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Pre- and Post-Surgery Sapanisertib for Brain Cancer
Study Summary
This trial looks at a new drug to treat brain tumors. The drug, sapanisertib, may stop the growth of tumor cells by blocking enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
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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- My brain tumor is growing or has returned, and I can have MRIs.I haven't had any major health events in the last 6 months.I have been treated for relapses no more than twice.I am not currently taking proton pump inhibitors.I have recovered from serious side effects of my previous cancer treatment.I have no allergies to MLN0128 (TAK-228) or similar drugs.I have not been treated with mTOR, PI3 kinase, or Akt inhibitors.I do not have serious heart or lung disease currently.I am not HIV-positive or on antiretroviral therapy.My brain tumor has returned or worsened after treatment.I am not taking any medication for epilepsy that increases enzyme activity.I have not started bisphosphonates within the last 30 days.I do not have any conditions that affect my body's ability to absorb nutrients.My doctor has recommended surgery for my condition.I have no other cancers except possibly treated skin cancer.I am cautious about my medication affecting the trial treatment.My diabetes is well-controlled.I can care for myself but may need occasional help.I am eligible for surgery based on my doctor's assessment.I do not have any uncontrolled illnesses.I can swallow pills without any issues.My blood, kidney, and liver functions are normal.
- Group 1: Arm I (sapanisertib before and after surgery)
- Group 2: Arm II (sapanisertib after surgery)
- 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
How many participants is this clinical trial accommodating?
"Unfortunately, this study is no longer open for enrolment. It was initially posted on May 12th 2014 and the last update to its listing happened August 11th 2022. For those still interested in medical trials, there are presently 443 glioblastoma studies recruiting patients as well as 11 Sapanisertib effort actively enrolling participants."
What is the regulatory standing of Sapanisertib?
"Due to the early stage of this trial, our Power team assigned a score of 1 for Sapanisertib's safety. This is because there exists only minimal data that has been collected on efficacy and security."
How many sites are administering the study?
"This clinical trial is actively recruiting from 10 sites in various cities, including Birmingham, Cleveland and Baltimore. To reduce travel constraints, it's advisable to select the closest medical centre when enrolling as a participant."
Are there any further investigations that have been done concerning Sapanisertib?
"Currently, 11 clinical trials assessing the efficacy of Sapanisertib are underway and none have reached Phase 3. Of those, a few are based in Boston, but there are 1,934 additional sites conducting research into this medication."
Is enrollment in this clinical investigation ongoing?
"According to the information hosted on clinicaltrials.gov, this medical trial is not enrolling new patients at this time; the original posting date was May 12th 2014 and it was last updated over a year ago on August 11th 2022. Nevertheless, there are 454 other studies currently advertising for volunteers."
What is the intended outcome of this research endeavor?
"The primary endpoint of this clinical trial, which shall be evaluated over a period spanning up to two years, is the difference in pS6 concentrations between both patient groups. Secondary outcomes comprise inhibition TORC1/2 within tumourous areas (as determined by RPS6 pS235 reverse phase protein array assays) summarised with descriptive statistics or comparison between Groups A and B; correlation assessment between pathway modulation scores and tumour growth using Spearman's coefficient; pharmacodynamic markers like pS6 analysed via immunohistochemistry), p4EBP, pmTOR, AKTpSer473 compared to a control group also through"
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