Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
Phase 1/2, Open Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Erlotinib With Or Without Pf 02341066 In Patients With Advanced Non Small Cell Adenocarcinoma Of The Lung.
2 other identifiers
interventional
27
1 country
16
Brief Summary
This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer
Started Jan 2010
Typical duration for phase_1 nonsmall-cell-lung-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedResults Posted
Study results publicly available
January 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedOctober 28, 2015
October 1, 2015
1.9 years
August 24, 2009
December 7, 2012
October 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)
Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs).
Baseline up to Day 28
Progression-Free Survival (Phase 2)
Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from AE data (where the outcome was "Death"; date of death reported in notice of death was used).
Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity
Secondary Outcomes (27)
PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)
Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1)
C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1)
C1D15 i.e., 15 days of giving crizotinib and erlotinib
PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)
C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1)
C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib
- +22 more secondary outcomes
Other Outcomes (2)
Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)
Baseline up to 28 days (Cycle 1)
Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)
Baseline up to 28 days (Cycle 1)
Study Arms (2)
Erlotinib
ACTIVE COMPARATORErlotinib + PF-02341066
EXPERIMENTALInterventions
Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only)
For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2
Eligibility Criteria
You may qualify if:
- histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)
- evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease
- tumors must have measurable disease as per RECIST
You may not qualify if:
- known interstitial lung disease
- prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California, Irvine Medical Center Pharmacy
Orange, California, 92868-3298, United States
University of California, Irving - Medical Center
Orange, California, 92868-3298, United States
University of California Irvin
Orange, California, 92868, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Siteman Cancer Center
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center -West County
Creve Coeur, Missouri, 63141, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110-1094, United States
Washington University, School of Medicine
St Louis, Missouri, 63110, United States
OSU East
Columbus, Ohio, 43205, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210, United States
James Care in Kenny
Columbus, Ohio, 43221, United States
Cancer Therapy & Research Center @ UTHSCSA
San Antonio, Texas, 78229, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The sponsor terminated phase 2 of this study; no data was collected during phase 2, leading to phase 2 outcomes not analyzed. The decision was based on strategic considerations regarding the clinical program only; there were no safety concerns.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2009
First Posted
August 26, 2009
Study Start
January 1, 2010
Primary Completion
December 1, 2011
Study Completion
January 1, 2014
Last Updated
October 28, 2015
Results First Posted
January 14, 2013
Record last verified: 2015-10