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RMC-5552 for Glioblastoma
Study Summary
This trial is testing a new drug, RMC-5552, to see if it can help treat glioblastoma, a type of brain cancer. The new drug works by preventing the formation of a protein called mTOR, which is involved in cancer cell growth.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Group 1: Cohort A2 (Dose Escalation, Recurrent Non-surgical GBM)
- Group 2: Cohort A 1(Dose Escalation, Recurrent Non-surgical GBM)
- Group 3: Cohort B (Dose Expansion, Recurrent Surgical GBM)
- Group 4: Cohort C (Dose Expansion, Recurrent Non-surgical GBM)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What outcomes is the research team hoping to achieve?
"This 3-year clinical trial's primary objective is to assess the median concentration of RMC-5552 in plasma for Cohort B. Secondary endpoints consist of Area under the Plasma Concentration Time Curve (AUC) for participants in both Cohorts A and C, Median Duration of Response for Cohort A, and Proportion of Participants with detectable levels of pAKT in Tumor Tissue from Cohort B. All pharmacokinetic parameters will be determined through non-compartmental analysis methods while all pharmacodynamic markers shall relate to mTORC1 pathway inhibition assessment within fresh tumour tissue specimens as well as archived"
Are there any opportunities for prospective participants to join this experiment?
"According to clinicaltrials.gov, this specific medical trial is no longer recruiting participants; however, there are currently 1391 other studies that still require patients. This experiment was first posted on November 1st 2022 and the most recent update occurred at the end of September in the same year."
Has the Cohort A (Dose Escalation, Recurrent Non-surgical GBM) protocol been accorded clearance by the FDA?
"Our team at Power assigned Cohort A (Dose Escalation, Recurrent Non-surgical GBM) a safety score of 1 due to the limited evidence that exists in Phase 1 trials regarding treatment efficacy and patient safety."
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