Clinical Trial: NCT04768296
Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
| Information Provided By: | EMD Serono |
| Last Update Posted: | 2024-09-26 |
Study Overview
Brief Summary
The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.
Official Title
A Phase II, Open-label, Single-arm Study of Berzosertib (M6620) in Combination With Topotecan in Participants With Relapsed Platinum-resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
Conditions
Small-cell Lung Cancer
Intervention / Treatment
- Drug: Berzosertib
- Drug: Berzosertib
- Drug: Topotecan
Other Study ID Numbers
- MS201923_0050
- 2020-004231-25
Start Date (Actual)
2021-03-29
Primary Completion Date (Actual)
2023-07-21
Study Completion Date (Actual)
2023-07-21
Enrollment (Actual)
76
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
| Information Provided By: | EMD Serono |
| Last Update Posted: | 2024-09-26 |
Study Overview
Brief Summary
The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.
Official Title
A Phase II, Open-label, Single-arm Study of Berzosertib (M6620) in Combination With Topotecan in Participants With Relapsed Platinum-resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
Conditions
Small-cell Lung Cancer
Intervention / Treatment
- Drug: Berzosertib
- Drug: Berzosertib
- Drug: Topotecan
Other Study ID Numbers
- MS201923_0050
- 2020-004231-25
Start Date (Actual)
2021-03-29
Primary Completion Date (Actual)
2023-07-21
Study Completion Date (Actual)
2023-07-21
Enrollment (Actual)
76
Study Type
Interventional
Phase
Phase 2