Active not recruitingPHASE2, PHASE3INTERVENTIONAL

LAM561 With RT and TMZ for Adults With Glioblastoma

This study, for adults aged 18-75 with newly diagnosed glioblastoma (a serious brain cancer), is evaluating a new medication called LAM561. Participants will receive either LAM561 or a placebo (dummy pill), alongside the usual treatments: radiotherapy and chemotherapy (temozolomide). After initial treatment, either LAM561 or the placebo will continue as a single medicine for six months. The main goals are to see if LAM561 helps people live longer and if it delays the cancer from growing. The study is double-blind, meaning neither patients nor their doctors will know who is getting the active drug or the placebo. An independent committee has reviewed safety data and concluded the study can continue safely.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Laminar Pharmaceuticals

Enrolment target

144

Start

01 Dec 2019

Estimated completion

30 Nov 2026

Primary Glioblastoma Glioblastoma Multiforme

What is this study about?

This research study is investigating a new treatment called LAM561 for people who have recently been diagnosed with glioblastoma. Glioblastoma is a type of brain cancer that can be very challenging to treat. Currently, the standard treatment involves surgery (if possible), followed by radiotherapy and a chemotherapy drug called temozolomide. This study aims to see if adding LAM561 to this standard care can improve outcomes for patients.

Participants in the study will be randomly assigned to one of two groups. One group will receive LAM561, while the other will receive a placebo, which looks identical to LAM561 but does not contain any active drug. Both groups will also receive the standard treatments of radiotherapy and temozolomide. After this initial phase, participants will continue to take either LAM561 or the placebo on its own for six months. This 'double-blind' approach means that neither you nor your doctors will know whether you are receiving the active drug or the placebo, which helps ensure the study results are fair and unbiased.

The main reasons for conducting this study are to find out if LAM561 can help people live longer (overall survival) and if it can delay the time before the cancer starts to grow again (progression-free survival). Researchers will carefully monitor participants to collect this information. An independent group of experts has already reviewed the study's safety data and confirmed that there are no concerns that would require stopping the study, meaning it is safe to continue as planned.

Key takeaways

Tests a new drug (LAM561) for newly diagnosed glioblastoma.
Compares LAM561 to a dummy pill alongside standard treatments.
Aims to improve survival and slow cancer growth.
Participants don't know if they receive the drug or placebo (double-blind).
Independent safety reviews confirm the study can continue safely.
Requires regular hospital visits and ongoing monitoring.

Who may be eligible?

This study is looking for adults aged between 18 and 75 who have been recently diagnosed with a specific type of brain cancer called glioblastoma. Your doctors must have confirmed this diagnosis based on a biopsy (a small tissue sample).

You would need to be well enough to understand and follow the study instructions and be able to take medication by mouth. Your physical condition, assessed by a score called the Karnofsky Performance Score, should be above 50%, indicating you are able to care for yourself with some help.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting and use effective contraception throughout the study and for a short period afterwards. Men participating will also need to use effective contraception. Details about previous surgery for your glioblastoma and certain genetic markers of your tumor will also be checked.

Quick self-check

Are you between 18 and 75 years old?
Have you been recently diagnosed with glioblastoma?
Can you swallow tablets or capsules?
Are you able to follow instructions for the study?
Are female participants using effective contraception if able to become pregnant (and male participants too)?

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

What does participation involve?

If you decide to join this study, you will be randomly assigned to receive either the study drug, LAM561, or a placebo (a dummy pill). You will take this along with your usual radiotherapy and chemotherapy (temozolomide) treatment. After this initial combined treatment, you will continue to take either LAM561 or the placebo as a single medicine for six months. You will have regular hospital visits for assessments, which will include medical exams, blood tests, and scans to monitor your health and how the treatment is working. The total combined duration of taking the study drug/placebo and your standard treatment, followed by the single-medicine phase, will involve ongoing follow-up for several years to track your progress and survival.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new experimental treatment that could be more effective than standard care for glioblastoma, particularly if LAM561 proves to be beneficial. However, there are potential risks associated with any new medication, including side effects that are not yet fully known. All standard treatments also carry known risks and side effects. You will be closely monitored for any health changes. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (22)

Institut Cancerologie de L'Ouest (ICO)
Angers, France
Centre Eugène Marquis (CEM)
Rennes, France
Gustave Roussy University Hospital
Rennes, France
Institut universitaire du cancer
Toulouse, France
Reaserch Fund of the Hadassah Medical Organization
Jerusalem, Israel
Istituto Oncologico Veneto IRCCS
Padova, Italy
Istituto Nazionale Neurologico Carlo Besta
Milan, Italy
Istituto Nazionale Tumori "Regina Elena"
Roma, Italy
University of Turin
Turin, Italy
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Clinic
Barcelona, Spain

+10 more sites — see the official record for the full list.

Common questions

What is Glioblastoma?

Glioblastoma is a serious and aggressive type of brain cancer. This study focuses on newly diagnosed cases.

What is a placebo?

A placebo is an inactive dummy pill that looks exactly like the study drug. It's used to compare the effects of the active medicine fairly.

Will I know if I'm getting LAM561 or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving until the study is over.

What are the main goals of this study?

The study aims to see if LAM561 can help people with glioblastoma live longer and if it can slow down the cancer's growth.

Is the study safe to continue?

Yes, an independent group of experts has reviewed the safety information and confirmed there are no concerns that would require stopping the study, so it is continuing as planned.