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 is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01465802
First received: October 20, 2011
Last updated: April 8, 2015
Last verified: April 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 ]

Estimated Enrollment: 184
Study Start Date: December 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
University Of Colorado Active, not recruiting
Aurora, California, United States, 80045
City of Hope Active, not recruiting
Duarte, California, United States, 91010
St. Jude Heritage Healthcare - Virginia K. Crosson Cancer Center Active, not recruiting
Fullerton, California, United States, 92835
UCLA Hematology Oncology Active, not recruiting
Irvine, California, United States, 92604
UC San Diego Moores Cancer Center - Investigational Drug Services Active, not recruiting
La Jolla, California, United States, 92037
UC San Diego Medical Center - La Jolla Active, not recruiting
La Jolla, California, United States, 92037
Moores UC San Diego Cancer Center Clinical Trials Active, not recruiting
La Jolla, California, United States, 92093-0698
Westwood Bowyer Clinic Active, not recruiting
Los Angeles, California, United States, 90095
Drug Management Only: UCLA West Medical Pharmacy Active, not recruiting
Los Angeles, California, United States, 90095-1772
Drug Management Only: UCLA West Medical Pharmacy Active, not recruiting
Los Angeles, California, United States, 90095
Drug Management Only: UCLA West Modical Pharmacy Active, not recruiting
Los Angeles, California, United States, 90095
Drug Managment Only: UCLA West Medical Pharmacy Active, not recruiting
Los Angeles, California, United States, 90095
Regulatory Management Only TRIO-US Central Administration Active, not recruiting
Los Angeles, California, United States, 90095
Regulatoty Management Only: TRIO-US Central Administration Active, not recruiting
Los Angeles, California, United States, 90095
Ronald Reagan UCLA Medical Center - Drug Information Center Active, not recruiting
Los Angeles, California, United States, 90095
UCLA Hematology Oncology Active, not recruiting
Los Angeles, California, United States, 90095
Regulatory Management Only: TRIO-US Central Administration Active, not recruiting
Los Angeles, California, United States, 90095
UCLA/Pasadena HealthCare Active, not recruiting
Pasadenax, California, United States, 91105
Radiology Associates of San Luis Obispo Active, not recruiting
Prismo Beach, California, United States, 93449
UC San Diego Medical Center - Hillcrest Active, not recruiting
San Diego, California, United States, 92103
Coastal Integrative Cancer Care Active, not recruiting
San Luis Obispo, California, United States, 93401
Cancer Center of Santa Barbara with SANSUM Clinic Active, not recruiting
Santa Barbara, California, United States, 93105
SANSUM Clinic Active, not recruiting
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation Active, not recruiting
Santa Maria, California, United States, 93454
UCLA Hematology Oncology Active, not recruiting
Santa Monica, California, United States, 90404
UCLA Santa Monica Medical Center & Orthopaedic Hospital Active, not recruiting
Santa Monica, California, United States, 90404
Cancer Center of Santa Barbara with SANSUM Clinic Active, not recruiting
Solvang, California, United States, 93463
City of Hope South Pasadena Cancer Center Active, not recruiting
South Pasadena, California, United States, 91030
UCLA/Santa Clarita Valley Cancer Center Active, not recruiting
Valencia, California, United States, 91355
UCLA Cancer Center Active, not recruiting
Westlake Village, California, United States, 91361
United States, Colorado
St. Mary's Hospital Regional Cancer Center Active, not recruiting
Grand Junction, Colorado, United States, 81501
Kaiser Permanente Colorado-Rock Creek Active, not recruiting
Lafayette, Colorado, United States, 80026
Kaiser Permanente Colorado - Lonetree Active, not recruiting
Lonetree, Colorado, United States, 80124
United States, Florida
Michael and Dianne Bienes Cancer Center, Holy Cross Hospital Active, not recruiting
Fort Lauderdale, Florida, United States, 33308
Memorial Cancer Institute Active, not recruiting
Hollywood, Florida, United States, 33021
Cancer Care of North Florida, PA Active, not recruiting
Lake City, Florida, United States, 32024
Memorial Hospital West Active, not recruiting
Pembroke Pines, Florida, United States, 33028
Memorial West Cancer Institute Active, not recruiting
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Northeast Georgia Cancer Care, LLC Active, not recruiting
Athens, Georgia, United States, 30607
Summit Cancer Care, P.C., Active, not recruiting
Savannah, Georgia, United States, 31405
Summit Cancer Care, P.C., Active, not recruiting
Savannah, Georgia, United States, 31404
Solstas Lab Partners Active, not recruiting
Valdosta, Georgia, United States, 31602
United States, Illinois
University of Chicago Medical Center - Drug Shipment Only Active, not recruiting
Chicago, Illinois, United States, 60637
Rush University Medical Center Active, not recruiting
Chicago, Illinois, United States, 60612
Rush University Medical Center, Division of Hematology & Oncology Active, not recruiting
Chicago, Illinois, United States, 60612
The University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
The University of Chicago Medical Center Active, not recruiting
Chicago, Illinois, United States, 60637-1447
The University of Chicago Medical Center (UCMC) Active, not recruiting
Chicago, Illinois, United States, 60637-1426
Illinois CancerCare, P.C. Active, not recruiting
Peoria, Illinois, United States, 61615
United States, Kansas
Cancer Center of Kansas Active, not recruiting
Chanute, Kansas, United States, 66720
Cancer Center of Kansas Active, not recruiting
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas Active, not recruiting
Wichita, Kansas, United States, 67208
Cancer Center of Kansas Active, not recruiting
Wichita, Kansas, United States, 67214
Cancer Center of Kansas Active, not recruiting
Winfield, Kansas, United States, 67156
United States, Michigan
Josephine Ford Cancer Center-Downriver Active, not recruiting
Brownstown, Michigan, United States, 48183
Henry Ford Medical Center - Fairlane Active, not recruiting
Dearborn, Michigan, United States, 48126
Henry Ford Health Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
Henry Ford Medical Center - Columbus Center Active, not recruiting
Novi, Michigan, United States, 48377
Henry Ford Medical Center - West Bloomfield Active, not recruiting
W. Bloomfield, Michigan, United States, 48322
United States, Mississippi
The West Clinic, PC - Corinth Active, not recruiting
Corinth, Mississippi, United States, 38834
The West Clinic, PC - Southaven Active, not recruiting
Southaven, Mississippi, United States, 38671
United States, Missouri
Mercy Clinic Cancer & Hematology- Chub O-Reilly Cancer Center Active, not recruiting
Springfield, Missouri, United States, 65807
Mercy Medical Research Institute Active, not recruiting
Springfield, Missouri, United States, 65807
St. John's Medical Research Institute, Inc. Active, not recruiting
Springfield, Missouri, United States, 65807
United States, Nevada
Comprehensive Cancer Centers of Nevada Active, not recruiting
Henderson, Nevada, United States, 89014
Comprehensive Cancer Centers of Nevada - Sunset Rd. Active, not recruiting
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada - Peak Dr. Active, not recruiting
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Saint Barnabas Medical Center Active, not recruiting
Livingston, New Jersey, United States, 07039
United States, New York
Montefiore Medical Center Active, not recruiting
Bronx, New York, United States, 10467
Montefiore-Einstein Center for Cancer Care Active, not recruiting
Bronx, New York, United States, 10461
New York Presbytarian Hospital,Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Beth Israel Comprehensive Cancer Center Active, not recruiting
New York, New York, United States, 10011
New York Presbytarian Hospital,Columbia University Medical Center Active, not recruiting
New York City, New York, United States, 10032
Beth Israel Medical Center Active, not recruiting
New York,, New York, United States, 10003
Stony Brook University Medical Center Cancer Center Active, not recruiting
Stony Brook, New York, United States, 11794-9447
United States, North Carolina
Carolina Oncology Specialists PA Active, not recruiting
Hickory, North Carolina, United States, 28602
Carolina Oncology Specialists, PA Active, not recruiting
Hickory, North Carolina, United States, 28602
Wake Forest University Health Services Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Legacy Pharma Research Active, not recruiting
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic Active, not recruiting
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC Active, not recruiting
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Active, not recruiting
Bismarck, North Dakota, United States, 58501
United States, South Carolina
Charleston Hematology Oncology Associates, PA Active, not recruiting
Charleston, South Carolina, United States, 29414
United States, Tennessee
The West Clinic, PC Active, not recruiting
Memphis, Tennessee, United States, 38120
The West Clinic, PC - Memphis Active, not recruiting
Memphis, Tennessee, United States, 38104
United States, Texas
Investigational Product Center (IPC) Active, not recruiting
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC) (drug shipment only) Active, not recruiting
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC) (drug shipment only) Recruiting
Fort Worth, Texas, United States, 76177
United States, Vermont
Fletcher Allen Health Care, Inc. Active, not recruiting
Burlington, Vermont, United States, 05401
Office of Clinical Trials Research, Fletcher Allen Health Care, Inc. Active, not recruiting
Burlington, Vermont, United States, 05405
United States, Virginia
Arlington-Fairfax Hematology Oncology P.C. Recruiting
Arlington, Virginia, United States, 22205
Virginia Cancer Specialists, PC Recruiting
Arlington, Virginia, United States, 22205
Arlington Fairfax Hematology Oncology Recruiting
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC Recruiting
Gainesville, Virginia, United States, 20155
Virginia Cancer Specialists, PC Recruiting
Leesburg, Virginia, United States, 20176
Virginia Cancer Specialists Recruiting
Virginia, Virginia, United States, 22205
Virginia Cancer Specialists, PC Recruiting
Winchester, Virginia, United States, 22601
Virginia Cancer Specialists, PC Recruiting
Woodbridge, Virginia, United States, 22191
United States, Washington
Investigational Drug Services Active, not recruiting
Issaquah, Washington, United States, 98029
Swedish Cancer Institute Issaquah Active, not recruiting
Issaquah, Washington, United States, 98029
Swedish Cancer Institute Issaquah Campus Active, not recruiting
Issaquah, Washington, United States, 98029
Investigational Drug Services Active, not recruiting
Seattle, Washington, United States, 98122
Swedish Cancer Institute Active, not recruiting
Seattle, Washington, United States, 98104
Swedish Medial Center Active, not recruiting
Seattle, Washington, United States, 98122
Korea, Republic of
Seoul National University Hospital / Department of Internal Medicine Active, not recruiting
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 120-752
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center Active, not recruiting
Seoul, Korea, Republic of, 120-752
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: April 8, 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 May 05, 2015