Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
NCT ID: NCT01945021
Last Updated: 2021-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2013-09-30
2020-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Crizotinib
Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
Crizotinib
Interventions
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Crizotinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* treatment-naïve or have received no more than 3 systemic treatment regimen(s)
* Positive for translocation or inversion events involving the ROS1 gene
* Negative for translocation or inversion events involving the ALK gene
* Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
* Any prior treatment (chemotherapy, radiation \[except for palliative\], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
* At least 1 measurable tumor lesion as per RECIST v1.1
* Female or male, 18 years of age or older
* ECOG performance status 0 to 1
* Adequate organ function
* Signed and dated informed consent
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
* Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment
Exclusion Criteria
* Prior therapy specifically directed against ALK or ROS1 fusion genes
* Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
* known interstitial fibrosis or interstitial lung disease
* myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
* Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade \>/=2, uncontrolled atrial fibrillation of any grade, or QTc \>470 msec
* Pregnant or breast feeding
* Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
* Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
* Evidence of active malignancy within last 3 years
18 Years
ALL
No
Sponsors
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OxOnc Development LP
OTHER
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology
Hefei, Anhui, China
Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chaoyang District, Beijing Municipality, China
The Military General Hospital of Beijing PLA / Medical Oncology Dept.
Dongcheng District, Beijing Municipality, China
307 Hospital of PLA/Department of Lung Cancer
Fengtai District, Beijing Municipality, China
Beijing Cancer Hospital, Department of Thoracic Oncology
Haidian District, Beijing Municipality, China
Chinese PLA General Hospital
Haidian District, Beijing Municipality, China
Beijing Chest Hospital
Tongzhou District, Beijing Municipality, China
Respiration department,the First Affiliated Hospital of Third Military Medical University, PLA
Shapingba District, Chongqing Municipality, China
Fujian Province Oncology Hospital
Fuzhou, Fujian, China
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Hunan Provincial Tumor Hospital/Division of Oncology
Changsha, Hunan, China
Department of Oncology, Jilin Provincial Cancer Hospital
Changchun, Jilin, China
The affiliated hospital of medical college Qingdao University / Medical oncology department
Qingdao, Shandong, China
Department of Pulmonary Medicine, Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital/Lung cancer clinical center
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University / Respiratory Department
Xuhui District, Shanghai Municipality, China
Oncology Department, West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Province Cancer Hospital/Department of Pulmonary Tumor
Chengdu, Sichuan, China
Department of Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital
Hexi District, Tianjin Municipality, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Aichi Cancer Center Hospital
Aichi, , Japan
National Cancer Center Hospital East
Chiba, , Japan
NHO Shikoku Cancer Center
Ehime, , Japan
NHO Kyushu Cancer Center
Fukuoka, , Japan
Hyogo Cancer Center
Hyōgo, , Japan
Tohoku University Hospital
Miyagi, , Japan
Kinki University Hospital
Osaka, , Japan
Osaka City General Hospital
Osaka, , Japan
Cancer Institute Hospital of JFCR
Tokyo, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University, Severance Hospital
Seoul, , South Korea
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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Wu YL, Yang JC, Kim DW, Lu S, Zhou J, Seto T, Yang JJ, Yamamoto N, Ahn MJ, Takahashi T, Yamanaka T, Kemner A, Roychowdhury D, Paolini J, Usari T, Wilner KD, Goto K. Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 May 10;36(14):1405-1411. doi: 10.1200/JCO.2017.75.5587. Epub 2018 Mar 29.
Other Identifiers
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OO 12-01
Identifier Type: -
Identifier Source: org_study_id
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