2025-523537-26-00招募中2 期
KontRASt-R: An open-label, multi-center, rollover study for participants who have been previously enrolled into a Novartis-sponsored opnurasib (JDQ443) study and are continuing to benefit from opnurasib as a single agent or in combination with other study treatments
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 26
研究概览
简要总结
The primary objective of this rollover study is to provide continued access to opnurasib, administered as monotherapy or in combination, for participants who continue to derive clinical benefit from parent protocols.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Participant is currently enrolled in a pre-defined Novartis-sponsored study and is receiving opnurasib as single agent or in combination with other study treatment.
- •Participant has received at least 6 cycles of opnurasib in a parent study
- •Participant is currently deriving clinical benefit from the study treatment, as determined by the Investigator
- •Participant has demonstrated compliance, as assessed by the Investigator, with the parent protocol requirements.
- •Participant is willing and able to comply with the scheduled visits and treatment plans.
排除标准
- •Participant has been permanently discontinued from opnurasib in the parent protocol for any reason other than enrollment in the CJDQ443B12105B study
- •Participant is not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol
- •Participant currently has unresolved toxicities for which opnurasib dosing has been interrupted in the parent study
研究组 & 干预措施
Erbitux 5 mg/mL solution for infusion
Test
干预措施: Erbitux 5 mg/mL solution for infusion (Drug)
TNO155
Test
干预措施: TNO155 (Drug)
JDQ443
Test
干预措施: JDQ443 (Drug)
VDT482
Test
干预措施: VDT482 (Drug)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (26)
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