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Be Part of Research - Trial Details - LAM561 With RT and TMZ for Adults With Glioblastoma
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LAM561 With RT and TMZ for Adults With Glioblastoma

Not Recruiting

Open to: ALL

Age: 18.0 - 75.0

London Newcastle Birmingham Cambridge

Medical Conditions

Glioblastoma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of LAM561 versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then LAM561 or placebo in monotherapy.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2019 Oct 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Subjects in Arm B will receive orally LAM561 during the Chemoradiation Phase.

Subjects in Arm B will receive LAM561 orally during the Maintenance (Adjuvant) Phase. Patients will continue to be administered with LAM561/Placebo after cycle 6 of the monotherapy phase until end of study. Adjuvant treatment will be discontinued upon determination of tumour progression as defined by RANO criteria, unacceptable toxicity, or refusal to continue study treatment.

Intervention Arm Group : Arm B: SoC + 12 g/day of LAM561;

Intervention Type : DRUG
Intervention Description : TMZ will be administered at 75 mg/m2, orally, once daily, continuously from Day 1 of radiotherapy to the last day of radiation for a maximum of 49 days.

During the Maintenance (Adjuvant) Phase, all subjects will receive oral TMZ 150 - 200 mg/m2 once daily on Days 1 - 5 of each 28-day cycle for 6 cycles.

Intervention Arm Group : Arm A: SoC + placebo for LAM561;Arm B: SoC + 12 g/day of LAM561;

Intervention Type : RADIATION
Intervention Description : During the Chemoradiation Phase, all subjects will undergo focal RT, with one treatment given daily 5 days per week over approximately 6 weeks (and no more than 7 weeks).

Intervention Arm Group : Arm A: SoC + placebo for LAM561;Arm B: SoC + 12 g/day of LAM561;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden Hospital
    London
  • Freeman Hospital's Northern Centre of Cancer Care
    Newcastle
    Newcastle Upon Tyne
    NE7 7DN
  • University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital
    Birmingham
  • Cambridge University Hospital
    Cambridge


The study is sponsored by Laminar Pharmaceuticals and is in collaboration with Laboratory Corporation of America; Northern Institute for Cancer Research, Newcastle; Theradis pharma; LIPODOM THERAPEUTICS.



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Read full details for Trial ID: NCT04250922
Last updated 29 May 2024

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