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mTOR Inhibitor

Pre- and Post-Surgery Sapanisertib for Brain Cancer

Phase 1
Waitlist Available
Led By Eudocia Q Lee
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically proven glioblastoma or gliosarcoma which is progressive or recurrent following radiation therapy +/- chemotherapy
Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with recurrent glioblastoma or gliosarcoma who need surgery. They must have had no more than two prior relapses, be able to undergo MRI scans, and have certain blood and organ function levels within normal ranges. Women of childbearing age must test negative for pregnancy and use contraception, as should men. Those with other cancers or uncontrolled diseases are excluded.Check my eligibility
What is being tested?
The study tests how well sapanisertib works when given before and after brain tumor surgery in patients with recurrent glioblastoma. It's a phase I trial to see the drug's effect on stopping tumor growth by inhibiting enzymes needed for cell growth.See study design
What are the potential side effects?
While specific side effects of sapanisertib aren't listed here, similar drugs can cause fatigue, nausea, liver issues, blood clots, high blood sugar levels (in diabetics), rash or skin conditions. Patients will be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor has returned or worsened after treatment.
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I have no other cancers except possibly treated skin cancer.
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I can care for myself but may need occasional help.
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I am eligible for surgery based on my doctor's assessment.
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I can swallow pills without any issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in ratio of the S6 phosphorylation over the total between the two groups
Difference of the pS6 concentration between the two groups
Proportion of patients who achieve a drug concentration >= 70 nM in contrast enhancing tumor tissue
Secondary outcome measures
Incidence of toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Inhibition TORC1/2 in the non-enhancing components of the tumor as determined by modulation of RPS6 pS235 in reverse phase protein array (RPPA) assays
Overall survival (death)
+5 more
Other outcome measures
Ex-vivo sensitivity of tumor sphere cultures established from surgical specimens to sapanisertib, defined by a minimum of 20% reduction in cell proliferation as measured by cell titer glow in the sapanisertib group compared to the untreated group
MSI from treated versus (vs) untreated enhancing and non- enhancing tumor
Tumor genotype

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (sapanisertib after surgery)Experimental Treatment4 Interventions
Patients undergo surgery on day 0. Within 45 days after surgery, patients receive sapanisertib PO according to the results from Part I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (sapanisertib before and after surgery)Experimental Treatment4 Interventions
Patients receive sapanisertib PO according to the results from Part I. Patients also undergo surgery on day 0. Within 45 days after surgery, patients receive sapanisertib PO according to the results from Part I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sapanisertib
2016
Completed Phase 2
~840
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,603 Previous Clinical Trials
40,913,235 Total Patients Enrolled
314 Trials studying Glioblastoma
22,406 Patients Enrolled for Glioblastoma
Eudocia Q LeePrincipal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
211 Total Patients Enrolled
2 Trials studying Glioblastoma
211 Patients Enrolled for Glioblastoma

Media Library

Sapanisertib (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02133183 — Phase 1
Glioblastoma Research Study Groups: Arm I (sapanisertib before and after surgery), Arm II (sapanisertib after surgery)
Glioblastoma Clinical Trial 2023: Sapanisertib Highlights & Side Effects. Trial Name: NCT02133183 — Phase 1
Sapanisertib (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02133183 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
~4 spots leftby Mar 2025