A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01858389
First received: May 6, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Dacomitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced NSCLC

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Best Overall Response [ Time Frame: Baseline up to 78 weeks ] [ Designated as safety issue: No ]
    Number of participants with best overall response recorded from the start of treatment until disease progression according to RECIST 1.1. Complete Response are defined as disappearance of all non-nodal lesions (target and/or non-target) without new lesions. All lymph nodes must have reduction in short axis to "normal" size (<10mm). Partial Response are those with at least 30% decrease in sum of the diameters of target lesions (short diameter for target nodes and longest diameter for other target lesions) taking as a reference the baseline sum diameters, with absence of new lesions and persistence of any non target lesions and/or tumor marker level above the normal limits. Best Overall Response of Stable Disease may be assigned when response cannot be confirmed given minimum criteria for Stable Disease duration is met.

  • Objective Response Rate [ Time Frame: Baseline up to 78 weeks ] [ Designated as safety issue: No ]
    Percentage of participants with Overall Response based assessment of confirmed complete response or confirmed partial response according to RECIST 1.1. Confirmed response are those that persist on repeat imaging assessment at least 4 weeks after initial documentation of response and before progression. Complete Response are defined as disappearance of all non-nodal lesions (target and/or non-target) without new lesions. All lymph nodes must have reduction in short axis to "normal" size (<10mm). Partial Response are those with at least 30% decrease in sum of the diameters of target lesions (short diameter for target nodes and longest diameter for other target lesions) taking as a reference the baseline sum diameters, with absence of new lesions and persistence of any non target lesions and/or tumor marker level above the normal limits.


Secondary Outcome Measures:
  • Disease Control Rate [ Time Frame: Start of study drug until RECIST defined progressive disease, or discontinuation from treatment, or start of another anti-cancer treatment assessed up to 78 weeks ] [ Designated as safety issue: No ]
    For patients in Cohort A, Disease Control is the best response of Complete Response, Partial Response or Stable Disease from the start of treatment until disease progression according to the RECIST v1.1 guidelines. Disease Control Rate is calculated as the proportion of patients with an objective response or Stable Diseaes relative to the total number of patients enrolled.

  • Duration of Response [ Time Frame: From start of treatment to disease progression or death due to any cause or discontinuation from the treatment or start of a new anti-cancer treatment assessed up to 78 weeks ] [ Designated as safety issue: No ]
    For patients in Cohort A, Duration of Response is defined as the time from first documentation of response (Complete Response or Partial Response whichever occurs first) to the date of disease progression or to death due to any cause, whichever occurs first.

  • Progression Free Survival [ Time Frame: From start of treatment to disease progression or death due to any cause or discontinuation from the treatment or start of a new anti-cancer treatment assessed up to 78 weeks ] [ Designated as safety issue: No ]
    Progression Free Survival is defined as the time from the date of first dosing of dacomitinib to the date of disease progression or death due to any cause, whichever occurs first.

  • Progression Free Survival at 4 months [ Time Frame: From start of treatment to disease progression or death due to any cause or discontinuation from the treatment or start of a new anti-cancer treatment assessed up to 78 weeks ] [ Designated as safety issue: No ]
    Progression Free Survival at 4 months is defined as the proportion of patients who are alive without disease progression at 4 months relative to all patients enrolled.

  • delta QT corrected [ Time Frame: Cycle 0 days 1 through 4: pre-dose (0 hour) up to 10 hours post dose ] [ Designated as safety issue: Yes ]
    Time-matched adjusted QTcorrected change from baseline on Day 4 of Cycle 0 (Cohorts A and B)

  • delta QT corrected and dacomitinib plasma concentration [ Time Frame: Cycle 0 days 1 through 4: pre-dose (0 hour) up to 10 hours post dose ] [ Designated as safety issue: Yes ]
    Slope of the linear regression between delta QT corrected and dacomitinib plasma concentration


Estimated Enrollment: 35
Study Start Date: July 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor.
Drug: Dacomitinib
Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg.
Experimental: Cohort B
Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations.
Drug: Dacomitinib
Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858389

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, California
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90048
United States, District of Columbia
Pfizer Investigational Site Recruiting
Washington, District of Columbia, United States, 20007
United States, New York
Pfizer Investigational Site Recruiting
New York, New York, United States, 10065
Pfizer Investigational Site Recruiting
New York, New York, United States, 10017
Pfizer Investigational Site Recruiting
New York, New York, United States, 10022
Pfizer Investigational Site Recruiting
New York,, New York, United States, 10065
United States, Pennsylvania
Pfizer Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75235
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75390
Korea, Republic of
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01858389     History of Changes
Other Study ID Numbers: A7471047
Study First Received: May 6, 2013
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Non-small cell lung cancer
T790M mutation. dacomitinib

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014