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Study Of Dacomitinib (PF-0029...

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: 2019-01-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-26

Study Completion Date

2015-05-18

Brief Summary

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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).

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Detailed Description

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Conditions

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Non Small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Dacomitinib

Intervention Type DRUG

Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent

Doxycycline

Intervention Type DRUG

Doxycycline or Doxycycline placebo BID for 4 weeks

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)

Group Type EXPERIMENTAL

Dacomitinib

Intervention Type DRUG

Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent

Probiotic

Intervention Type DRUG

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)

Alclometasone cream

Intervention Type DRUG

Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks

Cohort III

Cohort III is an interrupted dosing schedule of dacomitinib in the first cycle only

Group Type EXPERIMENTAL

Dacomitinib

Intervention Type DRUG

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

Interventions

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Dacomitinib

Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent

Intervention Type DRUG

Dacomitinib

Intervention Type DRUG

Doxycycline

Doxycycline or Doxycycline placebo BID for 4 weeks

Intervention Type 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)

Intervention Type DRUG

Alclometasone cream

Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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City of Hope

Duarte, California, United States

Site Status

St. Jude Heritage Healthcare

Fullerton, California, United States

Site Status

UCLA Hematology Oncology

Irvine, California, United States

Site Status

UC San Diego Medical Center - La Jolla

La Jolla, California, United States

Site Status

UC San Diego Moores Cancer Center - Investigational Drug Services

La Jolla, California, United States

Site Status