- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00548093
PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
May 20, 2019 updated by: Pfizer
A PHASE 2, OPEN-LABEL, TWO ARM TRIAL TO EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS WITH ADVANCED NSCLC AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN AND FAILURE OF PRIOR TREATMENT WITH ERLOTINIB
To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
-
Duarte, California, United States, 91010
- City of Hope
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Pasadena, California, United States, 91105
- City of Hope Medical Group
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South Pasadena, California, United States, 91030
- City of Hope South Pasadena Cancer Center
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital
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Aurora, Colorado, United States, 80045
- Rocky Mountain Lions Eye Institute
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital, Anschutz Cancer Pavilion
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital, Anschutz Inpatient Pavilion
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30322
- Emory Clinic
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute
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Atlanta, Georgia, United States, 30303
- Grady Health Systems
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Atlanta, Georgia, United States, 30308
- Emery University Hospital Midtown
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Maryland
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Bethesda, Maryland, United States, 20892
- CCR, National Cancer Institute
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute/Wayne State University
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Farmington Hills, Michigan, United States, 48334
- Lawrence and Idell Weisberg Cancer Treatment Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Advanced Non-Small Cell Lung Cancer (NSCLC)
- Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
- Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
- Measurable disease .
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Tissue available for KRAS/ EGFR testing
- Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN
Exclusion Criteria:
- Chemotherapy
- Radiotherapy
- Biological or investigational agents within 4 weeks of baseline disease assessment.
- Patients who lack of tolerance of erlotinib therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
descriptive: adenocarcinoma histology
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PF-00299804 orally at 45 mg daily, on continuous schedule
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Experimental: 2
descriptive: non-adenocarcinoma histology
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PF-00299804 orally at 45 mg daily, on continuous schedule
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Overall Response (BOR) in Participants With Adenocarcinoma Histology
Time Frame: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
|
BOR:best response recorded from treatment start until disease progression as per Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response: disappearance of all lesions.
Partial Response (PR):greater than or equal to (>=)30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD.
Progressive disease (PD):>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion.
Stable disease:neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
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Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Overall Response (BOR) in Participants With Non-Adenocarcinoma Histology
Time Frame: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
|
BOR: best response recorded from treatment start until disease progression as per RECIST.
Complete Response: disappearance of all lesions.
PR: >=30% decrease in SLDs of TLs taking as reference baseline SLD.
PD: >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion.
Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
|
Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
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Duration of Response (DR)
Time Frame: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
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Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer.
Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
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Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
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Percent Probability of Progression-free Survival (PFS) at Month 6
Time Frame: Up to 6 months after the start of study medication
|
Probability of being event free (event defined as PD or death due to any cause) at 6 months after the first dose of study treatment.
PFS was defined as the time from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first.
PFS was calculated as (first event date (if not reached, censored at the last known event-free date) minus first dosing date plus 1).
Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.
PD was defined as at least a 20% increase in the sum of the longest diameters of the target lesions taking as a reference the smallest sum of the longest diameters recorded since treated started or the appearance of 1 or more new lesions.
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Up to 6 months after the start of study medication
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Percent Probability of Overall Survival at Months 6 and 12
Time Frame: Months 6, 12
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Probability of being alive at 6 and 12 months after the first dose of study medication.
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Months 6, 12
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Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)]
Time Frame: 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
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The pharmacokinetic (PK) samples collected between 22-26 hours post dose on Day 1 of Cycle 1 were within the pre-specified time window for the 24-hour post dose sample and were used for calculation of AUC (0-24) on Day 1 of Cycle 1.
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0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
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Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
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0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
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0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
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Human Epidermal Growth Factor-2 (HER-2) and Epidermal Growth Factor Receptor (EGFR) Levels in Serum
Time Frame: Baseline [pre-dose on Cycle 1 Day 1 (C1D1)], then pre-dose on Day 1 of each cycle, end of treatment (Day 936)
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Human epidermal growth factor receptor 2 (HER2) is a transmembrane protein that plays a pivotal role in growth factor signal transduction and epidermal growth factor receptor (EGFR) is a cell surface protein that binds to epidermal growth factor.
Levels of the HER-2 and EGFR extracellular domains in serum were assessed by enzyme-linked immunosorbent assay (ELISA).
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Baseline [pre-dose on Cycle 1 Day 1 (C1D1)], then pre-dose on Day 1 of each cycle, end of treatment (Day 936)
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Number of Participants With Human Epidermal Growth Factor Family (HER-Family) and Kirsten Rat Sarcoma (KRAS) Gene Mutation Status From Free Tumor Deoxy- Ribonucleic Acid (DNA) in Blood at Screening
Time Frame: Screening
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HER-family is a family of transmembrane protein that plays a pivotal role in growth factor signal transduction and Kirsten Rat Sarcoma (KRAS) gene is an oncogene that encodes a small guanosine triphosphatase (GTPase) transductor protein called KRAS.
The mutation status of HER and KRAS genes in tumor DNA present in plasma was determined using a polymerase chain reaction (PCR)-based assay.
The gene that is most common in a particular natural population is known as the wild type.
Any form of the gene other than the wild type is known as a mutant form.
Number of participants with HER-Family and KRAS gene mutation were classified as: wild type, mutant and unknown.
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Screening
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European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Time Frame: Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
|
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties).
Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent').
Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
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Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
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European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score
Time Frame: Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
|
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy.
The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain).
Recall period: past week; response range: not at all to very much.
Scale score range: 0 to 100.
Higher symptom score = greater degree of symptoms.
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Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
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Dermatology Life Quality Index (DLQI) Score
Time Frame: Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
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Self-administered questionnaire to measure health-related quality of life (QoL) of adult participants suffering from skin disease; 10 questions concerning participants' perception of impact of their disease over last week encompassing aspects such as symptoms or feelings, daily activities, leisure, work or school, personal relationships and treatment.
Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much).
Scores of individual questions (0-3) were added to yield a total score (0-30); higher score = greater impairment of participant's QoL.
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Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
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Percentage of Participants With Progression-free Survival (PFS)
Time Frame: Month 6
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PFS is defined as time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause.
PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
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Month 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2008
Primary Completion (Actual)
March 16, 2010
Study Completion (Actual)
June 11, 2012
Study Registration Dates
First Submitted
October 19, 2007
First Submitted That Met QC Criteria
October 19, 2007
First Posted (Estimate)
October 23, 2007
Study Record Updates
Last Update Posted (Actual)
May 21, 2019
Last Update Submitted That Met QC Criteria
May 20, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A7471002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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