ATRi Transition Rollover Study

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Advanced Stage Solid Tumors

Treatments: Drug: Berzosertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03309150

MS201923-0007

2017-002354-37 (EudraCT Number)

Details and patient eligibility

About

The main purpose of the study was to monitor the safety of participant receiving long-term treatment of Berzosertib as monotherapy.

Enrollment: 1 patient

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Part A1: Berzosertib

Experimental group

Treatment:

Drug: Berzosertib