Clinical trial · Interventional
Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials
A Multi-Center, Open-Label, Extension Study to Allow Continued Treatment of Patients Who Have Participated in Spectrum-Sponsored Clinical Studies With Belinostat
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atazanavir | Drug | — | UNRESOLVED |
| Belinostat | Drug | Belinostat | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Wild Type UGT1A1
- description
- Cohort A: Wild Type, UGT1A1, Belinostat IV Dose: 1000 mg/m2 Frequency: 30-minute infusion once daily from Day 1 to Day 5 of a 21-day cycle. Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.
- interventionNames
- Drug: Belinostat
- type
- OTHER
- label
- Heterozygous UGT1A1*28
- description
- Cohort B: Heterozygous, UGT1A1, Belinostat IV Dose: 1000 mg/m2 Frequency: 30-minute infusion once daily from Day 1 to Day 5 of a 21-day cycle. Duration: Up to five 21-day cycles (15 weeks) Treatment Period: Up to a total of six 21-day cycles (18 weeks) of treatment total from both the original study protocol and this extension protocol.
- interventionNames
- Drug: Belinostat
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available