A Multi-Center, Open-Label, Extension Study to Allow Continued Treatment of Patients Who Have Participated in Spectrum-Sponsored Clinical Studies With Belinostat
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Evaluation of safety include assessment of all SAEs, and all deaths on study or within 35 (±5) days of last study treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Wild Type UGT1A1
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.
干预措施: Belinostat (Drug)
Heterozygous UGT1A1*28
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.
干预措施: Belinostat (Drug)
Homozygous UGT1A1*28
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.
干预措施: Belinostat (Drug)
Belinostat & Atazanavir
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.
干预措施: Belinostat (Drug)
Belinostat & Atazanavir
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.
干预措施: Atazanavir (Drug)
结局指标
主要结局
Evaluation of safety include assessment of all SAEs, and all deaths on study or within 35 (±5) days of last study treatment
时间窗: 35 (±5) days after the last dose of belinostat
Frequency of adverse events (AEs \& serious adverse events (SAEs)
次要结局
未报告次要终点