Trial Outcomes & Findings for ATRi Transition Rollover Study (NCT NCT03309150)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

1 participants

Primary outcome timeframe

Up to 6 years

Results posted on

2024-11-29

Participant Flow

1 participant from Part A1 of Study VX13-970-002 (parent study) was transferred to this study to continue receiving berzosertib.

Participant milestones

Participant milestones
Measure	Part A1: 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.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ATRi Transition Rollover Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A1: Berzosertib n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Race-White	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Population: Safety analysis set (SAF) included all participants who received at least 1 dose of study drug in this study.

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.

Outcome measures

Outcome measures
Measure	Part 1: Berzosertib n=1 Participants 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.
Number of Participants With Adverse Events (AEs) and Treatment Related AEs AEs	1 Participants
Number of Participants With Adverse Events (AEs) and Treatment Related AEs Treatment related AEs	0 Participants

Adverse Events

Part A1: Berzosertib

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A1: Berzosertib n=1 participants at risk 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.
Cardiac disorders Coronary artery disease	100.0% 1/1 • Number of events 1 • Up to 6 years
Gastrointestinal disorders Dysphagia	100.0% 1/1 • Number of events 1 • Up to 6 years
Metabolism and nutrition disorders Hypokalaemia	100.0% 1/1 • Number of events 3 • Up to 6 years
Infections and infestations Oral candidiasis	100.0% 1/1 • Number of events 1 • Up to 6 years
Infections and infestations Urinary tract infection	100.0% 1/1 • Number of events 1 • Up to 6 years

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place