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 September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01465802
First received: October 20, 2011
Last updated: September 8, 2014
Last verified: September 2014
  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: October 2014
Estimated Primary Completion Date: October 2014 (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
Pfizer Investigational Site Completed
Duarte, California, United States, 91010
Pfizer Investigational Site Completed
Fullerton, California, United States, 92835
Pfizer Investigational Site Active, not recruiting
Irvine, California, United States, 92604
Pfizer Investigational Site Completed
La Jolla, California, United States, 92093-0698
Pfizer Investigational Site Completed
Los Angeles, California, United States, 90095-1772
Pfizer Investigational Site Active, not recruiting
Los Angeles, California, United States, 90095
Pfizer Investigational Site Completed
Los Angeles, California, United States, 90095
Pfizer Investigational Site Active, not recruiting
Pasadenax, California, United States, 91105
Pfizer Investigational Site Active, not recruiting
Prismo Beach, California, United States, 93449
Pfizer Investigational Site Active, not recruiting
San Luis Obispo, California, United States, 93401
Pfizer Investigational Site Completed
Santa Barbara, California, United States, 93105
Pfizer Investigational Site Completed
Santa Barbara, California, United States, 93150
Pfizer Investigational Site Active, not recruiting
Santa Maria, California, United States, 93454
Pfizer Investigational Site Active, not recruiting
Santa Monica, California, United States, 90404
Pfizer Investigational Site Completed
Solvang, California, United States, 93463
Pfizer Investigational Site Completed
South Pasadena, California, United States, 91030
Pfizer Investigational Site Active, not recruiting
Valencia, California, United States, 91355
Pfizer Investigational Site Active, not recruiting
Westlake Village, California, United States, 91361
United States, Colorado
Pfizer Investigational Site Completed
Denver, Colorado, United States, 80205-5437
Pfizer Investigational Site Completed
Denver, Colorado, United States, 80205
Pfizer Investigational Site Completed
Denver, Colorado, United States, 80218
Pfizer Investigational Site Active, not recruiting
Grand Junction, Colorado, United States, 81501
Pfizer Investigational Site Completed
Lafayette, Colorado, United States, 80026-3370
Pfizer Investigational Site Completed
Lafayette, Colorado, United States, 80026
United States, Florida
Pfizer Investigational Site Completed
Fort Lauderdale, Florida, United States, 33308
Pfizer Investigational Site Completed
Hollywood, Florida, United States, 33021
Pfizer Investigational Site Completed
Lake City, Florida, United States, 32024
Pfizer Investigational Site Completed
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Pfizer Investigational Site Active, not recruiting
Athens, Georgia, United States, 30607
Pfizer Investigational Site Completed
Savannah, Georgia, United States, 31404
Pfizer Investigational Site Completed
Savannah, Georgia, United States, 31405
United States, Illinois
Pfizer Investigational Site Completed
Chicago, Illinois, United States, 60612
Pfizer Investigational Site Completed
Chicago, Illinois, United States, 60637
Pfizer Investigational Site Completed
Ottawa, Illinois, United States, 61350
Pfizer Investigational Site Completed
Peoria, Illinois, United States, 61615
Pfizer Investigational Site Completed
Peoria, Illinois, United States, 61615-7828
United States, Kansas
Pfizer Investigational Site Completed
Wichita, Kansas, United States, 67208
Pfizer Investigational Site Completed
Wichita, Kansas, United States, 67214
United States, Michigan
Pfizer Investigational Site Completed
Brownstown, Michigan, United States, 48183
Pfizer Investigational Site Completed
Dearborn, Michigan, United States, 48126
Pfizer Investigational Site Completed
Detroit, Michigan, United States, 48202
Pfizer Investigational Site Completed
Novi, Michigan, United States, 48377
Pfizer Investigational Site Completed
West Bloomfield, Michigan, United States, 48322
United States, Mississippi
Pfizer Investigational Site Completed
Corinth, Mississippi, United States, 38834
Pfizer Investigational Site Completed
Southaven, Mississippi, United States, 38671
United States, Missouri
Pfizer Investigational Site Completed
Branson, Missouri, United States, 65616
Pfizer Investigational Site Completed
Springfield, Missouri, United States, 65804
United States, Nevada
Pfizer Investigational Site Completed
Henderson, Nevada, United States, 89052
Pfizer Investigational Site Completed
Henderson & Las Vegas, Nevada, United States, 89052 & 89128
Pfizer Investigational Site Completed
Las Vegas, Nevada, United States, 89148
Pfizer Investigational Site Completed
Las Vegas, Nevada, United States, 89169-3321
Pfizer Investigational Site Completed
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Pfizer Investigational Site Completed
Livingston, New Jersey, United States, 07039
United States, New York
Pfizer Investigational Site Active, not recruiting
Bronx, New York, United States, 10461
Pfizer Investigational Site Active, not recruiting
Bronx, New York, United States, 10467
Pfizer Investigational Site Completed
New York, New York, United States, 10011
Pfizer Investigational Site Completed
New York City, New York, United States, 10032
Pfizer Investigational Site Completed
New York,, New York, United States, 10003
Pfizer Investigational Site Completed
Stony Brook, New York, United States, 11794-9447
United States, North Carolina
Pfizer Investigational Site Completed
Hickory, North Carolina, United States, 28603
Pfizer Investigational Site Completed
Lenoir, North Carolina, United States, 28645
Pfizer Investigational Site Completed
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Pfizer Investigational Site Completed
Bismarck, North Dakota, United States, 58501
United States, South Carolina
Pfizer Investigational Site Active, not recruiting
Charleston, South Carolina, United States, 29414
Pfizer Investigational Site Active, not recruiting
Charleston, South Carolina, United States, 29403-5744
United States, Tennessee
Pfizer Investigational Site Completed
Memphis, Tennessee, United States, 38104
Pfizer Investigational Site Completed
Memphis, Tennessee, United States, 38120
United States, Texas
Pfizer Investigational Site Active, not recruiting
Fort Worth, Texas, United States, 76177
Pfizer Investigational Site Completed
Fort Worth, Texas, United States, 76177
United States, Vermont
Pfizer Investigational Site Completed
Burlington, Vermont, United States, 05401
Pfizer Investigational Site Completed
Burlington, Vermont, United States, 05405
United States, Virginia
Pfizer Investigational Site Active, not recruiting
Arlington, Virginia, United States, 22205
Pfizer Investigational Site Active, not recruiting
Fairfax, Virginia, United States, 22031
Pfizer Investigational Site Active, not recruiting
Gainesville, Virginia, United States, 20155
Pfizer Investigational Site Active, not recruiting
Leesburg, Virginia, United States, 20176
Pfizer Investigational Site Active, not recruiting
Winchester, Virginia, United States, 22601
Pfizer Investigational Site Active, not recruiting
Woodbridge, Virginia, United States, 22191
United States, Washington
Pfizer Investigational Site Completed
Issaquah, Washington, United States, 98029
Pfizer Investigational Site Completed
Seattle, Washington, United States, 98122
Pfizer Investigational Site Completed
Seattle, Washington, United States, 98104
Korea, Republic of
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site 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: September 8, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014