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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511202-23-00 | Other Identifier | EU trial number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between tuvusertib monotherapy and combination therapy. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objectives of this study are to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse and safety in terms of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Arm 1: Tuvusertib with Niraparib | Experimental | In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib. |
|
| Part A, Arm 2: Tuvusertib with Lartesertib | Experimental | In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib. |
|
| Part B (dose optimization), dosing regimen 1 :Tuvusertib+Niraparib or Tuvusertib +Lartesertib | Experimental | In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy. |
|
| Part B (dose optimization), dosing regimen 2: Tuvusertib + Niraparib or Tuvusertib + Lartesertib | Experimental | In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy. |
|
| Part B: Tuvusertib Monotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tuvusertib (M1774) | Drug | Tuvusertib will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator | Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years | |
| Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs | Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator | Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years | |
| Part A and Part B: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator |
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Inclusion Criteria:
OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (that is PARPi is the last treatment before study entry)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Research & Development Institute, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| University of California San Francisco - UCSF Medical Center |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
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| Experimental |
In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy. |
|
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| Niraparib | Drug | Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib. |
|
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| Lartesertib (M4076) | Drug | Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib |
|
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| Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years |
| Part B: Overall Survival | OS is defined as the time from randomization to death due to any cause. | Time from date of randomization to death, approximately 3.5 years |
| San Francisco |
| California |
| 94158 |
| United States |
| Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research | Columbus | Georgia | 31904 | United States |
| University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion | Chicago | Illinois | 60637 | United States |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME | New York | New York | 10029 | United States |
| Next Oncology - Virginia | Fairfax | Virginia | 22031 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Chris O'Brien Lifehouse | Camperdown | Australia |
| St George Private Hospital | Kogarah | Australia |
| Liverpool Hospital - PARENT | Liverpool | Australia |
| Cliniques Universitaires Saint-Luc - STL | Brussels | Belgium |
| UZ Leuven | Leuven | Belgium |
| Ålborg Universitets Hospital - PARENT | Aalborg | Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Sjaellands Universitetshospital - other | Odense | Denmark |
| ICO - Site Paul Papin - service d'oncologie medicale | Angers | France |
| Centre Francois Baclesse - Service d'Oncologie Medicale | Caen | France |
| Centre Oscar Lambret - service de cancerologie gynecologique | Lille | France |
| Centre Leon Berard - Service d'Oncologie Medicale | Lyon | France |
| Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale | Paris | France |
| Hopital Tenon - service d'oncologie medicale | Paris | France |
| Hôpital Cochin - Hematologie et Oncologie Médicale | Paris | France |
| Hôpital Européen Georges Pompidou - Hématologie Oncologie | Paris | France |
| Hôpital Saint Joseph - Paris - Service d'Oncologie-Cancerologie | Paris | France |
| Centre Hospitalier Lyon Sud - service d'oncologie medicale | Pierre-Bénite | France |
| Centre de Radiotherapie Clinique Sainte Anne - 300207251 | Strasbourg | France |
| Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale | Strasbourg | France |
| Institut Gustave Roussy - Oncologie Médicale | Villejuif | France |
| Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie | Berlin | Germany |
| Universitaetsklinikum Bonn AoeR - Frauenklinik | Bonn | Germany |
| Universitaetsklinikum Carl Gustav Carus TU Dresden - Klinik u. Poliklinik f. Frauenheilkunde | Dresden | Germany |
| Kliniken Essen-Mitte - Gynaekologie und Gynaekologische Onkologie | Essen | Germany |
| Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde | Leipzig | Germany |
| Universitaetsklinikum Muenster - Parent | Münster | Germany |
| Universitätsklinikum Münster - Gynecology | Münster | Germany |
| Caritas-Krankenhaus St. Josef - Klinik fuer Chirurgie | Regensburg | Germany |
| Universitaetsklinikum Tuebingen - Parent | Tübingen | Germany |
| Rambam Medical Center | Haifa | Israel |
| The Lady Davis Carmel Medical Center | Haifa | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | Israel |
| Shaare Zedek | Jerusalem | Israel |
| Chaim Sheba Medical Center | Ramat Gan | Israel |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica | Bologna | Italy |
| IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola - SSD Oncologia Medica Zamagni | Bologna | Italy |
| Osp Cannizzaro Catania | Catania | Italy |
| Azienda Ospedaliero-Universitaria Renato Dulbecco - Centro Oncologico | Catanzaro | Italy |
| IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica | Milan | Italy |
| Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia | Milan | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology | Naples | Italy |
| IOV - Istituto Oncologico Veneto IRCCS - Radiologia Oncologica | Padova | Italy |
| Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A | Roma | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ostetricia e ginecologia | Rome | Italy |
| Catharina Ziekenhuis Eindhoven - Parent | Eindhoven | Netherlands |
| Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy - Dept of Chemotherapy | Bydgoszcz | Poland |
| Szpitale Pomorskie spó | Gdynia | Poland |
| Jagiellonskie Centrum Innowacji Sp. z o.o. - Centrum Bada | Krakow | Poland |
| Instytut MSF Sp.z.o.o | Lodz | Poland |
| Europejskie Centrum Zdrowia - Oddzial Onkologii | Otwock | Poland |
| MICS Centrum Medyczne Torun - Medicovernn | Torun | Poland |
| ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica | Badalona | Spain |
| Hospital Clinic de Barcelona - Servicio de Oncologia | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron - Oncology Dept. | Barcelona | Spain |
| ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica | Girona | Spain |
| Clinica Universidad de Navarra (MAD) - Oncology Service | Madrid | Spain |
| Hospital Universitario 12 de Octubre - Servicio de Oncologia | Madrid | Spain |
| Hospital Universitario Ramon y Cajal - Servicio de Oncologia | Madrid | Spain |
| Hospital Regional Universitario de Malaga - Oncology Dept | Málaga | Spain |
| Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann | Bellinzona | Switzerland |
| Kantonsspital Frauenfeld - 150509250 | Frauenfeld | Switzerland |
| Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie | Liestal | Switzerland |
| Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie | Sankt Gallen | Switzerland |
| Universitaetsspital Zuerich - Klinik fuer Gynaekologie | Zurich | Switzerland |
| Addenbrooke's Hospital - Dept of Oncology | Cambridge | United Kingdom |
| Beatson West of Scotland Cancer Centre - Dept of Medical Oncology | Glasgow | United Kingdom |
| Royal Surrey County Hospital - Dept of Oncology | Guildford | United Kingdom |
| St James's University Hospital - Dept of Oncology | Leeds | United Kingdom |
| Guy's Hospital - Dept of Medical Oncology | London | United Kingdom |
| Royal Marsden Hospital-London - Dept of Haematology/Oncology Research | London | United Kingdom |
| University College London Hospitals - NIHR/Wellcome Trust | London | United Kingdom |
| The Christie Hospital - Dept of Oncology | Manchester | United Kingdom |
| Mount Vernon Hospital - Dept of Oncology | Northwood | United Kingdom |
| Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey) | Sutton | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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