ATRi Transition Rollover Study

NCT ID: NCT03309150

Last Updated: 2024-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2024-01-26

Brief Summary

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

Detailed Description

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Conditions

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Advanced Stage Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A1: Berzosertib

Group Type EXPERIMENTAL

Berzosertib

Intervention Type 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.

Interventions

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Berzosertib

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.

Intervention Type DRUG

Other Intervention Names

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M6620

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

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Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2017-002354-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MS201923-0007

Identifier Type: -

Identifier Source: org_study_id