A Phase 2 interventional study of nab-sirolimus and nab-sirolimus + temozolomide in High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma, sponsored by Aadi Bioscience, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Aadi Bioscience, Inc. · Phase 2, Interventional, and Treatment
Phase 2, open-label study of nab-sirolimus in patients with recurrent high grade glioma following prior therapy and patients with newly diagnosed glioblastoma. nab-Sirolimus was administered as single agent or in combination therapies.
A phase 2, open-label study of nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin) in patients with recurrent high grade glioma following prior therapy and patients with newly diagnosed glioblastoma. nab-Sirolimus was administered as single agent or in combination therapies, including temozolomide, bevacizumab, lomustine, and marizomib.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's enrollment of 62 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Aadi Bioscience, Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Specific for Arm A
Inclusion Criteria Specific for Arm B
Exclusion Criteria Common for Both Arms A and B
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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)
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
nab-sirolimus, single agent
Drug pages: Sirolimus Albumin-bound Nanoparticles · Temozolomide
temozolomide, combination
Also known as: nab-sirolimus, temozolomide
Drug pages: Sirolimus Albumin-bound Nanoparticles · Bevacizumab
bevacizumab, combination
Also known as: nab-sirolimus, bevacizumab
Drug pages: Sirolimus Albumin-bound Nanoparticles · Lomustine
lomustine, combination
Also known as: nab-sirolimus, lomustine (CCNU)
Drug pages: Sirolimus Albumin-bound Nanoparticles · Marizomib
marizomib (MRZ), combination
Also known as: nab-sirolimus, marizomib (MRZ)
Drug pages: Sirolimus Albumin-bound Nanoparticles · Temozolomide
temozolomide + radiotherapy, combination
Also known as: nab-sirolimus, temozolomide, radiation
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)
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)
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
OS
Median Overall Survival
Time frame: Through study completion (up to 48 months)
OS at 12 Months
Overall Survival rate at 12 months
Time frame: 12 months
| Milestone | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma |
|---|---|---|---|---|---|---|
| Started | 7 | 6 | 9 | 4 | 10 | 26 |
| Completed | 7 | 6 | 9 | 4 | 10 | 26 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| percentage of patients | Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma |
|---|---|---|---|---|---|---|
| ORR | 0 (NA to NA) | 0 (NA to NA) | 0 (NA to NA) | 0 (NA to NA) | 0 (NA to NA) | 11.5 (2.4 to 30.2) |
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.
| months | Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma |
|---|---|---|---|---|---|---|
| Median PFS | 1.7 (1.3 to NA) | 11.3 (5.2 to NA) | 3.1 (1.7 to 9.2) | 3.8 (1.4 to NA) | 1.7 (0.9 to 3.5) | 7.5 (6.2 to 14.4) |
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.
| percentage of patients | Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma |
|---|---|---|---|---|---|---|
| PFS at 6 months | 0.0 (NA to NA) | 75.0 (12.8 to 96.1) | 37.5 (8.7 to 67.4) | 25.0 (0.9 to 66.5) | 10.0 (0.6 to 35.8) | 76.9 (55.7 to 88.9) |
| PFS at 12 months | 0.0 (NA to NA) | 50.0 (5.8 to 84.5) | 12.5 (0.7 to 42.3) | 0.0 (NA to NA) | 0.0 (NA to NA) | 36.4 (18.5 to 54.7) |
Median Overall Survival
| months | Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Gliom | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma |
|---|---|---|---|---|---|---|
| OS | 7.2 (2.7 to NA) | 13.8 (5.2 to NA) | 6.8 (1.7 to 13.1) | 7.5 (5.4 to NA) | 6.7 (1.7 to 9.2) | 13.3 (7.9 to 23.2) |
Overall Survival rate at 12 months
| percentage of patients | Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma |
|---|---|---|---|---|---|---|
| OS at 12 Months | 0.0 (NA to NA) | 66.7 (19.5 to 90.4) | 25.0 (3.7 to 55.8) | 25.0 (0.9 to 66.5) | 0.0 (NA to NA) | 53.8 (33.3 to 70.6) |
Collected over Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma | 7/7 (100%) | 0/7 (0%) | 7/7 (100%) |
| Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | 4/6 (66.7%) | 0/6 (0%) | 6/6 (100%) |
| Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | 8/9 (88.9%) | 0/9 (0%) | 8/9 (88.9%) |
| Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | 4/4 (100%) | 1/4 (25%) | 4/4 (100%) |
| Arm A, Cohort 5: Nab-Sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | 10/10 (100%) | 0/10 (0%) | 10/10 (100%) |
| Arm B: Nab-Sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 19/26 (73.1%) | 1/26 (3.8%) | 26/26 (100%) |
| Event | Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma | Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | Arm A, Cohort 5: Nab-Sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | Arm B: Nab-Sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma |
|---|---|---|---|---|---|---|
| Myelosuppression (thrombocytopenia)Blood and lymphatic system disorders | 0/7 | 0/6 | 0/9 | 1/4 | 0/10 | 0/26 |
| Myelossupression (neutropenia)Blood and lymphatic system disorders | 0/7 | 0/6 | 0/9 | 1/4 | 0/10 | 0/26 |
| PneumoniaInfections and infestations | 0/7 | 0/6 | 0/9 | 0/4 | 0/10 | 1/26 |
| SepsisInfections and infestations | 0/7 | 0/6 | 0/9 | 0/4 | 0/10 | 1/26 |
| EncephalopathyNervous system disorders | 0/7 | 0/6 | 0/9 | 0/4 | 0/10 | 1/26 |
| Event | Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma | Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | Arm A, Cohort 5: Nab-Sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | Arm B: Nab-Sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma |
|---|---|---|---|---|---|---|
| MucositisGastrointestinal disorders | 4/7 | 5/6 | 2/9 | 2/4 | 1/10 | 14/26 |
| RashSkin and subcutaneous tissue disorders | 3/7 | 5/6 | 3/9 | 3/4 | 3/10 | 12/26 |
| Myelosuppression (thrombocytopenia)Blood and lymphatic system disorders | 2/7 | 3/6 | 5/9 | 3/4 | 7/10 | 14/26 |
| FatigueGeneral disorders | 2/7 | 2/6 | 3/9 | 2/4 | 2/10 | 9/26 |
| DiarrheaGastrointestinal disorders | 3/7 | 1/6 | 1/9 | 1/4 | 1/10 | 2/26 |
| VomitingGastrointestinal disorders | 0/7 | 2/6 | 0/9 | 0/4 | 4/10 | 2/26 |
| NauseaGastrointestinal disorders | 1/7 | 2/6 | 0/9 | 1/4 | 2/10 | 3/26 |
| HypertriglyceridemiaMetabolism and nutrition disorders | 0/7 | 2/6 | 2/9 | 0/4 | 1/10 | 5/26 |
| Decreased appetiteMetabolism and nutrition disorders | 0/7 | 2/6 | 0/9 | 0/4 | 0/10 | 6/26 |
| Myelossupression (neutropenia)Blood and lymphatic system disorders | 0/7 | 2/6 | 0/9 | 1/4 | 2/10 | 3/26 |
Full analysis set
| Age, Categorical(Participants) | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 7 | 4 | 9 | 13 | 42 |
| >=65 years | 2 | 2 | 2 | 0 | 1 | 13 | 20 |
| Age, Continuous(years) | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | Total |
|---|---|---|---|---|---|---|---|
| Median | 60 (36 to 78) | 53.5 (34 to 71) | 60 (45 to 70) | 53 (38 to 59) | 52.5 (27 to 72) | 64 (27 to 80) | 60 (27 to 80) |
| Sex: Female, Male(Participants) | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | Total |
|---|---|---|---|---|---|---|---|
| Female | 2 | 2 | 1 | 1 | 3 | 6 | 15 |
| Male | 5 | 4 | 8 | 3 | 7 | 20 | 47 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 4 | 3 | 0 | 3 | 3 | 13 |
| Not Hispanic or Latino | 6 | 2 | 6 | 4 | 7 | 23 | 48 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 0 | 0 | 0 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 5 | 6 | 9 | 4 | 9 | 25 | 58 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | Total |
|---|---|---|---|---|---|---|---|
| United States | 7 | 6 | 9 | 4 | 10 | 26 | 62 |
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Studies of the drugs tested here: Sirolimus Albumin-bound Nanoparticles · Temozolomide · Bevacizumab · Lomustine · Marizomib
Aadi Bioscience, Inc.