Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
NCT01945021
ABOUT THIS STUDY
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- Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
- 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
- Current treatment on another therapeutic clinical trial
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC | |||
Official Title ICMJE | Phase II, Open Label, Single Arm Study of the Efficacy and Safety of Crizotinib in East Asian Patients With Advanced ALK-Negative NSCLC Harboring a Translocation or Inversion Involving the c-ROS Oncogene (ROS1) Locus | |||
Brief Summary | To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: Crizotinib
Other Name: Xalkori | |||
Study Arms ICMJE | Experimental: Crizotinib
Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib Intervention: Drug: Crizotinib | |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 129 | |||
Original Estimated Enrollment ICMJE | 110 | |||
Actual Study Completion Date ICMJE | January 22, 2020 | |||
Actual Primary Completion Date | July 31, 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China, Japan, Korea, Republic of, Taiwan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01945021 | |||
Other Study ID Numbers ICMJE | OO 12-01 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | OxOnc Development LP | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |