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

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology
Hefei, Anhui, 230022 China
Contact
1-800-718-1021
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

NCT01945021
Pfizer
Active, not recruiting
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

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Pfizer Clinical Trials Contact Center

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[email protected]

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NSCLC, Crizotinib, ALK Gene Rearrangement or ROS1 Gene Rearrangement
NCT03718117
All Genders
18+
Years
Multiple Sites
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 SummaryTo 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 28, 2016)
129
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2013)
110
Estimated Study Completion Date  ICMJE April 1, 2020
Actual Primary Completion DateJuly 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE OxOnc Development LP
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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