Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials
Completed · Phase 1
Conditions studied: Solid Tumor, Hematological Malignancies
In brief
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.
Key facts
- Study ID
- NCT04184869
- Run by
- Acrotech Biopharma Inc.
- People needed
- 8
- Starts
- 2019-08-05
- Expected to finish
- 2023-03-31
- Last updated by the study team
- 2023-05-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient has participated in, and completed, a Spectrum-sponsored clinical study with belinostat and did not meet the treatment discontinuation criteria in the study
- Investigator considers this extended belinostat treatment is appropriate for patient, and patient is suitable for the treatment
- Patient agrees to continue belinostat treatment as defined in the original clinical study protocol
- Patient must be willing to give written Informed Consent and must be able to adhere to dosing and visit schedules and meet study requirements
- Patient is willing to practice two forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of the study drug
You may not qualify if…
- Patient has an active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive belinostat benefit
- Patient is receiving any other treatment modalities including investigational products for their malignancy
- Patient has any medical or non-medical condition that may not be suitable for belinostat treatment, as determined by the investigator and according to the US package insert
- Patient is pregnant or is breastfeeding
Where it is running
- John Wayne Cancer Institute @ Providence Saint John's Health Center — Santa Monica, California, United States
Full record on ClinicalTrials.gov
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