RecruitingPHASE3INTERVENTIONAL

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

This ongoing research study allows patients with advanced or metastatic cancer, who are already doing well on a specific treatment in earlier trials, to continue receiving that medication. The main goal is to keep an eye on the treatment's long-term safety and observe its effects over a longer period. It's designed for patients whose previous company-sponsored study has finished, but they are still showing benefit from the treatment. This helps ensure that patients who are responding positively to the drug can keep accessing it while researchers gather more information about its long-term use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Daiichi Sankyo

Enrolment target

Start

05 Jan 2024

Estimated completion

17 Jan 2028

Advanced Cancer Metastatic Cancer

What is this study about?

This study is designed for people who have advanced cancer, meaning it has spread or is difficult to treat, and who are already taking part in another clinical trial sponsored by Daiichi Sankyo or with AstraZeneca. If you've been receiving a particular cancer medicine in one of these previous trials and it’s been helping you, this study allows you to continue getting that treatment.

The main purpose of this study is to look at the long-term safety of the medication you're already taking. It helps doctors understand if there are any side effects that appear over a longer period, and how well the treatment continues to work over time. It’s like a 'rollover' – when your current study finishes, if you're still benefiting, you can roll over into this new study to keep receiving the medication.

This study will include different types of cancer treatments, but all parts of the study will follow the same basic rules and procedures. This way, researchers can gather important long-term information about these vital cancer medications while ensuring patients who are doing well can continue their treatment.

Key takeaways

This study is for advanced or metastatic cancer patients who are currently benefiting from a specific treatment.
It allows you to continue receiving that treatment from your previous clinical trial.
The main aim is to gather long-term information on the treatment's safety and effectiveness.
You must be 18 or older and have shown benefit from the treatment without your cancer getting worse.
Regular check-ups will monitor your health and response to the treatment.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, you must already be taking part in a specific cancer treatment study sponsored by Daiichi Sankyo or Daiichi Sankyo/AstraZeneca, and that study must be coming to an end. It's important that your doctors believe you are still benefiting from the treatment you've been receiving, and there's no sign your cancer is getting worse.

You also need to agree to take part and understand all the requirements of the study before you start. You must be at least 18 years old; there's no upper age limit.

You won't be able to join if you've had significant side effects from the treatment that haven't cleared up or if you've already stopped taking the study treatment for more than 18 weeks (about 4 and a half months) since your last dose in the previous study.

Quick self-check

Are you currently receiving a cancer treatment in a Daiichi Sankyo or Daiichi Sankyo/AstraZeneca clinical trial?
Has your current trial finished or is it coming to an end?
Do you and your doctor believe you are still benefiting from the treatment?
Is your cancer currently stable and not getting worse?
Are you at least 18 years old?
Have you not stopped your current treatment for more than 18 weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will continue to receive the same cancer treatment you were getting in your previous study. You'll have regular visits with the study team, who will check your health and how you're responding to the treatment. These visits will involve physical exams, blood tests, and other assessments, similar to what you might have had in your earlier trial. The study team will monitor you closely for any side effects and to see if the treatment is still helping your cancer. The total duration of your participation will depend on how you respond to the treatment and your health, but it's designed for long-term follow-up.

Potential risks and benefits

The potential benefits of joining this study include continuing to receive a cancer treatment that has already shown to be helpful for you, potentially slowing your cancer's progression or improving your quality of life. However, all medical treatments carry potential risks, including side effects from the medication, some of which may be serious. The study team will carefully monitor you for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (28)

Miami Cancer Institute
Miami, United States· Recruiting
Duke University - Trent Center
Durham, United States· Recruiting
Flinders Medical Center
Bedford Park, Australia· Active not recruiting
Monash Medical Center
Melbourne, Australia· Withdrawn
Grand Hôpital de Charleroi
Charleroi, Belgium· Recruiting
Instituto Aericas
Rio de Janeiro, Brazil· Not yet recruiting
A.C. Camargo Cancer Center
São Paulo, Brazil· Not yet recruiting
IBCC Nucleo de Pequisa e Ensino
São Paulo, Brazil· Not yet recruiting
Institut Gustave Roussy
Villejuif, France· Recruiting
Rabin Medical Center
Petah Tikva, Israel· Active not recruiting
Ospedale San Raffaele
Milan, Italy· Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy· Withdrawn

+16 more sites — see the official record for the full list.

Common questions

What kind of cancer is this study for?

This study is for people with advanced or metastatic cancer, meaning cancer that has spread or is difficult to treat.

Do I have to be in another study to join this one?

Yes, you must already be getting this treatment in a previous company-sponsored study that is finishing, and it must be helping you.

What does 'long-term safety' mean?

It means the study will watch how safe the treatment is over many months or years, looking for any side effects that might appear over time.

Will I get a new medicine in this study?

No, you will continue to receive the same medicine that you were taking in your previous study.

Can I stop being part of the study whenever I want?

Yes, you have the right to leave the study at any time, and it won't affect your future medical care.

How to find out more

Daiichi Sankyo Contact for Clinical Trial Information

CTRinfo@dsi.com 908-992-6400 Official trial record

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