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RecruitingPHASE3INTERVENTIONAL

A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study

This study is designed for people with cancer who are already taking part in a specific Genentech or F. Hoffman-La Roche study. The main goal is to allow these patients to continue receiving their current trial treatment if it's still helping them and they can't access it outside the study. This includes different trial medicines like Ipatasertib, Tiragolumab, Atezolizumab, or a combination, as well as Bevacizumab, Entrectinib, Inavolisib, and Divarasib. It ensures that patients who are doing well on their current study treatment and don't have another way to get it, can carry on receiving this important care. It's like an extension to their current trial.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Enrolment target
100
Start
01 Jun 2023
Estimated completion
01 Mar 2033

What is this study about?

This study, called a "rollover study," is set up for people who are currently involved in another cancer treatment trial sponsored by Genentech or F. Hoffman-La Roche. If you're one of these patients and your current trial treatment is still helping you, but it's not yet available in your local area, this rollover study offers a way for you to keep receiving that treatment.

The idea is to make sure there isn't a break in your care. Sometimes, a trial medication might not be fully approved or widely available after a study ends. This rollover study steps in to bridge that gap, allowing you to continue benefiting from the treatment while it's still being studied or if access to it is limited. It's a way to maintain continuity in your treatment journey.

The study involves several different medicines, including Ipatasertib, Tiragolumab, Atezolizumab (sometimes together), Bevacizumab, Entrectinib, Inavolisib, and Divarasib. Your doctor will assess regularly whether the treatment is still suitable and effective for you. The overarching goal is to support patients who are doing well on their current study medication and ensure they can continue their treatment without disruption.

Key takeaways

  • This study is for current cancer trial participants.
  • It allows continued access to a specific trial treatment.
  • You must be benefiting from the current treatment.
  • The treatment is not yet widely available in your area.
  • Your doctor will assess if you are suitable to continue.
  • You cannot be on any other cancer trials at the same time.

Who may be eligible?

This study is for patients who are already in a specific cancer treatment study run by Genentech or F. Hoffman-La Roche. You can join if your current trial treatment is still helping you and your doctor thinks it's suitable to continue. You would typically move into this new study very soon after your original study treatment ends, usually within seven days.

However, you can't join if the treatment you're receiving is already easily available in your country for your type of cancer. Also, if your original study told you to stop the treatment for any reason, or if you've had a serious side effect that hasn't gotten better, you won't be able to join this extension study. You also can't be taking part in another cancer study at the same time, apart from the one you're rolling over from.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Am I currently in a Genentech or Roche cancer study?
  2. Is my current study treatment still working for me?
  3. Is this specific treatment not available at my local pharmacy or clinic?
  4. Have I had any serious side effects that haven't gotten better?
  5. Am I involved in any other cancer research studies right now?
Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the same study medication (or combination of medications) that you were getting in your previous Genentech or F. Hoffman-La Roche cancer study. The visits and assessments will likely be similar to what you've experienced before, allowing your doctors to carefully monitor your health and how the treatment is working. This is an ongoing treatment study, so the duration will depend on how well you are responding to the treatment and if your doctor believes it is still the best option for you. You won't be expected to take any additional cancer treatments while in this study, other than what's specifically allowed by the study rules.

Potential risks and benefits

The main potential benefit of joining this study is the chance to continue receiving a treatment that has been effective for you during your previous clinical trial, especially if it's not yet available outside of a study. However, all medical treatments carry potential risks, including side effects from the medications. Your medical team will monitor you closely for any new or ongoing side effects. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (58)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • GHdC Site Les Viviers
    Verified postcode
    Charleroi, Belgium· Completed
  • AZ Groeninge
    Verified postcode
    Kortrijk, Belgium· Active not recruiting
  • UZ Leuven Gasthuisberg
    Verified postcode
    Leuven, Belgium· Completed
  • Princess Margaret Cancer Center
    Verified postcode
    Toronto, Canada· Recruiting
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
    Verified postcode
    XI 'an City, Shaanxi Province, China· Recruiting
  • Beijing Cancer Hospital
    Verified postcode
    Beijing, China· Recruiting
  • the First Hospital of Jilin University
    Verified postcode
    Changchun, China· Recruiting
  • West China Hospital of Sichuan University
    Verified postcode
    Chengdu, China· Recruiting
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
    Verified postcode
    Hangzhou, China· Recruiting
  • Harbin Medical University Cancer Hospital
    Verified postcode
    Harbin, China· Recruiting
  • The Second Affiliated Hospital of Anhui Medical University
    Verified postcode
    Hefei, China· Recruiting
  • Meizhou People's Hospital
    Verified postcode
    Meizhou, China· Recruiting

Common questions

What is a 'rollover study'?

It's an extension study that allows people already in a specific cancer trial to continue receiving their treatment if it's still helping them and they can't get it elsewhere.

Which cancer treatments are involved?

The study offers ongoing access to several medicines like Ipatasertib, Tiragolumab, Atezolizumab (alone or combined), Bevacizumab, Entrectinib, Inavolisib, and Divarasib.

Do I have to pay for the treatment?

No, if you're eligible for this clinical trial, the study treatment is provided at no cost to you.

How long will I be on the study treatment?

You will continue as long as the treatment is benefiting you, and your doctor determines it's still the best course of action.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your usual medical care.

How to find out more

Reference Study ID Number: BX44273 https://forpatients.roche.com/

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Rollover Study for Participants Previously Enrolled in a G…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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