Advanced Stage Solid Tumors
Conditions
Keywords
Ataxia telangiectasia mutated and Rad3-related protein inhibitor (ATRi), M6620, Solid tumors
Brief summary
The main purpose of the study was to monitor the safety of participant receiving long-term treatment of Berzosertib as monotherapy.
Interventions
DRUGBerzosertib
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.
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Treatment Related AEs | Up to 6 years | 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. |
Countries
United Kingdom
Participant flow
Pre-assignment details
1 participant from Part A1 of Study VX13-970-002 (parent study) was transferred to this study to continue receiving berzosertib.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Part A1: Berzosertib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race/Ethnicity, Customized Race-White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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
Population: Safety analysis set (SAF) included all participants who received at least 1 dose of study drug in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Berzosertib | Number of Participants With Adverse Events (AEs) and Treatment Related AEs | AEs | 1 Participants |
| Part 1: Berzosertib | Number of Participants With Adverse Events (AEs) and Treatment Related AEs | Treatment related AEs | 0 Participants |