An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 主要终点
- Number of Participants Who Experienced an Adverse Event
研究概览
简要总结
To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for whom a clinical benefit has been established in a prior parent trial (MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or in those who remain in long-term follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have participated on a deforolimus (ridaforolimus) parent trial
- •Must have derived a clinical benefit from the parent trial
- •Is not on any other anti-cancer treatment(s) unless the therapy was allowed on the parent protocol
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 if the participant is scheduled to receive treatment with deforolimus; no requirement if the participant is included for follow-up purposes only
- •Participant of childbearing potential must have a negative pregnancy test within 7 days prior to screening and must use approved contraceptive from screening until 30 days after the last dose of study drug
- •Signed informed consent
排除标准
- •Has not participated on a parent trial
- •Women who are to receive study drug who are pregnant or lactating
- •Any condition in the Investigator's judgment that renders the participant unable to fully understand and provide informed consent and/or comply with the protocol
研究组 & 干预措施
Ridaforolimus 10 mg Days 1-5
Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus intravenous (IV) infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Tablet (Drug)
Ridaforolimus 10 mg Days 1-5
Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus intravenous (IV) infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Intravenous (IV) Infusion (Drug)
Ridaforolimus 10 mg Days 1-6
Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Tablet (Drug)
Ridaforolimus 10 mg Days 1-6
Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Intravenous (IV) Infusion (Drug)
Ridaforolimus 20 mg Days 1-5
Ridaforolimus 20 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Tablet (Drug)
Ridaforolimus 20 mg Days 1-5
Ridaforolimus 20 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Intravenous (IV) Infusion (Drug)
Ridaforolimus 30 mg Days 1-5
Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Tablet (Drug)
Ridaforolimus 30 mg Days 1-5
Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Intravenous (IV) Infusion (Drug)
Ridaforolimus 40 mg Days 1-5
Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Tablet (Drug)
Ridaforolimus 40 mg Days 1-5
Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
干预措施: Ridaforolimus Intravenous (IV) Infusion (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event
时间窗: Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)
An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who experienced an adverse event is presented.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
时间窗: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who discontinued study drug due to an adverse event is presented.
次要结局
- Duration of Response (DOR)(Up to approximately 2961 days (through data cut-off date of 03 Apr 2017))
- Progression-free Survival (PFS)(Up to approximately 2961 days (through data cut-off date of 03 Apr 2017))
- Overall Survival (OS)(Up to approximately 2991 days (through data cut-off date of 03 Apr 2017))