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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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: 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

NCT01465802•Pfizer

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (81)

City of Hope

Duarte, California, United States

St. Jude Heritage Healthcare

Fullerton, California, United States

UCLA Hematology Oncology

Irvine, California, United States

UC San Diego Medical Center - La Jolla

La Jolla, California, United States

UC San Diego Moores Cancer Center - Investigational Drug Services

La Jolla, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Drug Management Only: UCLA West Medical Pharmacy

Los Angeles, California, United States

Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D.

Los Angeles, California, United States

Drug Management Only: UCLA West Medical Pharmacy

Los Angeles, California, United States

Drug Managment Only: UCLA West Medical Pharmacy

Los Angeles, California, United States

Key Dates

Start Date

December 26, 2011

Primary Completion Date

May 18, 2015

Completion Date

May 18, 2015

Last Updated

January 9, 2019

Enrollment

236

ACTUAL participants

Conditions

Non Small Cell Lung Cancer (NSCLC)

Interventions

Dacomitinib

DRUG

Dacomitinib

DRUG

Doxycycline

DRUG

Probiotic

DRUG

Alclometasone cream

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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