Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

NCT01945021

Last updated date
Study Location
The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology
Hefei, Anhui, 230022, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Cancer, ROS1 Proto Oncogene, Crizotinib
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Non Small Cell Lung Cancer, ROS1 Proto Oncogene, CrizotinibPhase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC NCT01945021
  1. Hefei, Anhui
  2. Chaoyang District, Beijing
  3. Dongcheng District, Beijing
  4. Fengtai District, Beijing
  5. Haidian District, Beijing
  6. Haidian District, Beijing
  7. Tongzhou District, Beijing
  8. Shapingba District, Chongqing
  9. Fuzhou, Fujian
  10. Guangzhou, Guangdong
  11. Guangzhou, Guangdong
  12. Guangzhou, Guangdong
  13. Changsha, Hunan
  14. Changchun, Jilin
  15. Qingdao, Shandong
  16. Shanghai, Shanghai
  17. Shanghai, Shanghai
  18. Shanghai, Shanghai
  19. Xuhui District, Shanghai
  20. Chengdu, Sichuan
  21. Chengdu, Sichuan
  22. Hexi District, Tianjin
  23. Hangzhou, Zhejiang
  24. Hangzhou, Zhejiang
  25. Hangzhou, Zhejiang
  26. Sunto-gun, Shizuoka
  27. Aichi,
  28. Chiba,
  29. Ehime,
  30. Fukuoka,
  31. Hyogo,
  32. Miyagi,
  33. Osaka,
  34. Osaka,
  35. Tokyo,
  36. Tokyo,
  37. Seoul,
  38. Seoul,
  39. Seoul,
  40. Seoul,
  41. Taichung,
  42. Tainan,
  43. Taipei,
  44. Taipei,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Non Small Cell Lung Cancer
  • ROS1 Proto Oncogene
  • Crizotinib
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
 (submitted: July 28, 2016)
129
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2013)
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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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