Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments

Официальное название

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

Обзор

The purpose of this study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined Novartis-sponsored opnurasib studies and to continue to assess safety in these participants.

Подробное описание

Screening occurs on the same day as the parent study's End of Treatment visit, with informed consent and eligibility confirmation required before enrollment. Eligible participants start treatment within seven days and return for scheduled visits for drug resupply, safety monitoring, and confirmation of clinical benefit. Sites are expected to follow their local practice regarding the method and frequency of the assessments used to assess clinical benefit for the patient. Treatment continues until disease progression or other discontinuation criteria, and safety follow-up lasts 30-150 days depending on the last drug received. The study will remain open for up to three years from first participant visit or until all participants discontinue.

Вмешательства

• Препарат Opnurasib
  Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
• Препарат TNO155
  Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
• Препарат trametinib
  Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
• Биопрепарат cetuximab
  Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
• Биопрепарат tislelizumab
  Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.

Первичные конечные точки

• Number of participants receiving opnurasib as single agent or in combination with other study treatments [Срок оценки: Assessed up to approximately 3 years]
• Duration of exposure to study treatment [Срок оценки: Assessed up to approximately 3 years]

Вторичные конечные точки (2)

• Incidence rate of Adverse Events (AEs) [Срок оценки: Assessed up to approximately 3 years]
• Number of participants with dose adjustments [Срок оценки: Assessed up to approximately 3 years]

Критерии участия

Критерии включения

• 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.
• Participants currently receiving treatment in one of the KontRASt studies, including those who have not experienced disease progression or who are continuing treatment beyond initial disease progression, may be eligible to enroll in the rollover study if, in the Investigator's judgment, they are expected to continue deriving clinical benefit from treatment with opnurasib (alone or in combination). Clinical benefit, as assessed by the Investigator, may be reflected by delayed disease progression, improvement in disease-related symptoms, improvement in overall quality of life, or a combination of these factors.

Критерии исключения

• 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.
• Participant has known actionable mutations, such as EGFR-sensitizing mutation, ALK rearrangement, or others, identified during the participation in the parent trial for which there are available treatment options.

Other protocol-defined inclusion/exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Япония · 2 центра

• Novartis Investigative Site — Kashiwa
• Novartis Investigative Site — Koto Ku

Бельгия · 1 центр

• Novartis Investigative Site — Sint-Niklaas

Канада · 1 центр

• Novartis Investigative Site — Montreal

Китай · 1 центр

• Novartis Investigative Site — Гуанчжоу

Малайзия · 1 центр

• Novartis Investigative Site — Kuching

South Korea · 1 центр

• Novartis Investigative Site — Seoul

Идентификаторы

NCT: NCT07468071 · CJDQ443B12105B · 2025-523537-26-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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