Continued Cancer Treatment Study with Abiraterone, Ipatasertib, Tiragolumab, and Drug Combination for Patients from Previous Genentech/Roche Trials

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What is this study about?

This clinical trial is focused on providing continued treatment for patients with cancer who were previously part of a study sponsored by Genentech or F. Hoffmann-La Roche Ltd. The study aims to offer ongoing access to specific treatments that patients may not have available locally. The treatments being studied include several medications: Abiraterone, Ipatasertib, Tiragolumab, and Tecentriq. These medications are used in various forms, such as tablets or infusions, to help manage cancer.

The purpose of this study is to ensure that patients who are benefiting from these treatments can continue to receive them. The study will follow patients who are still on their treatment regimen from a previous study and do not have access to these medications outside of the trial. The study will monitor the number of participants who continue to have access to these treatments and will also observe any side effects that may occur.

Participants in this study will receive their treatment over a period of up to 120 days. The medications will be administered either orally or through an infusion, depending on the specific treatment. This study is designed to help maintain the health and well-being of patients who have already shown positive responses to these treatments in earlier studies.

1 joining the study

Upon joining the study, you will continue the treatment you were receiving in the previous study. This is an extension study designed to provide continued treatment for eligible patients with cancer who were previously enrolled and treated in a Genentech/Roche study.

The first dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study.

2 treatment administration

You will receive continued treatment with Roche investigational medicinal product (IMP)-based therapy and/or comparator agent(s).

The medications involved in this study include abiraterone (oral film-coated tablet), ipatasertib (oral film-coated tablet), tiragolumab (solution for infusion), and atezolizumab (intravenous or subcutaneous).

The specific dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare provider.

3 monitoring and assessments

Throughout the study, your health will be closely monitored. This includes regular assessments to evaluate the benefits of the treatment and to check for any side effects.

The incidence, nature, and severity of any adverse events will be recorded and assessed.

4 end of study participation

The study is estimated to end by March 1, 2033. Your participation may continue until this date or until you no longer benefit from the treatment, as assessed by your healthcare provider.

Your participation will also end if you experience unacceptable side effects or if your condition worsens.

Who Can Join the Study?

The patient must be eligible to continue with the Roche investigational medicinal product (IMP)-based therapy or the comparator agent from the previous study, according to the rules of that study.
The first dose of the study treatment in this extension study must be received within 7 days of the allowed break from the previous study’s treatment.
The patient must still be benefiting from the Roche IMP-based therapy or comparator at the time of joining this study, as determined by the study doctor. This means the patient should not have any unacceptable side effects or worsening symptoms due to the disease, based on a review of medical images, biopsy results (if available), and overall health.
Women who can have children must have a negative urine pregnancy test within 24 hours before receiving the first dose of the study treatment.
The patient must be able to follow the rules and requirements of the extension study, as judged by the study doctor.

Who Cannot Join the Study?

Patients who have not previously participated in a Genentech/Roche study related to this treatment.
Patients who have access to the study treatment locally and do not need to continue in this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Grand Hopital De Charleroi	Charleroi	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Centre Hospitalier Saint Joseph Saint Luc	Lyon	France
Pratia S.A.	Skorzewo	Poland
Institut De Cancerologie De Bourgogne	Dijon	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Iofpgsre Rguxikha De Clcvjv Dh Mncywuetzle	Montpellier	France
Adwfgpvfjs Pnppwnru Hqoiosvq Dw Msvjnrisi	Marseille	France
Nwjwpxxy Izficaxv Orkhqthcd Itl Mngmo Stzrenjekrdykkfzoubfuaviqqlz Iqyieoqs Bqnnllof	Cracow	Poland
Uzudvbkyvciksx Cjsjdmu Kgbrzhozg	Gdansk	Poland
Idgjlhwz Cprxj	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	28.04.2023
France	Recruiting	28.04.2023
Greece	Recruiting	28.04.2023
Poland	Recruiting	28.04.2023

Trial locations

Investigated drugs:

Roche investigational medicinal product (IMP) is a type of treatment that is still being studied and is not yet available to the public. It is designed to help treat cancer by targeting specific parts of cancer cells or the environment around them. This medication is part of a research study to see how well it works and how safe it is for patients who have already been receiving it in a previous study. The goal is to continue providing this treatment to patients who are benefiting from it and do not have other ways to get it.

Investigated diseases:

Neoplasm

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. It can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. The progression of cancer involves stages, starting from a localized tumor that can invade nearby tissues. As it advances, cancer cells may spread to other parts of the body through the blood and lymph systems, a process known as metastasis. The rate of progression and the specific symptoms depend on the type and location of the cancer. Over time, cancer can affect the normal functioning of the body systems where it has spread.

Trial ID:

2023-504263-16-00

Protocol code:

BX44273

Trial Phase:

Therapeutic confirmatory (Phase III)

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Continued Cancer Treatment Study with Abiraterone, Ipatasertib, Tiragolumab, and Drug Combination for Patients from Previous Genentech/Roche Trials

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?