An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00932893
First received: June 30, 2009
Last updated: June 4, 2013
Last verified: June 2013
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Purpose
This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: PF-02341066 Drug: Pemetrexed Drug: Docetaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of PF-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Non-Small Cell Lung Cancer Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Progression-Free Survival (PFS) [ Time Frame: Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) ] [ Designated as safety issue: No ]PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Secondary Outcome Measures:
- Overall Survival (OS) [ Time Frame: Randomization until death (up to 112 weeks) ] [ Designated as safety issue: No ]OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.
- Overall Survival Probability at Month 6 and Month 12 [ Time Frame: Month 6, 12 ] [ Designated as safety issue: No ]Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.
- Percentage of Participants With Objective Response (OR) [ Time Frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) ] [ Designated as safety issue: No ]Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.
- Percentage of Participants With Disease Control at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.
- Percentage of Participants With Disease Control at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
- Duration of Response (DR) [ Time Frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) ] [ Designated as safety issue: No ]Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
- Time to Tumor Response (TTR) [ Time Frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) ] [ Designated as safety issue: No ]Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
- Pre-Dose Plasma Concentration (Ctrough) of Crizotinib [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2, 3, 5 ] [ Designated as safety issue: No ]Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
- Pre-Dose Plasma Concentration at Steady State (Ctrough, ss) of Crizotinib [ Time Frame: Pre-dose on Day 15 of Cycle 1 ] [ Designated as safety issue: No ]Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
- Number of Participants With Categorical Maximum QTcF for Crizotinib [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2 ] [ Designated as safety issue: Yes ]QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to <480 msec, 480 msec to <500 msec, and more than or equal to (>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
- Percentage of Participants With Echinoderm Microtubule Associated Protein-Like 4-Anaplastic Lymphoma Kinase (EML4-ALK) Fusion Variants [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]
- Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]
- Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough [ Time Frame: Baseline up to end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer [EORTC QLQ-LC13]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks) ] [ Designated as safety issue: No ]EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, 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 for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13) [ Time Frame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]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 dyspnea 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: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.
- European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
| Enrollment: | 347 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-02341066 |
Drug: PF-02341066
PF-02341066, 250 mg BID will be administered orally on a continuous schedule
|
|
Active Comparator: Pemetrexed or Docetaxel
Investigator selection of either pemetrexed or docetaxel as the active comparator
|
Drug: Pemetrexed
Pemetrexed, 500 mg/m^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
Drug: Docetaxel
Docetaxel, 75 mg/m^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- histologically or cytologically proven diagnosis of non-small cell lung cancer
- positive for the ALK fusion gene (test provided by a central laboratory)
- must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
- tumors must be measurable
Exclusion Criteria:
- prior treatment with PF-02341066
- current treatment in another clinical trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932893
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| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Pfizer Investigational Site | |
| Bakersfield, California, United States, 93309 | |
| Pfizer Investigational Site | |
| Beverly Hills, California, United States, 90211 | |
| Pfizer Investigational Site | |
| Beverly Hills, California, United States, 90211-1850 | |
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| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92093-0698 | |
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| Los Angeles, California, United States, 90095 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90095-6984 | |
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| Los Angeles, California, United States, 90404 | |
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| Orange, California, United States, 92868-3298 | |
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| Palo Alto, California, United States, 94305 | |
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| Sacramento, California, United States, 95817 | |
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| San Diego, California, United States, 92103 | |
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| Santa Monica, California, United States, 90404 | |
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| Santa Rosa, California, United States, 95403 | |
| United States, Colorado | |
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| Aurora, Colorado, United States, 80045 | |
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| Denver, Colorado, United States, 80205 | |
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| Lafayette, Colorado, United States, 80026 | |
| United States, Connecticut | |
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| New Haven, Connecticut, United States, 06510 | |
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| New Haven, Connecticut, United States, 06520 | |
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| New Haven, Connecticut, United States, 06519 | |
| United States, Florida | |
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| Hollywood, Florida, United States, 33021 | |
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| Lake Worth, Florida, United States, 33461 | |
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| Pembroke Pines, Florida, United States, 33028 | |
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| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
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| Atlanta, Georgia, United States, 30308 | |
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| Atlanta, Georgia, United States, 30341 | |
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| Atlanta, Georgia, United States, 30322 | |
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| Decatur, Georgia, United States, 30033 | |
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| Macon, Georgia, United States, 31217 | |
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| Marietta, Georgia, United States, 30060 | |
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| Sandy Springs, Georgia, United States, 30342 | |
| United States, Hawaii | |
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| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
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| Chicago, Illinois, United States, 60612 | |
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| Chicago, Illinois, United States, 60637 | |
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| Harvey, Illinois, United States, 60426 | |
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| Tinley Park, Illinois, United States, 60477 | |
| United States, Indiana | |
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| Hobart, Indiana, United States, 46342 | |
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| Indianapolis, Indiana, United States, 46202 | |
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| Indianapolis, Indiana, United States, 46290 | |
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| Munster, Indiana, United States, 46321 | |
| United States, Maryland | |
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| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
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| Boston, Massachusetts, United States, 02215 | |
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| Boston, Massachusetts, United States, 02114 | |
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| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
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| Detroit, Michigan, United States, 48201 | |
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| Farmington Hills, Michigan, United States, 48334 | |
| United States, Missouri | |
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| Creve Coeur, Missouri, United States, 63141 | |
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| St. Louis, Missouri, United States, 63110-1094 | |
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| St. Louis, Missouri, United States, 63110 | |
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| St. Peters, Missouri, United States, 63376 | |
| United States, New Hampshire | |
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| Lebanon, New Hampshire, United States, 03756-0001 | |
| United States, New York | |
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| Lake Success, New York, United States, 11042 | |
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| Manhasset, New York, United States, 11030 | |
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| New Hyde Park, New York, United States, 11040 | |
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| New York, New York, United States, 10032 | |
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| New York, New York, United States, 10022` | |
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| New York, New York, United States, 10021 | |
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| Oneida, New York, United States, 13421 | |
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| Oswego, New York, United States, 13126 | |
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| Syracuse, New York, United States, 13210-2306 | |
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| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
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| Chapel Hill, North Carolina, United States, 27599-7600 | |
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| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Ohio | |
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| Cleveland, Ohio, United States, 44195 | |
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| Columbus, Ohio, United States, 43221 | |
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| Columbus, Ohio, United States, 43205 | |
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| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
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| Beaverton, Oregon, United States, 97006 | |
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| Gresham, Oregon, United States, 97030 | |
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| Portland, Oregon, United States, 97239 | |
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| Portland, Oregon, United States, 97210 | |
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| Tualatin, Oregon, United States, 97062 | |
| United States, Pennsylvania | |
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| Hershey, Pennsylvania, United States, 17033-0850 | |
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| Philadelphia, Pennsylvania, United States, 19104 | |
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| Philadelphia, Pennsylvania, United States, 19111 | |
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| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Rhode Island | |
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| East Providence, Rhode Island, United States, 02915 | |
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| East Providence, Rhode Island, United States, 02914 | |
| United States, Tennessee | |
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| Dickson, Tennessee, United States, 37055 | |
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| Franklin, Tennessee, United States, 37067 | |
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| Gallatin, Tennessee, United States, 37066 | |
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| Hermitage, Tennessee, United States, 37076 | |
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| Lebanon, Tennessee, United States, 37087 | |
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| Murfreesboro, Tennessee, United States, 37130 | |
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| Nashville, Tennessee, United States, 37203 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37232-5536 | |
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| Nashville, Tennessee, United States, 37232-7610 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37207 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37211 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37205 | |
| Pfizer Investigational Site | |
| Smyrna, Tennessee, United States, 37167 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98104 | |
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| Seattle, Washington, United States, 98109 | |
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| Seattle, Washington, United States, 98195 | |
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| Seattle, Washington, United States, 98122 | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Camperdown, New South Wales, Australia, 2050 | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| East Melbourne, Victoria, Australia, 3002 | |
| Australia, Western Australia | |
| Pfizer Investigational Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Brazil | |
| Pfizer Investigational Site | |
| Salvador, BA, Brazil, 40170-110 | |
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| Rio de Janeiro, RJ, Brazil, 20231 -050 | |
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| Ijui, RS, Brazil, 98700-000 | |
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| Porto Alegre, RS, Brazil, 90050-170 | |
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| Porto Alegre, RS, Brazil, 90610-000 | |
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| Jau, Sao Paulo, Brazil, 17210-120 | |
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| Barretos, SP, Brazil, 14784-400 | |
| Pfizer Investigational Site | |
| Sao Paulo, SP, Brazil, 01246-000 | |
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| Sao Paulo, SP, Brazil, 01509-900 | |
| Bulgaria | |
| Pfizer Investigational Site | |
| Plovdiv, Bulgaria, 4004 | |
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| Sofia, Bulgaria, 1606 | |
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| Sofia, Bulgaria, 1756 | |
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| Sofia, Bulgaria, 1527 | |
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| Varna, Bulgaria, 9002 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2S 3C3 | |
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| Calgary, Alberta, Canada, T2V 2C4 | |
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| Calgary, Alberta, Canada, T2N 4N2 | |
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| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, New Brunswick | |
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| Moncton, New Brunswick, Canada, E1C 2Z3 | |
| Pfizer Investigational Site | |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
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| Oshawa, Ontario, Canada, L1J 8N8 | |
| Pfizer Investigational Site | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3T 1E2 | |
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| Montreal, Quebec, Canada, H3A 1A1 | |
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| Montreal, Quebec, Canada, H2L 4M1 | |
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| Montreal, Quebec, Canada, H3T 1M5 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| China, Guangdong | |
| Pfizer Investigational Site | |
| Guangzhou, Guangdong, China, 510060 | |
| Pfizer Investigational Site | |
| Guangzhou, Guangdong, China, 510080 | |
| China, Jiangsu | |
| Pfizer Investigational Site | |
| Nanjing, Jiangsu, China, 210002 | |
| China | |
| Pfizer Investigational Site | |
| Beijing, China, 100021 | |
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| Beijing, China, 100071 | |
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| Shanghai, China, 200032 | |
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| Shanghai, China, 200433 | |
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| Shanghai, China, 200030 | |
| France | |
| Pfizer Investigational Site | |
| Argenteuil Cedex, France, 95107 | |
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| Boulogne-Billancourt, France, 92100 | |
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| Caen Cedex 05, France, 14076 | |
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| Creil, France, 94000 | |
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| Dijon, France, 21079 | |
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| Grenoble Cedex 09, France, 38043 | |
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| Longjumeau Cedex 01, France, 91161 | |
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| Marseille Cedex 20, France, 13915 | |
| Pfizer Investigational Site | |
| NICE Cedex 2, France, 06189 | |
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| Paris, France, 75005 | |
| Pfizer Investigational Site | |
| Paris Cedex 12, France, 75571 | |
| Pfizer Investigational Site | |
| Paris Cedex 14, France, 75679 | |
| Pfizer Investigational Site | |
| Paris cedex 20, France, 75970 | |
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| St Herblain Cedex, France, 44805 | |
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| Suresnes, France, 92150 | |
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| Villejuif, France, 94805 | |
| Germany | |
| Pfizer Investigational Site | |
| Dresden, Germany, 01307 | |
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| Essen, Germany, 45122 | |
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| Grosshansdorf, Germany, 22927 | |
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| Hamburg, Germany, 22527 | |
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| Heidelberg, Germany, 69126 | |
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| Karlsruhe, Germany, 76137 | |
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| Koeln, Germany, 50937 | |
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| Muenchen, Germany, 80336 | |
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| Oldenburg, Germany, 26121 | |
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| Wiesbaden, Germany, 65199 | |
| Greece | |
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| Heraklion, Crete, Greece, 71110 | |
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| Exohi, Thessaloniki, Greece, 57010 | |
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| Athens, Greece, 11527 | |
| Hong Kong | |
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| Pokfulam, Hong Kong | |
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| Shatin, New Territories, Hong Kong | |
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| Tuen Mun, New Territories, Hong Kong | |
| Hungary | |
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| Budapest, Hungary, 1121 | |
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| Budapest, Hungary, 1125 | |
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| Debrecen, Hungary, 4032 | |
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| Farkasgyepu, Hungary, 8582 | |
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| Szekesfehervar, Hungary, 8000 | |
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| Torokbalint, Hungary, 2045 | |
| Ireland | |
| Pfizer Investigational Site | |
| Dublin 8, Ireland | |
| Pfizer Investigational Site | |
| Galway, Ireland | |
| Italy | |
| Pfizer Investigational Site | |
| Avellino, Italy, 83100 | |
| Pfizer Investigational Site | |
| Firenze, Italy, 50139 | |
| Pfizer Investigational Site | |
| Genova, Italy, 16132 | |
| Pfizer Investigational Site | |
| Lido di Camaiore (LU), Italy, 55043 | |
| Pfizer Investigational Site | |
| Lucca, Italy, 55100 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20132 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20141 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20162 | |
| Pfizer Investigational Site | |
| Monza, Italy, 20052 | |
| Pfizer Investigational Site | |
| Orbassano (TO), Italy, 10043 | |
| Pfizer Investigational Site | |
| Perugia, Italy, 06132 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00152 | |
| Pfizer Investigational Site | |
| Torino, Italy, 10126 | |
| Japan | |
| Pfizer Investigational Site | |
| Nagoya, Aichi, Japan | |
| Pfizer Investigational Site | |
| Kashiwa, Chiba, Japan | |
| Pfizer Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| Pfizer Investigational Site | |
| Akashi, Hyogo, Japan | |
| Pfizer Investigational Site | |
| Okayama-city, Okayama, Japan | |
| Pfizer Investigational Site | |
| Osakasayama-shi, Osaka, Japan | |
| Pfizer Investigational Site | |
| Sunto-gun, Shizuoka, Japan | |
| Pfizer Investigational Site | |
| Chuo-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Fukuoka, Japan | |
| Pfizer Investigational Site | |
| Tokyo, Japan | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 135-710 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Groningen, Netherlands, 9713 GZ | |
| Poland | |
| Pfizer Investigational Site | |
| Gdansk, Poland, 80-952 | |
| Pfizer Investigational Site | |
| Olsztyn, Poland, 10-357 | |
| Pfizer Investigational Site | |
| Otwock, Poland, 05-400 | |
| Pfizer Investigational Site | |
| Poznan, Poland, 60-569 | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Kazan, Russian Federation, 420029 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 115478 | |
| Pfizer Investigational Site | |
| Saint-Peterburg, Russian Federation, 197089 | |
| Pfizer Investigational Site | |
| Saint-Petersburg, Russian Federation, 197022 | |
| Pfizer Investigational Site | |
| Sochi, Russian Federation, 354057 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 198255 | |
| Spain | |
| Pfizer Investigational Site | |
| Oviedo, Asturias, Spain, 33006 | |
| Pfizer Investigational Site | |
| Badalona, Barcelona, Spain, 08916 | |
| Pfizer Investigational Site | |
| L'hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Pfizer Investigational Site | |
| Sabadell, Barcelona, Spain, 08208 | |
| Pfizer Investigational Site | |
| Pamplona, Navarra, Spain, 31008 | |
| Pfizer Investigational Site | |
| A Coru, Spain, 15006 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08003 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08035 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28046 | |
| Pfizer Investigational Site | |
| Santander, Spain, 39008 | |
| Pfizer Investigational Site | |
| Sevilla, Spain, 41013 | |
| Sweden | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 171 76 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Tainan, Taiwan, 704 | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 112 | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 100 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Pfizer Investigational Site | |
| Eastleigh, United Kingdom, SO53 2DW | |
| Pfizer Investigational Site | |
| London, United Kingdom, SW3 6JJ | |
| Pfizer Investigational Site | |
| London, United Kingdom, NW3 2QG | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE1 9RT | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M20 4BX | |
| Pfizer Investigational Site | |
| Oxford, United Kingdom, OX3 7LJ | |
| Pfizer Investigational Site | |
| Southampton, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00932893 History of Changes |
| Other Study ID Numbers: | A8081007 |
| Study First Received: | June 30, 2009 |
| Results First Received: | March 13, 2013 |
| Last Updated: | June 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Lung Neoplasms ALK gene crizotinib |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Lymphoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Docetaxel Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on June 17, 2013