Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

This research study is testing a new drug called ASTX660 for people who have advanced solid tumours or lymphomas where standard treatments haven't been successful. The study has two main parts. The first part, which has been completed, aimed to find the safest and most effective dose of ASTX660. The second part of the study is now looking at how well this drug works in different types of cancer. We want to see if it can help slow down or shrink tumours. Participants in the study will continue to receive the treatment until their cancer gets worse, they experience serious side effects, or they decide they no longer want to participate.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Taiho Oncology, Inc.

Enrolment target

253

Start

14 Jul 2015

Estimated completion

01 Dec 2027

Solid Tumors Lymphoma

What is this study about?

This study is investigating a new medication called ASTX660. It's designed for people who have advanced cancers, specifically solid tumours or lymphomas, when their usual treatments are no longer effective at controlling the disease. Imagine your body has natural ways to deal with old or damaged cells; sometimes, cancer cells can switch off these natural processes. ASTX660 is a type of drug that aims to switch these processes back on, potentially helping the body to get rid of cancer cells.

The study has been divided into two main stages. The first stage, which has already finished, was all about figuring out the safest amount of ASTX660 to give and how often. This is a crucial step for any new drug to make sure it's as safe as possible for patients. Now, in the second stage, researchers are looking more closely at how well ASTX660 works against specific types of cancer. They want to see if it can help to shrink tumours or stop them from growing.

Taking part in this study means you would receive ASTX660 and be closely monitored by a medical team. The goal is to gather more information about this potential new treatment. This kind of research is vital for developing new ways to fight cancer, especially for those whose options are limited.

Key takeaways

Tests a new drug (ASTX660) for advanced cancers.
Aimed at solid tumours and lymphomas when standard treatments aren't helping.
Checks drug safety and how well it shrinks tumours.
Involves regular medical check-ups and monitoring.
You can withdraw from the study at any time.
Access to a potential new treatment.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, and be able to understand what’s involved and agree to take part. You must have a confirmed diagnosis of an advanced solid tumour or lymphoma that has spread or can’t be removed by surgery, and where current standard long-term treatments are no longer an option for you.

If you're considering the second part of the study (Phase 2), especially for certain types of lymphoma (like PTCL – Peripheral T-cell Lymphoma), your doctor will need to check some specific recent reports about your cancer. Also, you would generally need to have tried at least two other types of treatments for your cancer previously, and your cancer should have shown signs of getting worse after those treatments. You also need to have cancer that can be measured or seen on scans.

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.

Are you 18 years old or older?
Do you have an advanced solid tumour or lymphoma?
Have your standard cancer treatments stopped working?
Are you able to attend regular hospital appointments and tests?
Have you understood what taking part in a study involves and given your written consent?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the study drug ASTX660. The exact details of how often you take it and how it's given will be explained by the medical team based on what they learned in the first part of the study. You will have regular appointments and tests, such as blood tests and scans, to check your health, how the drug is affecting you, and if your cancer is responding. These visits will help the doctors understand the drug's safety and effectiveness. You'll continue to receive the treatment for as long as it's helping and you're not experiencing difficult side effects, or until your medical team decides it's no longer the best option for you. The overall duration you'd be in the study can vary greatly depending on how your body responds to the treatment.

Potential risks and benefits

Participating in a clinical trial like this could potentially offer you access to a new treatment (ASTX660) before it's widely available. While we hope the drug will help, there's no guarantee it will work for everyone, and it might not improve your condition. There's also a chance you could experience side effects from the drug, some of which might be unpleasant, and your medical team will discuss these with you in detail. You are always in control and have the absolute right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (68)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
HonorHealth Research Institute
Verified postcode
Scottsdale, United States
USC/Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States
UC Davis Medical Center
Verified postcode
Sacramento, United States
Simlow Cancer Hospital at Yale
Verified postcode
New Haven, United States
Emory University winship Cancer Institute
Verified postcode
Atlanta, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Verified postcode
Chicago, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Verified postcode
Baltimore, United States
Tufts Medical Center
Verified postcode
Boston, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States
University of Michigan
Verified postcode
Ann Arbor, United States

Common questions

What is ASTX660?

ASTX660 is an experimental drug designed to help the body fight cancer cells in advanced solid tumours and lymphomas.

Who is this study for?

It's for adults (18+) with advanced solid tumours or lymphomas when standard treatments haven't worked or are not available.

What happens if I join?

You'll receive the study drug, have regular medical check-ups, blood tests, and scans to monitor your health and the treatment's effects.

Can I stop participating in the study?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Will this drug cure my cancer?

While we hope ASTX660 will be beneficial, there's no guarantee it will cure your cancer, as it's still being investigated.