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Protein Synthesis Inhibitor

Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed 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

No Placebo-Only Group

Summary

This trial tests nab-Sirolimus, a drug for treating difficult brain tumors. It targets patients with specific types of aggressive brain tumors. The drug works by blocking pathways that help tumors grow.

Eligible Conditions

Brain Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ORR

Secondary study objectives

Median PFS

OS at 12 Months

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2017

Completed Phase 2

~140

nab-sirolimus + temozolomide

2018

Completed Phase 2

~70