LAM561 With RT and TMZ for Adults With Glioblastoma (NCT04250922) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
LAM561 With RT and TMZ for Adults With Glioblastoma
France, Israel144 participantsStarted 2019-12-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Written informed consent, signed and dated
✓. Subjects who are able to understand and follow instructions during the trial
✓. Age ≥18 and ≤75
✓. Subjects with newly histologically confirmed intracranial malignant glioma (glioblastoma WHO Grade IV) that is IDH1 wildtype (local assessment) and who are scheduled to receive chemo-radiotherapy with temozolomide
✓. Ability to swallow and retain oral medication
✓. Centrally obtained MGMT promoter methylation status
✓. Subjects who underwent total or partial / incomplete resection and with the appropriate quantity of tumour tissue releasable for eligibility
✓. Karnofsky Performance Score (KPS) \> 50 %
Exclusion criteria
✕. Known hypersensitivity to any component of the investigational product.
✕. Any other investigational drug within the preceding 30 days. Prior, concomitant, or planned concomitant treatment with anti-neoplastic aim including (but not limited) to NovoTumor Treatment Fields (Novo TTF), bevacizumab, intratumoural or intracavitary anti-neoplastic therapy (e.g Gliadel wafers), or other experimental therapeutics intended to treat the tumour.
✕. Subjects who underwent "only biopsy" resection
✕
What they're measuring
1
To evaluate the efficacy of LAM561 in combination with the standard of care (SoC) treatment of radiotherapy (RT) and TMZ.
Timeframe: Assessed after observing at least 66 PFS events
2
To evaluate the efficacy of LAM561 in combination with the standard of care (SoC) treatment of radiotherapy (RT) and TMZ.
Timeframe: Assessed after observing at least 90 OS events
. Anticancer therapy within 4 weeks of study entry (6 weeks for mitomycin and nitrosoureas)
✕. Other major surgery within the preceding 30 days
✕. Allergy, hypersensitivity or other intolerability to temozolomide and its excipients, patients with hypersensitivity to dacarbazine and patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
✕. Unable to undergo MRI
✕. Presenting with diffuse midline gliomas or multifocal GBM (distant from the flare or contralateral) or rapid progression between early post-surgery MRI and pre-radiotherapy MRI