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
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 9, 2019 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Pfizer
- Interventions being studied
- Drug: Dacomitinib; Drug: Dacomitinib; Drug: Doxycycline; Drug: Probiotic; Drug: Alclometasone cream
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- St. Jude Heritage HealthcareFullerton, California
- UCLA Hematology OncologyIrvine, California
- UC San Diego Medical Center - La JollaLa Jolla, California
- UC San Diego Moores Cancer Center - Investigational Drug ServicesLa Jolla, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- Drug Management Only: UCLA West Medical PharmacyLos Angeles, California
- Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D.Los Angeles, California
- Drug Management Only: UCLA West Medical PharmacyLos Angeles, California
- Drug Managment Only: UCLA West Medical PharmacyLos Angeles, California
- Regulatory Management Only TRIO-US Central AdministrationLos Angeles, California
- Regulatory Management Only: TRIO-US Central AdministrationLos Angeles, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 9, 2019. Always confirm current availability with the study team.