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

Condition(s) targeted: Non Small Cell Lung Cancer (NSCLC)

Intervention: Dacomitinib Plus Blinded Doxycycline or Placebo (Drug); Dacomitinib Plus Probiotic Plus Topical Alclometasone cream (Drug); Dacomitinib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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).

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

Primary outcome:

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.

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

the first 8 weeks of treatment by arm.

Cohort I:Skindex-16 Scale scores (Total score, Symptoms score, Emotions score, Functioning score)

Cohort II: Mucositis Daily Questionaire (diarrhea questions) Skindex-16 Scale scores (Total score, Symptoms score, Emotions score, Functioning score)

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

Secondary outcome:

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.

Concomitant medication (both prescribed and non-prescription) used for dermatologic AEs of interest, diarrhea, and mucositis.

Trough concentrations (Ctrough) of PF-00299804 and PF-05199265, as determined from trough plasma samples.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Seoul National University Hospital / Department of Internal Medicine, Seoul 110-744, Korea, Republic of

Severance Hospital, Seoul 120-752, Korea, Republic of

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center, Seoul 120-752, Korea, Republic of

Yonsei University College of Medicine, Severance Hospital, Seoul 120-752, Korea, Republic of

University Of Colorado, Aurora, California 80045, United States

City of Hope, Duarte, California 91010, United States

St. Jude Heritage Healthcare - Virginia K. Crosson Cancer Center, Fullerton, California 92835, United States

UCLA Hematology Oncology, Irvine, California 92604, United States

Moores UC San Diego Cancer Center Clinical Trials, La Jolla, California 92093-0698, 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

Drug Management Only: UCLA West Medical Pharmacy, Los Angeles, California 90095-1772, United States

Drug Management Only: UCLA West Medical Pharmacy, Los Angeles, California 90095, United States

Drug Management Only: UCLA West Modical 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

Regulatoty Management Only: TRIO-US Central Administration, Los Angeles, California 90095, United States

Ronald Reagan UCLA Medical Center, Los Angeles, California 90095, United States

Ronald Reagan UCLA Medical Center - Drug Information 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, Pasadenax, California 91105, United States

Radiology Associates of San Luis Obispo, Prismo Beach, California 93449, 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

Cancer Center of Santa Barbara with SANSUM Clinic, Santa Barbara, California 93105, United States

SANSUM Clinic, Santa Barbara, California 93105, 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

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 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

Quest, Miramar, Florida 33025, United States

Memorial Cancer Institute, Pembroke Pines, Florida 33028, United States

Memorial Hospital West, Pembroke Pines, Florida 33028, United States

Memorial West Cancer Institute, Pembroke Pines, Florida 33028, United States

Northeast Georgia Cancer Care, LLC, Athens, Georgia 30607, United States

Summit Cancer Care, P.C.,, Savannah, Georgia 31404, United States

Summit Cancer Care, P.C.,, Savannah, Georgia 31405, United States

Solstas Lab Partners, Valdosta, Georgia 31602, United States

Emmanuel Semmes, RPh (or Ami Patel, Pharm D) University of Chicago, Chicago, Illinois 60637, United States

Rush University Medical Center, Division of Hematology & Oncology, Chicago, Illinois 60612, United States

The University of Chicago, Chicago, Illinois 60637, United States

The University of Chicago Medical Center (UCMC), Chicago, Illinois 60637-1426, United States

The University of Chicago Medical Center- Drug Shipment Only, Chicago, Illinois 60637, United States

University of Chicago Medical Center, Chicago, Illinois 60637-1447, United States

Illinois CancerCare, P.C., Peoria, Illinois 61615, United States

Oncology Hematology Associates Of Central Illinois, P.C. D.B.A Illinois CancerCare, P.C., Peoria, Illinois 61615, United States

Cancer Center of Kansas, Wichita, Kansas 67214, United States

Cancer Center of Kansas - Emporia, Wichita, Kansas 67214, United States

Cancer Center of Kansas - Murdock, Wichita, Kansas 67208, United States

Josephine Ford Cancer Center-Downriver, Brownstown, Michigan 48183, United States

Henry Ford Medical Center - Fairlane, Dearborn, Michigan 48126, United States

Henry Ford Health Hospital, Detroit, Michigan 48202, United States

Henry Ford Medical Center - Columbus Center, Novi, Michigan 48377, United States

Henry Ford Medical Center - West Bloomfield, W. Bloomfield, Michigan 48322, United States

The West Clinic, PC - Corinth, Corinth, Mississippi 38834, United States

The West Clinic, PC - Southaven, Southaven, Mississippi 38671, United States

Mercy Clinic Cancer & Hematology-Branson, Branson, Missouri 65616, United States

Mercy Clinic Cancer & Hematology- Chub O-Reilly Cancer Center, Springfield, Missouri 65807, United States

Mercy Hospital Springfield, Springfield, Missouri 65804, United States

Mercy Medical Research Institute, Springfield, Missouri 65807, United States

St. John's Medical Research Institute, Inc., Springfield, Missouri 65807, United States

Comprehensive Cancer Centers of Nevada, Henderson, Nevada 89014, United States

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada 89169, United States

Comprehensive Cancer Centers of Nevada - Peak Dr., Las Vegas, Nevada 89128, United States

Saint Barnabas Medical Center, Livingston, New Jersey 07039, United States

Montefiore Medical Center, Bronx, New York 10467, United States

Montefiore-Einstein Center for Cancer Care, Bronx, New York 10461, United States

New York Presbytarian Hospital,Columbia University Medical Center, New York City, New York 10032, 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

New York Presbytarian Hospital,Columbia University Medical Center, New York, New York 10032, United States

Stony Brook University Medical Center Cancer Center, Stony Brook, New York 11794-9447, United States

Carolina Oncology Specialists, PA, Hickory, North Carolina 28602, United States

Wake Forest University Health Services, Winston-Salem, North Carolina 27157, United States

Legacy Pharma Research, Bismarck, North Dakota 58501, United States

Mid Dakota Clinic, 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 38120, United States

The West Clinic, PC - Memphis, Memphis, Tennessee 38104, United States

Investigational Product Center (IPC), Fort Worth, Texas 76177, United States

Investigational Products Center (IPC) (drug shipment only), 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

Arlington-Fairfax Hematology Oncology P.C., Arlington, Virginia 22205, United States

Virginia Cancer Specialists, PC, Arlington, Virginia 22205, United States

Arlington Fairfax Hematology Oncology, Fairfax, Virginia 22031, United States

Virginia Cancer Specialists, PC, Fairfax, Virginia 22031, United States

Virginia Cancer Specialists, PC, Gainesville, Virginia 20155, United States

Virginia Cancer Specialists, PC, Leesburg, Virginia 20176, United States

Virginia Cancer Specialists, Virginia, Virginia 22205, United States

Virginia Cancer Specialists, PC, Winchester, Virginia 22601, United States

Virginia Cancer Specialists, PC, Woodbridge, Virginia 22191, United States

Swedish Cancer Institute Issaquah Campus, Issaquah, Washington 98029, United States

Swedish Cancer Institute, Seattle, Washington 98104, United States

Swedish Medical Center First Hill IDS Pharmacy, Seattle, Washington 98122, United States

To obtain contact information for a study center near you, click here.

Starting date: December 2011
Last updated: June 22, 2015