Non-small Cell Lung CancerNCT01597258
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
An observational study of Non-small Cell Lung Cancer, run by Pfizer.
Trial summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Crizotinib (Xalkori)
- Type of treatment
- Pill or oral medicine
- How many people
- 2,029 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2012to 16 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients whom an investigator involving A8081031 prescribes the Crizotinib (XALKORI).
Who may be able to join
- All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)
Who cannot join
- Patients not administered XALKORI in spite of enrolled.
About this study
Official title: SPECIAL INVESTIGATION OF XALKORI FOR NSCLC (REGULATORY POST MARKETING COMMITMENT PLAN)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Read the detailed description
All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Crizotinib (Xalkori)
- Keywords
- Safety, All cases surveillance in Japan, ALK-positive unresectable advanced and/or recurrent non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crizotinib (Xalkori)Drug
Also called XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg
XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "
| Study group | Role | What they receive |
|---|---|---|
| Crizotinib (Xalkori) | Not described Receives: Drug: Crizotinib (Xalkori) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Drug Reactions
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician.
Measured: 52 weeks
Secondary outcomes (1)
Objective Response Rate (ORR) at 52 Weeks
Clinical effectiveness of XALKORI Capsules was assessed as "complete response (CR)", "partial response (PR)", "stable disease (SD)", "progressive disease (PD)", or "indeterminate" by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study start29 May 2012
- Primary completion16 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,029 participants (actual)
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
- NCT01597258
- Sponsor's protocol ID
- A8081031
- Status last verified
- Sep 2019
- First submitted
- 10 May 2012
- Last updated
- 13 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Ueno N, Banno S, Endo Y, Tamura M, Sugaya K, Hashigaki S, Ohki E, Yoshimura A, Gemma A. Treatment status and safety of crizotinib in 2028 Japanese patients with ALK-positive NSCLC in clinical settings. Jpn J Clin Oncol. 2019 Jul 1;49(7):676-686. doi: 10.1093/jjco/hyz049.
PubMed 31008509
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECIAL INVESTIGATION OF XALKORI FOR NSCLC (REGULATORY POST MARKETING COMMITMENT PLAN)
- ClinicalTrials.gov ID
- NCT01597258
- Acronym / sponsor ID
- A8081031
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Safety, All cases surveillance in Japan, ALK-positive unresectable advanced and/or recurrent non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,029 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 May 2012 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed description
All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crizotinib (Xalkori) | – | Drug: Crizotinib (Xalkori) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients whom an investigator involving A8081031 prescribes the Crizotinib (XALKORI).
Key inclusion criteria (1 listed)
- All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)
Key exclusion criteria (1 listed)
- Patients not administered XALKORI in spite of enrolled.
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 |
|---|---|---|
| Crizotinib (Xalkori)Also: XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mgXALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. " | Drug | Crizotinib (Xalkori) |
Primary outcome
Number of Participants With Adverse Drug Reactions
Time frame: 52 weeks
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician.
1 secondary outcome
Objective Response Rate (ORR) at 52 Weeks
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31008509Ueno N, Banno S, Endo Y, Tamura M, Sugaya K, Hashigaki S, Ohki E, Yoshimura A, Gemma A. Treatment status and safety of crizotinib in 2028 Japanese patients with ALK-positive NSCLC in clinical settings. Jpn J Clin Oncol. 2019 Jul 1;49(7):676-686. doi: 10.1093/jjco/hyz049.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Pfizer.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Participants With Adverse Drug Reactions (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01597258, which also lists 1 linked publication.
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 13 Sep 2019.