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.
Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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