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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003414-36 | EudraCT Number | ||
| 2023-504263-16-00 | EU Trial (CTIS) Number |
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The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roche IMP(s) Monotherapy | Experimental | Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. |
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| Roche Combined Agents | Experimental | Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipatasertib | Drug | Ipatasertib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s) | Up to approximately 10 years | |
| Number and Severity of Participants With Selected Adverse Events Assessed as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Up to approximately 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BX44273 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHdC Site Les Viviers | Completed | Charleroi | 6060 | Belgium | ||
| AZ Groeninge |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Tiragolumab | Drug | Tiragolumab in combination with atezolizumab will be administered at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study. |
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| Atezolizumab | Drug | Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study. |
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| Tiragolumab and Atezolizumab | Drug | Tiragolumab and Atezolizumab in fixed dose combination administered intravenously (IV) at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study. |
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| Bevacizumab | Drug | Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study. |
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| Entrectinib | Drug | Entrectinib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study. |
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| Inavolisib | Drug | Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study. |
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| Divarasib | Drug | Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study. |
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| Active, not recruiting |
| Kortrijk |
| 8500 |
| Belgium |
| UZ Leuven Gasthuisberg | Completed | Leuven | 3000 | Belgium |
| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G 1Z5 | Canada |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Recruiting | XI 'an City, Shaanxi Province | Shaanxi | 710061 | China |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| Beijing Cancer Hospital | Recruiting | Beijing | 100142 | China |
| the First Hospital of Jilin University | Recruiting | Changchun | 130021 | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | 610041 | China |
| Cancer Center of Guangzhou Medical University | Recruiting | Guangzhou | 510000 | China |
| Sir Run Run Shaw Hospital Zhejiang University | Recruiting | Hangzhou | 310016 | China |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | 150081 | China |
| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | 230601 | China |
| Meizhou People's Hospital | Recruiting | Meizhou | 514031 | China |
| The 1st Affiliated Hospital of Nanchang Unversity | Recruiting | Nanchang | 330052 | China |
| Jiangsu Province Hospital of Chinese Medicine | Recruiting | Nanjing | 210029 | China |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | 200120 | China |
| Shanghai Geriatric Medical Center | Recruiting | Shanghai | 201104 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | 430023 | China |
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | 361003 | China |
| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | China |
| Henan Cancer Hospital | Recruiting | Zhengzhou | 450008 | China |
| Clinica CIMCA | Active, not recruiting | San José | 10103 | Costa Rica |
| ICIMED Instituto de Investigación en Ciencias Médicas | Active, not recruiting | San José | 10108 | Costa Rica |
| Institut Bergonie | Recruiting | Bordeaux | 33076 | France |
| Centre Francois Baclesse | Recruiting | Caen | 14076 | France |
| Institut de Cancérologie de Bourgogne | Recruiting | Dijon | 21000 | France |
| Centre Leon Berard | Recruiting | Lyon | 69373 | France |
| Hopital de la Timone | Recruiting | Marseille | 13005 | France |
| Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque | Recruiting | Montpellier | 34298 | France |
| Institut de cancerologie du Gard | Completed | Nîmes | 30029 | France |
| Institut Curie | Recruiting | Paris | 75005 | France |
| Hopital Tenon | Recruiting | Paris | 75970 | France |
| ICO - Site René Gauducheau | Recruiting | Saint-Herblain | 44805 | France |
| Institut Claudius Regaud | Recruiting | Toulouse | 31059 | France |
| Gustave Roussy | Recruiting | Villejuif | 94800 | France |
| General Hospital "G.Papanikolaou" | Recruiting | Asvestochóri | 570 10 | Greece |
| Metropolitan General Hospital | Recruiting | Cholargós | 155 62 | Greece |
| National Cancer Center Hospital East | Recruiting | Chiba | 277-8577 | Japan |
| Kyushu University Hospital | Recruiting | Fukuoka | 812-8582 | Japan |
| Toranomon Branch Hospital | Recruiting | Kanagawa | 213-8587 | Japan |
| Yokohama City University Medical Center | Active, not recruiting | Kanagawa | 232-0024 | Japan |
| Kanagawa Cancer Center | Completed | Kanagawa | 241-8515 | Japan |
| National Cancer Center Hospital East | Recruiting | Kashiwa-shi | 277-8577 | Japan |
| Saitama Cancer Center | Recruiting | Saitama | 362-0806 | Japan |
| NHO Kinki-Chuo Chest Medical Center | Recruiting | Sakaishi | 591-8555 | Japan |
| Centro Medico Culiacan SA de CV | Active, not recruiting | Culiacán | Sinaloa | Mexico |
| Medical Care & Research | Completed | Mérida | Yucatán | 97070 | Mexico |
| Consultorio de Especialidad en Urologia Privado | Active, not recruiting | Durango | 34000 | Mexico |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gda?sk | 80-214 | Poland |
| Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie | Recruiting | Warsaw | 02-781 | Poland |
| Moscow City Oncology Hospital #62 | Recruiting | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Russian Scientific Center of Roentgenoradiology | Active, not recruiting | Moscow | Moscow Oblast | 117997 | Russia |
| P.A. Herzen Oncological Inst. | Recruiting | Moscow | Moscow Oblast | 125248 | Russia |
| Seoul National University Bundang Hospital | Completed | Seongnam-si | 463-707 | South Korea |
| Asan Medical Center | Active, not recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Taichung Veterans General Hospital | Recruiting | Taichung | 407 | Taiwan |
| National Cheng Kung University Hospital | Recruiting | Tainan | 70457 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 110 | Taiwan |
| Chang Gung Memorial Hospital - Linkou | Active, not recruiting | Taoyuan | 333 | Taiwan |
| Chulalongkorn Hospital | Active, not recruiting | Bangkok | 10330 | Thailand |
| Siriraj Hospital | Recruiting | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiangmai Hospital | Active, not recruiting | Chiang Mai | 50200 | Thailand |
| Leicester Royal Infirmary | Recruiting | Leicester | LE1 5WW | United Kingdom |
| Royal Marsden Hospital - Surrey | Completed | Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C583616 | ipatasertib |
| C000730814 | Tiragolumab |
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| C000607349 | entrectinib |
| C000723546 | inavolisib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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