Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors
Recruiting
Phase 1
Phase 2
Interventional Study
High-grade Glioma
Solid Tumor, Unspecified, Child
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 18
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 28 (estimated)
- Sponsor
- Laminar Pharmaceuticals · Industry
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About This Trial
An open label, non-randomized study in pediatric patients with advanced high-grade gliomas and other solid tumors.
The study will be performed in two phases: a dose escalation phase in up to 18 patients following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a "safe" dose of LAM561 followed by an expanded safety cohort of up to 10 patients treated at the Maximum Tolerated …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age \<18 years
2. Diagnosis: Patients must have a histologically- or cytologically-confirmed advanced solid malignancy that is progressive, recurrent or refractory to standard-of-care treatment, or for which there is no standard therapy. Examples of tumors that lack a standar…
Contacts