NeoplasmsNCT02824094
Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC
A study testing crizotinib in people with Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Pfizer at 4 sites in Japan.
Trial summary
Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- crizotinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 4 sitesJapan
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
- Positive for translocation or inversion events involving the ROS1 gene as determined by protocol defined test.
- ECOG performance status 0 to 2.
- Adequate organ function
- Patients with brain metastases are eligible if neurologically stable for at least 2 weeks and have no ongoing requirement for corticosteroids.
- Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after the last dose of crizotinib.
Who cannot join
- Currently receiving crizotinib or any investigational products.
- Prior therapy specifically directed against ROS1 fusion genes including crizotinib.
- Carcinomatous meningitis or leptomeningeal disease.
- Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.
- Ongoing uncontrolled congestive heart failure (CHF) and any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
- Ongoing cardiac dysrhythmias of CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QTc more than 480 msec.
Show all 9Show fewer
- History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
- Pregnant female patients; breastfeeding female patients.
- Use of drugs or foods including known potent CYP3A4 inhibitors, known potent CYP3A4 inducers and CYP3A4 substrates with narrow therapeutic indices
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Aichi cancer center central hospital
Nagoya, Aichi-ken, 464-8681
About this study
Official title: Crizotinib (Xalkori (Registered)) Expanded Access Protocol For The Treatment Of Japanese Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Ros1 Oncogene
Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene.
- Conditions
- Neoplasms, Carcinoma, Non-Small-Cell Lung
- Being tested
- crizotinib
- Keywords
- Expanded Access Protocol, crizotinib, Xalkori, ROS1, Japanese, A8081064
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crizotinibDrug
Crizotinib, 250 mg BID, will be administered orally on a continuous daily dosing schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824094
- Sponsor's protocol ID
- A8081064
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crizotinib (Xalkori (Registered)) Expanded Access Protocol For The Treatment Of Japanese Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Ros1 Oncogene
- ClinicalTrials.gov ID
- NCT02824094
- Acronym / sponsor ID
- A8081064
- Conditions
- Neoplasms, Carcinoma, Non-Small-Cell Lung
- Keywords
- Expanded Access Protocol, crizotinib, Xalkori, ROS1, Japanese, A8081064
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene.
Study design
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
- Positive for translocation or inversion events involving the ROS1 gene as determined by protocol defined test.
- ECOG performance status 0 to 2.
- Adequate organ function
- Patients with brain metastases are eligible if neurologically stable for at least 2 weeks and have no ongoing requirement for corticosteroids.
Key exclusion criteria (9 listed)
- Currently receiving crizotinib or any investigational products.
- Prior therapy specifically directed against ROS1 fusion genes including crizotinib.
- Carcinomatous meningitis or leptomeningeal disease.
- Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.
- Ongoing uncontrolled congestive heart failure (CHF) and any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crizotinibCrizotinib, 250 mg BID, will be administered orally on a continuous daily dosing schedule | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crizotinib in people with Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Pfizer at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.