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

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NCT01945021

Last updated on March 25, 2018
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FOR MORE INFORMATION
Study Location
The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology
Hefei, Anhui, 230022 China
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
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
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
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non Small Cell Lung Cancer
  • ROS1 Proto Oncogene
  • Crizotinib
Drug: Crizotinib
Other Name: Xalkori
Experimental: Crizotinib
Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
Intervention: Drug: Crizotinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
129
December 28, 2018
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Japan,   Korea, Republic of,   Taiwan
 
 
NCT01945021
OO 12-01
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
OxOnc Development LP
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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