Study to Continue Ceritinib Treatment for Patients in a Novartis-sponsored Study
Sponsor: Novartis Pharmaceuticals
Sponsor score: 60
ClinicalTrials ID:NCT02584933
This study allows patients who are already receiving ceritinib in a Novartis-sponsored study to continue their treatment if their doctor believes it will be beneficial.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to provide ongoing access to the medication ceritinib for patients who are currently being treated with it in a Novartis-sponsored study. If the doctor thinks that continuing the treatment will be helpful, patients can remain on ceritinib through this roll-over study.
Eligibility Criteria
Inclusion Criteria
- Currently receiving ceritinib treatment in a Novartis-sponsored study and have completed the main goals of that study.
- The doctor believes continuing ceritinib will be beneficial.
- Have followed the rules and requirements of the original study.
- Agree to attend scheduled visits and follow the treatment plan and study procedures.
- Provide written consent to participate in this roll-over study. If unable to write, consent must be documented with a witness.
Exclusion Criteria
- Have been permanently stopped from taking ceritinib in the original study for any reason.
- Have ongoing side effects that required stopping ceritinib in the original study.
- Are pregnant or breastfeeding.
- Women who can become pregnant must use effective birth control while taking ceritinib and for 3 months after stopping.
- Sexually active men must use condoms during treatment and for 3 months after stopping ceritinib, and should not father a child during this time.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group | 72703 | Fayetteville | Arkansas |
| Loma Linda University | 92354 | Loma Linda | California |
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| Maryland Oncology Hematology P A | 20850 | Rockville | Maryland |
| Essex Oncology of North Jersey PA | 07109 | Belleville | New Jersey |
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