Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02584933|
Recruitment Status : Recruiting
First Posted : October 23, 2015
Last Update Posted : May 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|ALK Positive Malignancies||Drug: ceritinib||Phase 4|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||252 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib|
|Actual Study Start Date :||December 11, 2015|
|Estimated Primary Completion Date :||December 14, 2020|
|Estimated Study Completion Date :||December 31, 2021|
The starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent ceritinib study at the time of the rollover.
hard gelatin capsule or hard tablet for oral use up to 750 mg
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Until no patients are left on study up to 5 years ]To collect safety data: adverse events and serious adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584933
|Contact: Novartis Pharmaceuticals||1-888-669-6682|
|Contact: Novartis Pharmaceuticals||+41613241111|