ATRi Transition Rollover Study

Advanced Stage Solid Tumors Clinical Trial

Official title:

A Rollover Study to Provide Continued Treatment With M6620

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03309150
• Other study ID #: MS201923-0007
• Secondary ID: 2017-002354-37
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 10, 2018
• Est. completion date: December 15, 2023

Study information

• Verified date: November 2023
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Stage Solid Tumors

Intervention

Drug:
• M6620
Participant will either receive M6620 intravenously as a monotherapy on Day 1, 8 and 15 OR as a combination therapy on Day 2 and 9 of the study.
• Carboplatin
Participant will receive carboplatin intravenous infusion as a combination therapy on Day 1 of the study.
• Paclitaxel
Participant will receive paclitaxel intravenous infusion as a combination therapy on Day 1, 8 and 15 of the study.

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (Version 4.03)		Up to Day 43

External Links

•   Trial Awareness and Transparency website