Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma

Browse trials for

• Glioblastoma 1,917
• Glioma 1,395
• Recurrence 4,274

Eligibility criteria

Study arms

• Experimental
  Arm A, Cohort 1: nab-sirolimus in patients with recurrent high grade glioma

  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.

  Drug: nab-sirolimus

• Experimental
  Arm A, Cohort 2: nab-sirolimus + temozolomide (TMZ) in patients with recurrent high grade glioma

  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)

  Drug: nab-sirolimus + temozolomide

• Experimental
  Arm A, Cohort 3: nab-sirolimus + bevacizumab in patients with recurrent high grade glioma

  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).

  Drug: nab-sirolimus + bevacizumab

• Experimental
  Arm A, Cohort 4: nab-sirolimus + lomustine (CCNU) in patients with recurrent high grade glioma

  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).

  Drug: nab-sirolimus + lomustine

• Experimental
  Arm A, Cohort 5: nab-sirolimus + marizomib (MRZ) in patients with recurrent high grade glioma

  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.

  Drug: nab-sirolimus + marizomib (MRZ)

• Experimental
  Arm B: nab-sirolimus + temozolomide + radiotherapy in patients with newly diagnosed glioblastoma

  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)

  Drug: nab-sirolimus + temozolomide + radiotherapy

Interventions

• Drugnab-sirolimus

  nab-sirolimus, single agent

• Drugnab-sirolimus + temozolomide

  temozolomide, combination

  Also known as: nab-sirolimus, temozolomide

• Drugnab-sirolimus + bevacizumab

  bevacizumab, combination

  Also known as: nab-sirolimus, bevacizumab

• Drugnab-sirolimus + lomustine

  lomustine, combination

  Also known as: nab-sirolimus, lomustine (CCNU)

• Drugnab-sirolimus + marizomib (MRZ)

  marizomib (MRZ), combination

  Also known as: nab-sirolimus, marizomib (MRZ)

• Drugnab-sirolimus + temozolomide + radiotherapy

  temozolomide + radiotherapy, combination

  Also known as: nab-sirolimus, temozolomide, radiation

Primary outcomes

1. ORR

   Objective overall response rate (ORR, according to Response Assessment in Neuro-Oncology \[RANO\]) by investigator-assessed radiologic review and defined as the proportion of patients who achieved a confirmed partial response (PR) or confirmed complete response (CR) per RANO 2010 criteria. PR is defined as greater than or equal to 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks.

   Time frame: Through study completion (up to 48 months)

Secondary outcomes

1. Median PFS

   Progression-free Survival defined as number of months from the date of the first dose of study drug to the first observation of a disease progression or death due to any cause. Progression is assessed according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria based on MRI imaging, and includes ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids.

   Time frame: Through study completion (up to 48 months)

2. PFS Rate at 6 Months and 12 Months

   Progression-free survival rate at 6 months and 12 months was calculated as the proportion of patients who were progression-free and alive at 6 and 12 months, respectively. Progression is assessed according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria based on MRI imaging, and includes ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids.

   Time frame: 6 and 12 months

3. OS

   Median Overall Survival

   Time frame: Through study completion (up to 48 months)

4. OS at 12 Months

   Overall Survival rate at 12 months

   Time frame: 12 months

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Dec 2, 2019

Documents are hosted by the registry — open the source record to download them.