Clinical trial 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
Official title: ARCHER 1042: A PHASE 2 STUDY OF DACOMITINIB IN ADVANCED NON-SMALL CELL LUNG CANCER (POST-CHEMOTHERAPY OR SELECT FIRST LINE PATIENTS) TO EVALUATE PROPHYLACTIC INTERVENTION ON DERMATOLOGIC AND GASTROINTESTINAL ADVERSE EVENTS AND PATIENT REPORTED OUTCOMES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer (NSCLC)
Keywords: non-small cell lung cancer
advanced
previously treated
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-06
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief 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).


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)

Primary outcomes:
measure: Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I
timeFrame: First 8 Weeks of Treatment
measure: Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I
timeFrame: First 8 Weeks of Treatment
measure: Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I
timeFrame: First 8 Weeks of Treatment
measure: Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II
timeFrame: First 8 Weeks of Treatment
measure: Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II
timeFrame: Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up
measure: Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II
timeFrame: First 8 Weeks of Treatment
measure: Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II
timeFrame: First 8 Weeks of Treatment
measure: Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II
timeFrame: Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up
measure: Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III
timeFrame: Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
measure: Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III
timeFrame: Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
measure: Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III
timeFrame: Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
Secondary outcomes:
measure: Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III
timeFrame: Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)
measure: Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I
timeFrame: Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
measure: Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I
timeFrame: Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
measure: Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I
timeFrame: Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
measure: Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I
timeFrame: Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
measure: Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III
timeFrame: Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.
measure: Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III
timeFrame: Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare
state: California
city: Irvine
country: United States
facility: UCLA Hematology Oncology
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center - La Jolla
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center - Investigational Drug Services
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Drug Management Only: UCLA West Medical Pharmacy
state: California
city: Los Angeles
country: United States
facility: Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D.
state: California
city: Los Angeles
country: United States
facility: Drug Management Only: UCLA West Medical Pharmacy
state: California
city: Los Angeles
country: United States
facility: Drug Managment Only: UCLA West Medical Pharmacy
state: California
city: Los Angeles
country: United States
facility: Regulatory Management Only TRIO-US Central Administration
state: California
city: Los Angeles
country: United States
facility: Regulatory Management Only: TRIO-US Central Administration
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology Oncology
state: California
city: Los Angeles
country: United States
facility: Westwood Bowyer Clinic
state: California
city: Pasadena
country: United States
facility: UCLA/Pasadena HealthCare
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center - Hillcrest
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Santa Barbara
country: United States
facility: SANSUM Clinic
state: California
city: Santa Barbara
country: United States
facility: Cancer Center of Santa Barbara with SANSUM Clinic
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology
state: California
city: Santa Monica
country: United States
facility: UCLA Santa Monica Medical Center & Orthopaedic Hospital
state: California
city: Solvang
country: United States
facility: Cancer Center of Santa Barbara with SANSUM Clinic
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena Cancer Center
state: California
city: Valencia
country: United States
facility: UCLA/Santa Clarita Valley Cancer Center
state: California
city: Westlake Village
country: United States
facility: UCLA Cancer Center
state: California
city: Denver
country: United States
facility: Kaiser Permanente Colorado - Franklin
state: Colorado
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Cancer Center
state: Colorado
city: Lafayette
country: United States
facility: Kaiser Permanente Colorado - Rock Creek
state: Colorado
city: Lonetree
country: United States
facility: Kaiser Permanente Colorado - Lonetree
state: Colorado
city: Fort Lauderdale
country: United States
facility: Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Lake City
country: United States
facility: Cancer Care of North Florida, PA
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial West Cancer Institute
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Care,PC
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Care, PC
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center, Division of Hematology & Oncology
state: Illinois
city: Chicago
country: United States
facility: Ships Drugs to: Emmanuel Semmes, RPh (or Ami Patel, Pharm D) University of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare, P.C.
state: Illinois
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Brownstown
country: United States
facility: Josephine Ford Cancer Center-Downriver
state: Michigan
city: Dearborn
country: United States
facility: Henry Ford Medical Center - Fairlane
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Novi
country: United States
facility: Henry Ford Medical Center - Columbus
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Hospital and Medical Center - West Bloomfield
state: Michigan
city: Corinth
country: United States
facility: The West Clinic, PC
state: Mississippi
city: Southaven
country: United States
facility: The West Clinic, PC
state: Mississippi
city: Branson
country: United States
facility: Mercy Clinic Cancer & Hematology-Branson
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Cancer and Hematology - Chub O-Reilly Cancer Center
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore-Einstein Center for Cancer Care
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - The New York Presbyterian Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center-Cancer Center
state: New York
city: Hickory
country: United States
facility: Carolina Oncology Specialists, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Bismarck
country: United States
facility: Legacy Pharma Research
state: North Dakota
city: Bismarck
country: United States
facility: Mid Dakota Clinic, PC
state: North Dakota
city: Bismarck
country: United States
facility: St Alexius Medical Center
state: North Dakota
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Memphis
country: United States
facility: The West Clinic, PC
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic, PC
state: Tennessee
city: Fort Worth
country: United States
facility: Investigational Product Center (IPC)
state: Texas
city: Fort Worth
country: United States
facility: Investigational Products Center (IPC)
state: Texas
city: Burlington
country: United States
facility: 'Fletcher Allen Health Care, Inc
state: Vermont
city: Burlington
country: United States
facility: Office of Clinical Trials Research, Fletcher Allen Health Care, Inc.
state: Vermont
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Issaquah
country: United States
facility: Swedish Cancer Institute - Issaquah
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: