ATRi Transition Rollover Study

NCT03309150 | Completed Phase 1 Results

• 2 other identifiers: MS201923-00072017-002354-37
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Stage Solid Tumors

Keywords

Ataxia telangiectasia mutated and Rad3-related protein inhibitor (ATRi); M6620; Solid tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Treatment Related AEs

  An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-related AEs: reasonably related to the study intervention.

  Up to 6 years

Study Arms (1)

Part A1: Berzosertib

EXPERIMENTAL

Drug: Berzosertib

Interventions

Berzosertib DRUG

Participants received intravenous infusion of Berzosertib at a dose of 126 milligrams (mg) on Days 1, 8 and 15 until disease progression or unacceptable toxicity occurred.

Also known as: M6620

Part A1: Berzosertib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies

Interventions

berzosertib

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 13, 2017
• Study Start: January 10, 2018
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-10

Locations

GB (1)