← Back to Search

Protein Synthesis Inhibitor

Arm B: nab-sirolimus + temozolomide + radiotherapy in patients with newly diagnosed glioblastoma for Glioma/Glioblastoma

Phase 2
Waitlist Available
Research Sponsored by Aadi, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

Study Summary

This trial is testing ABI-009, a new drug for brain cancer, either by itself or with other standard treatments.

Eligible Conditions
  • Glioma/Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ORR
Secondary outcome measures
Median PFS
OS
OS at 12 Months
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Arm B: nab-sirolimus + temozolomide + radiotherapy in patients with newly diagnosed glioblastomaExperimental Treatment1 Intervention
Induction Treatment (4 weeks) with nab-sirolimus (60 mg/m2 IV weekly); followed by Concomitant Treatment (standard of care; 2 cycles): nab-sirolimus (60 mg/m2 IV on Days 8 and 15 of every 21-day cycle) in combination with TMZ (75 mg/m2 PO daily for 6 weeks) + radiotherapy (30 × 200 cGy, 5 days/week); followed by Adjuvant Treatment (6 cycles) starting 4 weeks after Concomitant Treatment, with nab-sirolimus(60 mg/m2 IV on Days 1, 8, and 15 of every 28-day cycle) in combination with TMZ (150 mg/m2 PO daily on Days 1-5 of every 28-day cycle)
Group II: Arm A, Cohort 5: nab-sirolimus + marizomib (MRZ) in patients with recurrent high grade gliomaExperimental Treatment1 Intervention
nab-Sirolimus was administered at 60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ was administered at 0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ was administered approximately 10 minutes after the end of the nab-sirolimus infusion.
Group III: Arm A, Cohort 4: nab-sirolimus + lomustine (CCNU) in patients with recurrent high grade gliomaExperimental Treatment1 Intervention
nab-Sirolimus was administered at 60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. CCNU was administered PO at 90 mg/m2 on Day 1 of each odd 21-day cycle (ie, every 6 weeks).
Group IV: Arm A, Cohort 3: nab-sirolimus + bevacizumab in patients with recurrent high grade gliomaExperimental Treatment1 Intervention
nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle). Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle).
Group V: Arm A, Cohort 2: nab-sirolimus + temozolomide (TMZ) in patients with recurrent high grade gliomaExperimental Treatment1 Intervention
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle). Temozolomide (PO at 50 mg/m2 daily)
Group VI: Arm A, Cohort 1: nab-sirolimus in patients with recurrent high grade gliomaExperimental Treatment1 Intervention
nab-Sirolimus (ABI-009, nab-rapamycin, albumin-bound rapamycin) was administered at 100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nab-sirolimus
2018
Completed Phase 2
~130
nab-sirolimus + bevacizumab
2018
Completed Phase 2
~70
nab-sirolimus + temozolomide
2018
Completed Phase 2
~70
nab-sirolimus + lomustine
2018
Completed Phase 2
~70
nab-sirolimus + temozolomide + radiotherapy
2018
Completed Phase 2
~70
nab-sirolimus + marizomib (MRZ)
2018
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Aadi, LLCLead Sponsor
7 Previous Clinical Trials
250 Total Patients Enrolled
Aadi Bioscience, Inc.Lead Sponsor
16 Previous Clinical Trials
479 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma
2018. "Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03463265.
~9 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top