A Phase 1 interventional study of Berzosertib in Advanced Stage Solid Tumors, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Treatment
The main purpose of the study was to monitor the safety of participant receiving long-term treatment of Berzosertib as monotherapy.
Exclusion Criteria:
Drug: 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.
Also known as: M6620
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.
Time frame: Up to 6 years
| Milestone | Part A1: Berzosertib |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
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.
| Participants | Part 1: Berzosertib |
|---|---|
| AEs | 1 |
| Treatment related AEs | 0 |
Collected over Up to 6 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A1: Berzosertib | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Part A1: Berzosertib |
|---|---|
| Coronary artery diseaseCardiac disorders | 1/1 |
| DysphagiaGastrointestinal disorders | 1/1 |
| HypokalaemiaMetabolism and nutrition disorders | 1/1 |
| Oral candidiasisInfections and infestations | 1/1 |
| Urinary tract infectionInfections and infestations | 1/1 |
| Age, Categorical(Participants) | Part A1: Berzosertib |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Part A1: Berzosertib |
|---|---|
| Female | 0 |
| Male | 1 |
| Race/Ethnicity, Customized(Participants) | Part A1: Berzosertib |
|---|---|
| Race-White | 1 |
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Merck KGaA, Darmstadt, Germany