oncology Specialists, PA
Hickory North Carolina, 28602, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Legacy Pharma Research
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
St Alexius Medical Center
Bismarck North Dakota, 58501, United States
Charleston Hematology Oncology Associates, PA
Charleston South Carolina, 29414, United States
The West Clinic, PC
Memphis Tennessee, 38104, United States
The West Clinic, PC
Memphis Tennessee, 38120, United States
Investigational Product Center (IPC)
Fort Worth Texas, 76177, United States
Investigational Products Center (IPC)
Fort Worth Texas, 76177, United States
'Fletcher Allen Health Care, Inc
Burlington Vermont, 05401, United States
Office of Clinical Trials Research, Fletcher Allen Health Care, Inc.
Burlington Vermont, 05405, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Swedish Cancer Institute - Issaquah
Issaquah Washington, 98029, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Swedish Medical Center
Seattle Washington, 98122, United States
Seoul National University Hospital
Seoul , 110-7, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 120-7, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

236

Study ID:

NCT01465802

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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