Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT04184869
Brief Summary:
This is an open-label, extension protocol designed to allow patients to continue to receive belinostat treatment after they have completed the protocol-specified assessments and procedures in a Spectrum sponsored belinostat study and have not met the criteria for treatment discontinuation in those studies. This extension of belinostat treatment allowance is not a part of the primary efficacy assessments for those trials. The extension is intended to provide all possible benefits to patients who are having a positive response to belinostat and must be under the Investigator's care. The additional treatment is optional and voluntary.
Detailed Description:
This is an open-label, extension protocol designed to allow patients to continue to receive belinostat treatment after they have completed the protocol-specified assessments and procedures in a Spectrum sponsored belinostat study and have not met the criteria for treatment discontinuation in those studies. This extension of belinostat treatment allowance is not a part of the primary efficacy assessments for those trials. The extension is intended to provide all possible benefits to patients who are having a positive response to belinostat and must be under the Investigator's care. The additional treatment is optional and voluntary.
This protocol will be available for all patients who have completed the protocol-specified assessments and procedures in Spectrum sponsored belinostat studies. Patients can receive belinostat treatment according to the treatment schedule that is being administered at the time they complete participation in the original clinical study protocol or can be treated per the Investigator's standard of care. Doe modifications during treatment on this extension protocol will be in accordance with the U.S. package insert.
Safety will continue to be followed during the extended belinostat treatment. Therapeutic benefits or efficacy will be followed to the extent that is evaluated according to the institution's standard of care.
Study:
NCT04184869
Study Brief:
Protocol Section:
NCT04184869