Clinical trial NCT01858389: A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer
Official title: Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced Nsclc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
T790M mutation. dacomitinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.


Eligibility criteria: Inclusion Criteria:

* Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
* Evidence of T790M mutation to enroll in Cohort A.
* Evidence of measurable disease by radiographic technique.
* Adequate organ function.

Exclusion Criteria:

* Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.
* Symptomatic brain metastases.
* Uncontrolled or significant cardiovascular disease.
* Pregnant or breastfeeding.

Primary outcomes:
measure: Best Overall Response (BOR) in Participants With T790M Mutation
timeFrame: From baseline until disease progression, up to 61 weeks.
measure: Objective Response Rate (ORR) in Participants With T790M Mutation
timeFrame: From baseline to disease progression, up to 61 weeks.
Secondary outcomes:
measure: Disease Control Rate (DCR) for Participants With T790M Mutation
timeFrame: From baseline to baseline to disease progression, up to 61 weeks.
measure: Duration of Response in Participants With T790M Mutation
timeFrame: From baseline to date of disease progression or death, up to 61 weeks.
measure: Progression-free Survival
timeFrame: From baseline to disease progression or death, up to 61 weeks.
measure: Progression-free Survival at 4 Months
timeFrame: Month 4
measure: Maximum Plasma Concentration (Cmax) for Dacomitinib and PF-05199265
timeFrame: Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0.
measure: Time to Maximum Plasma Concentration (Tmax) for Dacomitinib and PF-05199265
timeFrame: Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0.
measure: Changes From Time-matched Baseline in Adjusted Fridericia Corrected QT Interval (QTcF) on Echocardiogram (ECG)
timeFrame: From Baseline to Cycle 0, Day 4
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Washington, D.C.
country: United States
facility: Georgetown University Hospital-Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Washington, D.C.
country: United States
facility: Georgetown University Medical Center Department of Pharmacy, Research
state: District of Columbia
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center-Rockefeller Outpatient Pavilion
state: New York
city: Pittsburgh
country: United States
facility: Investigational Drug Service, Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center-Simmons Cancer Center Pharmacy
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern University Hospital - William P. Clements, Jr.
state: Texas
city: Dallas
country: United States
facility: UT Southwestern University Hospital - Zale Lipshy
state: Texas
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tan W, Giri N, Quinn S, Wilner K, Parivar K. Evaluation of the potential effect of dacomitinib, an EGFR tyrosine kinase inhibitor, on ECG parameters in patients with advanced non-small cell lung cancer. Invest New Drugs. 2020 Jun;38(3):874-884. doi: 10.1007/s10637-019-00887-0. Epub 2019 Dec 19.
citation: Yu HA, Ahn MJ, Cho BC, Gerber DE, Natale RB, Socinski MA, Giri N, Quinn S, Sbar E, Zhang H, Giaccone G. Phase 2 study of intermittent pulse dacomitinib in patients with advanced non-small cell lung cancers. Lung Cancer. 2017 Oct;112:195-199. doi: 10.1016/j.lungcan.2017.08.017. Epub 2017 Aug 23.