ATRi Transition Rollover Study

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to monitor the safety of participant receiving long-term treatment of M6620 as monotherapy or in combination with carboplatin and paclitaxel.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Participants ongoing treatment in Vertex study VX13-970-002.

• Participant must be able to understand and provide written informed consent.

• Participant must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.

Exclusion Criteria:

• Participants experiencing disease progression or unacceptable toxicity at the time of transition into the this study.