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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 March 14, 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.
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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

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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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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