A Study to Evaluate the Effect of MK-8669 (Ridaforolimus) on QTc Interval in Participants With Advanced Cancer (MK-8669-037)
2019年5月1日 更新者：Merck Sharp & Dohme LLC
A Clinical Trial to Assess the Effect of Ridaforolimus (AP23573; MK-8669) on QTc Interval in Patients
To assess the potential for ridaforolimus to prolong the QTc interval (an effect on the electrical activity of the heart) in participants with advanced cancer.
This study will be done in 2 parts.
Part 1 (Pt 1) will evaluate the effect of a single 100 mg dose of ridaforolimus on QT interval in participants with advanced cancer.
Fridericias's correction (QTcF) will be used.
In Part 2 (Pt 2), participants will receive ridaforolimus at the current therapeutic dose (40 mg x 5 days).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
23
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participant must have metastatic or locally advanced cancer which has failed to respond to standard therapy or no therapy exists.
- If the participant is a female, she must be postmenopausal or if she is of childbearing potential she must have blood pregnancy tests during the study and be willing to use 2 methods of contraception.
- If the participant is male and has female partners of child-bearing potential, he must agree to use a medically acceptable method of contraception during the study and for 30 days after the last dose of study drug.
Exclusion Criteria:
- Participant has had chemotherapy, radiotherapy or biological therapy within the past 4 weeks.
- Participant is currently receiving other anti-cancer therapy.
- Participant is currently participating or has participated in a study with an investigation drug or device within the last 30 days.
- Participant has a primary central nervous system tumor or active brain metastases.
- Participant has a psychiatric disorder.
- Participant uses illegal drugs.
- Participant is pregnant or breastfeeding.
- Participant is known to be human immunodeficiency virus (HIV) positive.
- Participant has a known history of Hepatitis B or C.
- Participant has newly diagnosed diabetes.
- Participant has an active infection.
- Participant is unable to swallow capsules.
- Participant has received a blood transfusion with one week of study entry.
- Participant has a history of cardiac problems including heart failure, myocardial infarction, unstable angina, congestive heart failure or cardiac arrhythmia.
- Participant has a known sensitivity to the components of the study drug.
- Participant has not adequately recovered from any prior surgical procedure.
- Participant does not agree to refrain from use of herbal remedies and consumption of grapefruit juice for 2 weeks prior to and during the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Pt 1. Placebo/Ridaforolimus 100 mg; Pt 2. Ridaforolimus 40 mg
[Pt 1, Day 1]: Participants received a single dose of placebo (10 oral tablets) on Day 1 of Part 1. [Pt 1, Day 2]: Following completion of Part 1 / Day 1, participants received a single dose of ridaforolimus 100 mg (10 x 10 mg oral tablets) on Day 2 of Part 1.
Following completion of Part 1 / Day 2, participants entered a washout period of ≥5 days before the first dose Part 2. [Pt 2]: Following completion of Part 1, participants received ridaforolimus 40 mg (4 x 10 mg oral tablets) given once daily (QD) for 5 consecutive days followed by 2 days off-drug.
|
Part 1: A single oral dose of 100 mg ridaforolimus (10 x 10 mg tablets) was given on Day 2.
其他名称：
Part 2 (optional): Ridaforolimus 40 mg (4 x 10 mg tablets) was received on a regimen of daily oral doses for 5 consecutive days followed by 2 days off-drug.
其他名称：
Part 1: A single oral dose of placebo (10 x placebo tablets) was given on Day 1.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 0.5 Hours
大体时间：Baseline and 0.5 hours post-dose on Days 1 & 2 of Part 1
|
The mean change from baseline (CFB) in QTcF at 0.5 hours post-dose was assessed.
At baseline (pre-dose) and at 0.5 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability.
The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant.
Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing.
Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.
|
Baseline and 0.5 hours post-dose on Days 1 & 2 of Part 1
|
|
Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 1 Hour
大体时间：Baseline and 1 hour post-dose on Days 1 & 2 of Part 1
|
The mean change from baseline (CFB) in QTcF at 1 hour post-dose was assessed.
At baseline (pre-dose) and at 1 hour post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability.
The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant.
Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing.
Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.
|
Baseline and 1 hour post-dose on Days 1 & 2 of Part 1
|
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Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 2 Hours
大体时间：Baseline and 2 hours post-dose on Days 1 & 2 of Part 1
|
The mean change from baseline (CFB) in QTcF at 2 hours post-dose was assessed.
At baseline (pre-dose) and at 2 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability.
The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant.
Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing.
Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.
|
Baseline and 2 hours post-dose on Days 1 & 2 of Part 1
|
|
Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 3 Hours
大体时间：Baseline and 3 hours post-dose on Days 1 & 2 of Part 1
|
The mean change from baseline (CFB) in QTcF at 3 hours post-dose was assessed.
At baseline (pre-dose) and at 3 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability.
The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant.
Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing.
Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.
|
Baseline and 3 hours post-dose on Days 1 & 2 of Part 1
|
|
Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 4 Hours
大体时间：Baseline and 4 hours post-dose on Days 1 & 2 of Part 1
|
The mean change from baseline (CFB) in QTcF at 4 hours post-dose was assessed.
At baseline (pre-dose) and at 4 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability.
The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant.
Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing.
Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.
|
Baseline and 4 hours post-dose on Days 1 & 2 of Part 1
|
|
Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 6 Hours
大体时间：Baseline and 6 hours post-dose on Days 1 & 2 of Part 1
|
The mean change from baseline (CFB) in QTcF at 6 hours post-dose was assessed.
At baseline (pre-dose) and at 6 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability.
The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant.
Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing.
Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.
|
Baseline and 6 hours post-dose on Days 1 & 2 of Part 1
|
|
Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 8 Hours
大体时间：Baseline and 8 hours post-dose on Days 1 & 2 of Part 1
|
The mean change from baseline (CFB) in QTcF at 8 hours post-dose was assessed.
At baseline (pre-dose) and at 8 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability.
The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant.
Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing.
Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.
|
Baseline and 8 hours post-dose on Days 1 & 2 of Part 1
|
|
Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 10 Hours
大体时间：Baseline and 10 hours post-dose on Days 1 & 2 of Part 1
|
The mean change from baseline (CFB) in QTcF at 10 hours post-dose was assessed.
At baseline (pre-dose) and at 10 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability.
The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant.
Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing.
Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.
|
Baseline and 10 hours post-dose on Days 1 & 2 of Part 1
|
|
Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 24 Hours
大体时间：Baseline and 24 hours post-dose on Days 1 & 2 of Part 1
|
The mean change from baseline (CFB) in QTcF at 24 hours post-dose was assessed.
At baseline (pre-dose) and at 24 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability.
The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant.
Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing.
Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.
|
Baseline and 24 hours post-dose on Days 1 & 2 of Part 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
大体时间：Up to 7 months
|
The number of participants experiencing an AE was assessed.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Participants experiencing AEs were counted under the treatment they received when the AE occurred.
Participants experiencing AEs during the washout period between Part 1 and Part 2 are counted in the "Pt 1, Day 2. Ridaforolimus 100 mg" arm.
|
Up to 7 months
|
|
Number of Participants Discontinuing Study Treatment Due to an Adverse Event
大体时间：Up to 6 months
|
The number of participants discontinuing study treatment due to an AE was assessed.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Participants discontinuing study treatment due to an AE were counted as discontinuing under the treatment they received when the AE occurred.
|
Up to 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2009年4月28日
初级完成 (实际的)
2009年10月30日
研究完成 (实际的)
2010年4月30日
研究注册日期
首次提交
2009年3月31日
首先提交符合 QC 标准的
2009年4月1日
首次发布 (估计)
2009年4月2日
研究记录更新
最后更新发布 (实际的)
2019年5月6日
上次提交的符合 QC 标准的更新
2019年5月1日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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