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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non Small Cell Lung Cancer (NSCLC)

In brief

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).

Key facts

Study ID

NCT01465802

Run by

Pfizer

People needed

236

Starts

2011-12-26

Expected to finish

2015-05-18

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• 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
• Regulatory Management Only TRIO-US Central Administration — Los Angeles, California, United States
• Regulatory Management Only: TRIO-US Central Administration — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Hematology Oncology — Los Angeles, California, United States
• Westwood Bowyer Clinic — Los Angeles, California, United States
• UCLA/Pasadena HealthCare — Pasadena, California, United States
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• SANSUM Clinic — Santa Barbara, California, United States
• Cancer Center of Santa Barbara with SANSUM Clinic — Santa Barbara, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• UCLA Hematology Oncology — Santa Monica, California, United States
• UCLA Santa Monica Medical Center & Orthopaedic Hospital — Santa Monica, California, United States
• Cancer Center of Santa Barbara with SANSUM Clinic — Solvang, California, United States
• City of Hope South Pasadena Cancer Center — South Pasadena, California, United States
• City of Hope — Duarte, California, United States

Full record on ClinicalTrials.gov

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