Lung Cancer Clinical Trial

Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Clinically relevant (that is [i.e.], active), uncontrolled intercurrent illness including, but not limited to, severe active infection including, severe acute respiratory syndrome coronavirus-2 infection/coronavirus disease 2019, immune deficiencies, uncontrolled diabetes, uncontrolled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification greater than or equal to [>=] Class III), unstable angina pectoris, myocardial infarction, uncontrolled cardiac arrhythmia, cerebral vascular accident/stroke. Calculated corrected QT interval (QTc) average (using the Fridericia correction calculation) of greater than [>] 450 millisecond (msec) for males and > 470 msec for females. Any psychiatric illness/social situations that would limit compliance with study requirements
Unstable brain metastases; however, participants with known brain metastases may be enrolled in this clinical study if they are clinically stable (without evidence of progression by imaging for at least 2 weeks prior to the first study intervention dose and any neurologic symptoms have returned to baseline), have no evidence of new brain metastases, and are on a stable or decreasing dose of steroids for at least 14 days prior to study intervention Participants with carcinomatous meningitis are excluded regardless of clinical stability. Screening central nervous system imaging is not mandatory
Prior malignant disease within the last 3 years. Exceptions include fully resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ cervical cancer, fully resected ductal carcinoma in situ of the breast, superficial or noninvasive bladder cancer, and Stage IA, Grade I endometrioid endometrial cancer with no myometrial invasion, that has undergone curative therapy. Participants with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor
Participants not recovered from adverse events (AEs) Grade > 1 from prior anticancer therapies, including surgeries. Exception: Grade 2 AEs not constituting a safety risk (for example [e.g.], alopecia), based on the Investigator's judgment; must consult with the medical Monitor prior to enrollment.
Other protocol defined exclusion criteria could apply

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

76

Study ID:

NCT04768296

Recruitment Status:

Completed

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 13 Locations for this study

See Locations Near You

Providence Medical Foundation
Santa Rosa California, 95403, United States
St Joseph Heritage Healthcare
Santa Rosa California, 95403, United States
Cotton-O'Neil Clinical Research Center, Hematology and Oncology
Topeka Kansas, 66606, United States
National Cancer Institute
Bethesda Maryland, 20892, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids Michigan, 49546, United States
MidAmerica Cancer Care
Kansas City Missouri, 64114, United States
NJ Center for Cancer Research
Brick New Jersey, 08724, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
FirstHealth of the Carolinas, Inc.
Pinehurst North Carolina, 28374, United States
Summa Health
Akron Ohio, 44304, United States
Toledo Clinic
Toledo Ohio, 43623, United States
Millennium Physicians Association, LLP
Houston Texas, 77090, United States
Centre Hospitalier de l'Ardenne
Arlon , , Belgium
Institut Jules Bordet - Department of Institut Jules Bordet
Brussels , , Belgium
Universitair Ziekenhuis Gent
Gent , , Belgium
AZ Delta
Roeselare , , Belgium
CHU UCL Namur - Mont-Godinne
Yvoir , , Belgium
Beijing Cancer Hospital
Beijing , , China
Jilin Cancer Hospital
Changchun , , China
Sichuan Cancer Hospital
Chengdu , , China
West China Hospital, Sichuan University
Chengdu , , China
Jiangsu Province Hospital
Nanjing , , China
Liaoning Cancer Hospital & Institute
Shenyang , , China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan , , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an , , China
The First Affiliated Hospital of Zhejiang University school of medicine
Zhejiang , , China
Institut Bergonié
Bordeaux cedex , , France
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie
Créteil , , France
Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie
Lille , , France
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
Poitiers , , France
CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie
Saint-Herblain , , France
CHU de Strasbourg - Nouvel Hôpital Civil - Service de Pneumologie
Strasbourg , , France
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST
Meldola , , Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milano , , Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Pisa , 56124, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Roma , 00144, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Rome , , Italy
National Cancer Center Hospital
Chuo-ku , , Japan
Kansai Medical University Hospital
Hirakata-shi , , Japan
National Cancer Center Hospital East
Kashiwa-shi , , Japan
Cancer Institute Hospital of JFCR
Koto-ku , , Japan
Kindai University Hospital
Osaka , , Japan
Kurume University Hospital
Osaka , , Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi , , Japan
Hospital Clinic de Barcelona
Barcelona , , Spain
Hospital Universitari Vall d'Hebron
Barcelona , , Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Universitario La Paz
Madrid , , Spain
Hospital Clinico Universitario Virgen de la Victoria - Oncology Service
Malaga , , Spain
Hospital Universitario Virgen de la Victoria
Malaga , , Spain
Hospital Universitario Virgen Macarena
Sevilla , , Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

76

Study ID:

NCT04768296

Recruitment Status:

Completed

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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