ATRi Transition Rollover Study

November 15, 2023 updated by: Merck KGaA, Darmstadt, Germany

A Rollover Study to Provide Continued Treatment With M6620

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sutton, United Kingdom
        • Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: M6620 Monotherapy or Combination Therapy
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.
Drug: Carboplatin
Participant will receive carboplatin intravenous infusion as a combination therapy on Day 1 of the study.
Drug: Paclitaxel
Participant will receive paclitaxel intravenous infusion as a combination therapy on Day 1, 8 and 15 of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: Up to Day 43
Up to Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

December 15, 2023

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS201923-0007
  • 2017-002354-37 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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