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

NCT01465802

Last updated date
Study Location
City of Hope
Duarte, California, 91010, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Cancer (NSCLC)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Non Small Cell Lung Cancer (NSCLC)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
NCT01465802
  1. Duarte, California
  2. Fullerton, California
  3. Irvine, California
  4. La Jolla, California
  5. La Jolla, California
  6. La Jolla, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Los Angeles, California
  13. Los Angeles, California
  14. Los Angeles, California
  15. Los Angeles, California
  16. Pasadena, California
  17. San Diego, California
  18. San Luis Obispo, California
  19. Santa Barbara, California
  20. Santa Barbara, California
  21. Santa Maria, California
  22. Santa Monica, California
  23. Santa Monica, California
  24. Solvang, California
  25. South Pasadena, California
  26. Valencia, California
  27. Westlake Village, California
  28. Denver, Colorado
  29. Grand Junction, Colorado
  30. Lafayette, Colorado
  31. Lonetree, Colorado
  32. Fort Lauderdale, Florida
  33. Hollywood, Florida
  34. Lake City, Florida
  35. Pembroke Pines, Florida
  36. Athens, Georgia
  37. Savannah, Georgia
  38. Savannah, Georgia
  39. Chicago, Illinois
  40. Chicago, Illinois
  41. Chicago, Illinois
  42. Peoria, Illinois
  43. Wichita, Kansas
  44. Wichita, Kansas
  45. Brownstown, Michigan
  46. Dearborn, Michigan
  47. Detroit, Michigan
  48. Novi, Michigan
  49. West Bloomfield, Michigan
  50. Corinth, Mississippi
  51. Southaven, Mississippi
  52. Branson, Missouri
  53. Springfield, Missouri
  54. Springfield, Missouri
  55. Las Vegas, Nevada
  56. Las Vegas, Nevada
  57. Livingston, New Jersey
  58. Bronx, New York
  59. Bronx, New York
  60. New York, New York
  61. New York, New York
  62. New York, New York
  63. Stony Brook, New York
  64. Hickory, North Carolina
  65. Winston-Salem, North Carolina
  66. Bismarck, North Dakota
  67. Bismarck, North Dakota
  68. Bismarck, North Dakota
  69. Charleston, South Carolina
  70. Memphis, Tennessee
  71. Memphis, Tennessee
  72. Fort Worth, Texas
  73. Fort Worth, Texas
  74. Burlington, Vermont
  75. Burlington, Vermont
  76. Fairfax, Virginia
  77. Issaquah, Washington
  78. Seattle, Washington
  79. Seattle, Washington
  80. Seoul,
  81. Seoul,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer (NSCLC)
Intervention  ICMJE
  • Drug: Dacomitinib
    Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent
  • 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
  • Drug: Doxycycline
    Doxycycline or Doxycycline placebo BID for 4 weeks
  • Drug: Probiotic
    VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28)
  • Drug: Alclometasone cream
    Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks
Study Arms  ICMJE
  • Experimental: Cohort I
    Arm A: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline placebo orally BID for 4 weeks Arm B: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline 100 mg orally BID for 4 weeks
    Interventions:
    • Drug: Dacomitinib
    • Drug: Doxycycline
  • Experimental: Cohort II
    Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28)
    Interventions:
    • Drug: Dacomitinib
    • Drug: Probiotic
    • Drug: Alclometasone cream
  • Experimental: Cohort III
    Cohort III is an interrupted dosing schedule of dacomitinib in the first cycle only
    Intervention: Drug: Dacomitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2015)
236
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2011)
240
Actual Study Completion Date  ICMJE May 18, 2015
Actual Primary Completion Date May 18, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT01465802
Other Study ID Numbers  ICMJE A7471042
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP