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 (ARCHER 1042)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01465802
First received: October 20, 2011
Last updated: December 14, 2015
Last verified: December 2015
  Purpose
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).

Condition Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Drug: Dacomitinib Plus Blinded Doxycycline or Placebo
Drug: Dacomitinib Plus Probiotic Plus Topical Alclometasone cream
Drug: Dacomitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Cohort I: Incidence of all-causality, all grade and grade ≥2 select dermatologic adverse events of interest (SDAEI) in the first 8 weeks of treatment by arm. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Cohort II: Incidence of all-causality, all grade and grade ≥2 diarrhea adverse events in the first 8 weeks of treatment. Incidence of all-causality, all grade and grade ≥2 select dermatologic adverse events of interest (SDAEI) in [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  • the first 8 weeks of treatment by arm. [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  • Cohort I:Skindex-16 Scale scores (Total score, Symptoms score, Emotions score, Functioning score) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cohort II: Mucositis Daily Questionaire (diarrhea questions) Skindex-16 Scale scores (Total score, Symptoms score, Emotions score, Functioning score) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Cohort III: Pharmacokinetics of PF-00299804 and PF-05199265 metabolite Cohort 3 primary PK endpoints include: Parent and metabolite: AUC0-120, AUC0-24, Cmax, Tmax [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall safety profile as characterized by type, frequency, severity of adverse events as graded by NCI CTCAE.v4, timing and relationship to treatment on each arm, laboratory abnormalities observed, and left ventricular imaging observed. [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
  • Concomitant medication (both prescribed and non-prescription) used for dermatologic AEs of interest, diarrhea, and mucositis. [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Trough concentrations (Ctrough) of PF-00299804 and PF-05199265, as determined from trough plasma samples. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Enrollment: 236
Study Start Date: December 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort I
Cohort I is a dermatologic intervention cohort that will randomize to 2 separate arms (blinded doxycycline placebo; blinded doxycycline)
Drug: Dacomitinib Plus Blinded Doxycycline or Placebo
Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent PLUS doxycycline or doxycycline placebo BID for 4 weeks
Experimental: Cohort II
Cohort II is a single arm with dacomitinib 45 mg daily PLUS probiotic PLUS topical alclometasone
Drug: Dacomitinib Plus Probiotic Plus Topical Alclometasone cream
Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent PLUS Probiotic PLUS topical Alclometasone cream
Experimental: Cohort III
Cohort III is an interrupted dosing schedule of dacomitinib in the first cycle only
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465802

  Hide Study Locations
Locations
United States, California
City of Hope
Duarte, California, United States, 91010
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
UCLA Hematology Oncology
Irvine, California, United States, 92604
UC San Diego Medical Center - La Jolla
La Jolla, California, United States, 92037
UC San Diego Moores Cancer Center - Investigational Drug Services
La Jolla, California, United States, 92037
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095
Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D.
Los Angeles, California, United States, 90095
Westwood Bowyer Clinic
Los Angeles, California, United States, 90095
Drug Managment Only: UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095
Regulatory Management Only TRIO-US Central Administration
Los Angeles, California, United States, 90095
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-7349
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
UCLA Hematology Oncology
Los Angeles, California, United States, 90095
Regulatory Management Only: TRIO-US Central Administration
Los Angeles, California, United States, 90095
UCLA/Pasadena HealthCare
Pasadena, California, United States, 91105
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Cancer Center of Santa Barbara with SANSUM Clinic
Santa Barbara, California, United States, 93150
SANSUM Clinic
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
UCLA Hematology Oncology
Santa Monica, California, United States, 90404
UCLA Santa Monica Medical Center & Orthopaedic Hospital
Santa Monica, California, United States, 90404
Cancer Center of Santa Barbara with SANSUM Clinic
Solvang, California, United States, 93463
City of Hope South Pasadena Cancer Center
South Pasadena, California, United States, 91030
UCLA/Santa Clarita Valley Cancer Center
Valencia, California, United States, 91355
UCLA Cancer Center
Westlake Village, California, United States, 91361
United States, Colorado
Kaiser Permanente Colorado - Franklin
Denver, Colorado, United States, 80205
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States, 81501
Kaiser Permanente Colorado - Rock Creek
Lafayette, Colorado, United States, 80026
Kaiser Permanente Colorado - Lonetree
Lonetree, Colorado, United States, 80124
United States, Florida
Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
Ft. Lauderdale, Florida, United States, 33308
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Memorial Hospital West (drug shipment only)
Hollywood, Florida, United States, 33021
Cancer Care of North Florida, PA
Lake City, Florida, United States, 32024
Memorial Hospital West (drug shipment only)
Pembroke Pines, Florida, United States, 33028
Memorial West Cancer Institute
Pembroke Pines, Florida, United States, 33028
United States, Georgia
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
Summit Cancer Care,PC
Savannah, Georgia, United States, 31404
Summit Cancer Care, PC
Savannah, Georgia, United States, 31405
United States, Illinois
Ships Drugs to: Emmanuel Semmes, RPh (or Ami Patel, Pharm D) University of Chicago
Chicago, Illinois, United States, 60637
Rush University Medical Center, Division of Hematology & Oncology
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Illinois CancerCare, P.C.
Peoria, Illinois, United States, 61615
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
Cancer Center of Kansas
Wichita, Kansas, United States, 67208
United States, Michigan
Josephine Ford Cancer Center-Downriver
Brownstown, Michigan, United States, 48183
Henry Ford Medical Center - Fairlane
Dearborn, Michigan, United States, 48126
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Henry Ford Medical Center - Columbus
Novi, Michigan, United States, 48377
Henry Ford Hospital and Medical Center - West Bloomfield
West Bloomfield, Michigan, United States, 48322
United States, Mississippi
The West Clinic, PC
Corinth, Mississippi, United States, 38834
The West Clinic, PC
Southaven, Mississippi, United States, 38671
United States, Missouri
Mercy Clinic Cancer & Hematology-Branson
Branson, Missouri, United States, 65616
Mercy Clinic Cancer and Hematology - Chub O-Reilly Cancer Center
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Montefiore-Einstein Center for Cancer Care
Bronx, New York, United States, 10461
Montefiore Medical Center
Bronx, New York, United States, 10467
IP Shipment: CUMC Research Pharmacy
New York, New York, United States, 10032
Beth Israel Comprehensive Cancer Center
New York, New York, United States, 10011
Columbia University Medical Center - The New York Presbyterian Hospital
New York, New York, United States, 10032
Beth Israel Medical Center
New York,, New York, United States, 10003
Stony Brook University Medical Center-Cancer Center
Stony Brook, New York, United States, 11794-9447
United States, North Carolina
Carolina Oncology Specialists, PA
Hickory, North Carolina, United States, 28602
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Legacy Pharma Research
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
St Alexius Medical Center
Bismarck, North Dakota, United States, 58501
United States, South Carolina
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States, 29414
United States, Tennessee
The West Clinic, PC
Memphis, Tennessee, United States, 38120
The West Clinic, PC
Memphis, Tennessee, United States, 38104
United States, Texas
Investigational Product Center (IPC)
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC) (drug shipment only)
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC)
Fort Worth, Texas, United States, 76177
United States, Vermont
'Fletcher Allen Health Care, Inc
Burlington, Vermont, United States, 05401
Office of Clinical Trials Research, Fletcher Allen Health Care, Inc.
Burlington, Vermont, United States, 05405
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
United States, Washington
Drug Shipment Address: Lisa Nakatsu, RPh, Investigational Drug Service
Issaquah, Washington, United States, 98122
Swedish Cancer Institute - Issaquah
Issaquah, Washington, United States, 98029
Drug Shipment Address: Joshua Mark, RPh, Invesligational Drug Service
Issaquah, Washington, United States, 98029
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98122
Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01465802     History of Changes
Other Study ID Numbers: A7471042 
Study First Received: October 20, 2011
Last Updated: December 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
non-small cell lung cancer
advanced
previously treated

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Alclometasone dipropionate
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 07, 2016