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A Rollover Protocol of Dacomitinib For Patients In Japan

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Kanazawa University Hospital
Kanazawa City, Ishikawa, 9208641 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
NSCLC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients who received dacomitinib on another clinical trial in Japan

- Evidence of a personally signed and dated informed consent document

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients who meet one or more study withdrawal criteria on the prior study

- Participation in other studies involving other investigational drug(s) during study
participation

NCT02382796
Pfizer
Active, not recruiting
A Rollover Protocol of Dacomitinib For Patients In Japan

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[email protected]

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A Rollover Protocol of Dacomitinib For Patients In Japan
Treatment Access Protocol For Patients Previously Treated With Dacomitinib On A Clinical Trial In Japan
The purpose of this study to permit continued access to dacomitinib for patients who participated in other dacomitinib monotherapy treatment protocols in Japan and have the potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib treatment.
The intention of the study is to allow continued use of dacomitinib in Japan for patients on closed dacomitinib clinical trials and who continue to experience clinical benefit.
Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
NSCLC
Drug: Dacomitinib
Starting at the current dose level in the prior study. Dose reductions and re-escalations are allowed based on tolerability. Patients may continue to be treated with dacomitinib on this protocol as long as there is evidence of clinical benefit in the judgment of the investigator.
Experimental: Dacomitinib
3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing
Intervention: Drug: Dacomitinib
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
6
May 31, 2019
May 31, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who received dacomitinib on another clinical trial in Japan
  • Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

  • Patients who meet one or more study withdrawal criteria on the prior study
  • Participation in other studies involving other investigational drug(s) during study participation
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT02382796
A7471055
No
Not Provided
Plan to Share IPD: No
Pfizer
Pfizer
Not Provided
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 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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