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)

Trial Information
Who is this study for? Adult patients with Small-Cell Lung Cancer
Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Healthy Volunteers:
No

• Dose level 1 participants with histologically proven advanced solid tumors, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated

• Dose level 1 participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to (<=) 1 and Karnofsky Scale greater than or equal to (>=) 70 percent (%)

• Dose level 2 and main part participants with ECOG PS <= 2 and Karnofsky Scale >= 60%

• Dose level 2 and main part participants with histologically confirmed SCLC

• Dose level 2 and main part participants with radiologically confirmed progression after first-line or chemoradiation platinum-based treatment (carboplatin or cisplatin), with or without immunotherapy, for treatment of limited or extensive stage SCLC, with a Platinum-free interval (PFI) less than (<) 90 days. The PFI is measured by the elapsed time from the last day of the regimen of a platinum-based treatment until the first day of documented disease progression

• Dose level 2 and main part participants with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (RECISTv1.1) at Screening. Evidence of measurable disease must be confirmed by the IRC prior to start of treatment

• Tumor tissue provision: archival (collected within 12 months before date of informed consent form [ICF]) signature for Screening) or fresh biopsy specimen, if medically feasible

• Have adequate hematologic and renal function

• Other protocol defined inclusion criteria could apply

Where is this trial taking place?
United States
California
Providence Medical Foundation
Recruiting
Santa Rosa
St Joseph Heritage Healthcare
Recruiting
Santa Rosa
Indiana
Memorial Hospital of South Bend
Withdrawn
South Bend
Kansas
Cotton-O'Neil Clinical Research Center, Hematology and Oncology
Recruiting
Topeka
Maryland
National Cancer Institute
Recruiting
Bethesda
Michigan
Cancer & Hematology Centers of Western Michigan
Recruiting
Grand Rapids
Missouri
MidAmerica Cancer Care
Recruiting
Kansas City
North Carolina
Southeastern Medical Oncology Center
Recruiting
Goldsboro
FirstHealth of the Carolinas, Inc.
Recruiting
Pinehurst
Ohio
Summa Health
Recruiting
Akron
Toledo Clinic
Recruiting
Toledo
Texas
Millennium Physicians Association, LLP
Recruiting
Houston
Other Locations
Belgium
Centre Hospitalier de l'Ardenne
Recruiting
Arlon
Institut Jules Bordet - Department of Institut Jules Bordet
Recruiting
Brussels
Universitair Ziekenhuis Gent
Recruiting
Gent
AZ Delta
Recruiting
Roeselare
CHU UCL Namur - Mont-Godinne
Recruiting
Yvoir
China
10 locations
Beijing Cancer Hospital
Recruiting
Beijing
Jilin Cancer Hospital
Recruiting
Changchun
West China Hospital, Sichuan University
Recruiting
Chengdu
Zhejiang University
Recruiting
Hangzhou
Jiangsu Province Hospital
Recruiting
Nanjing
Sichuan Cancer Hospital
Recruiting
Sichuan
West China Hospital, Sichuan University
Recruiting
Sichuan
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Recruiting
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
Recruiting
Xi'an
The First Affiliated Hospital of Zhejiang University school of medicine
Recruiting
Zhejiang
France
6 locations
Institut Bergonié
Recruiting
Bordeaux Cedex
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie
Recruiting
Créteil
Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie
Recruiting
Lille
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
Recruiting
Poitiers
CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie
Recruiting
Saint-herblain
CHU de Strasbourg - Nouvel Hôpital Civil - Service de Pneumologie
Recruiting
Strasbourg
Italy
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori Dino Amadori - IRST
Recruiting
Meldola
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Recruiting
Milano
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Recruiting
Pisa
Istituto Nazionale Tumori Regina Elena IRCCS
Recruiting
Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Recruiting
Rome
Japan
7 locations
National Cancer Center Hospital
Recruiting
Chuo-ku
Kansai Medical University Hospital
Recruiting
Hirakata-shi
National Cancer Center Hospital East
Recruiting
Kashiwa-shi
Cancer Institute Hospital of JFCR
Recruiting
Koto-ku
Kindai University Hospital
Recruiting
Osaka
Kurume University Hospital
Recruiting
Osaka
Osaka Medical and Pharmaceutical University Hospital
Recruiting
Takatsuki-shi
Spain
6 locations
Hospital Clinic de Barcelona
Recruiting
Barcelona
Hospital Universitari Vall d'Hebron
Recruiting
Barcelona
Hospital Universitario 12 de Octubre
Recruiting
Madrid
Hospital Universitario La Paz
Recruiting
Madrid
Hospital Universitario Virgen de la Victoria
Recruiting
Malaga
Hospital Universitario Virgen Macarena
Recruiting
Sevilla
Who do I contact about this trial?
Primary
US Medical Information
eMediUSA@emdserono.com
888-275-7376
Backup
Communication Center
service@emdgroup.com
+49 6151 72 5200
When is this trial taking place?
Start Date: March 29, 2021
Estimated Completion Date: March 13, 2024
How many participants will be in this trial?
Target number of participants: 86
What treatment is being studied in this trial?
Experimental: Berzosertib + Topotecan
In Japan, a Safety Run-in Part will be conducted. In case safety and tolerability is confirmed in the Safety Run-in part, Japanese participants will enroll in the Main Part of the Phase 2. Both in the Safety Run-in and Main Part of the Phase 2, participants will receive berzosertib and topotecan until disease progression or other criteria for study intervention discontinuation are met.

This content was sourced from clinicaltrials.gov

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Start Date:January 10, 2018
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