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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

Last updated on November 12, 2019

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

NCT01465802
Pfizer
Completed
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

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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 SummaryTo 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 DescriptionNot 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 DateMay 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 CountriesPuerto Rico
 
Administrative Information
NCT Number  ICMJE NCT01465802
Other Study ID Numbers  ICMJE A7471042
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

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