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| Name | Class |
|---|---|
| Axis Clinicals Limited | INDUSTRY |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wild Type UGT1A1 | Other | 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. |
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| Heterozygous UGT1A1*28 | Other | 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. |
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| Homozygous UGT1A1*28 | Other | Cohort C: Homozygous, UGT1A1, Belinostat IV Dose: 750 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. |
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| Belinostat & Atazanavir | Other | Arm: Homozygous UGT1A1*28 genotype subjects with Belinostat IV & Atazanavir Dose: 750mg/ m2 (Belinostat IV), 400mg (Atazanavir) Frequency: two cycles of 21 days (Belinostat administered through Cycle 2, Day 5) Atazanavir 400mg administered Cycle 1 Day 15 to Day 21, and Cycle 2 Day 1 to Day 5 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belinostat | Drug | Patients can continue to receive belinostat treatment as described in the original study protocol or can be treated per the Investigator's standard of care. Belinostat Dose Cohort A & B: 1000mg/m2 Belinostat Dose Cohort C: 750mg/m2 Frequency: once cycle of 21 days: cycle 1, Day 1 and Cycle1, Day 2 to Day 5 Dose modifications to belinostat during treatment on this extension protocol will be in accordance with the belinostat package insert. All patients who receive at least one dose of belinostat treatment in this extension study will be followed for safety through 35 (+/-5) days after their last dose of the treatment or until all treatment related AEs have resolved or returned to Baseline/Grade I, whichever is longer, or until it is determined by the treating physician that the outcome will not change with further follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety include assessment of all SAEs, and all deaths on study or within 35 (±5) days of last study treatment | Frequency of adverse events (AEs & serious adverse events (SAEs) | 35 (±5) days after the last dose of belinostat |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erard Gilles, MD | Navitas Life Sciences Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Wayne Cancer Institute @ Providence Saint John's Health Center | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C487081 | belinostat |
| D000069446 | Atazanavir Sulfate |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
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An extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials
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| Atazanavir | Drug | Patients can continue to receive belinostat treatment as described in the original study protocol or can be treated per the Investigator's standard of care. Dose: 750mg/ m2 (Belinostat IV), 400mg (Atazanavir) Frequency: two cycles of 21 days (Belinostat administered through Cycle 2, Day 5) Atazanavir 400mg administered Cycle 1 Day 15 to Day 21, and Cycle 2 Day 1 to Day 5 Dose modifications to belinostat during treatment on this extension protocol will be in accordance with the belinostat package insert. All patients who receive at least one dose of belinostat treatment in this extension study will be followed for safety through 35 (+/-5) days after their last dose of the treatment or until all treatment related AEs have resolved or returned to Baseline/Grade I, whichever is longer, or until it is determined by the treating physician that the outcome will not change with further follow-up. |
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| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |