Trial · NCT03463265
Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma
NCT03463265, Phase 2, Completed, Aadi Bioscience, Inc.; results first posted 2023-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma. Trials, record NCT03463265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03463265
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma
- NCT number
- NCT03463265
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Aadi Bioscience, Inc.
- Conditions
- High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma
- Interventions
- nab-sirolimus, nab-sirolimus + temozolomide, nab-sirolimus + bevacizumab, nab-sirolimus + lomustine, nab-sirolimus + marizomib (MRZ), nab-sirolimus + temozolomide + radiotherapy
- First posted
- 2018-03-13
- Last updated
- 2023-11-07
- Results first posted
- 2023-11-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR | Through study completion (up to 48 months) | 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. |
| Secondary | Median PFS | Through study completion (up to 48 months) | 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. |
| Secondary | PFS Rate at 6 Months and 12 Months | 6 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. |
| Secondary | OS | Through study completion (up to 48 months) | Median Overall Survival |
| Secondary | OS at 12 Months | 12 months | Overall Survival rate at 12 months |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ORR | Through study completion (up to 48 months) | Efficacy Analysis Set | percentage of patients | NUMBER |
| SECONDARY | Median PFS | Through study completion (up to 48 months) | Efficacy Analysis Set | months | MEDIAN |
| SECONDARY | PFS Rate at 6 Months and 12 Months | 6 and 12 months | Efficacy Analysis Set | percentage of patients | NUMBER |
| SECONDARY | OS | Through study completion (up to 48 months) | Efficacy Analysis Set | months | MEDIAN |
| SECONDARY | OS at 12 Months | 12 months | Efficacy Analysis Set | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ORR | Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma | 0 | 95% Confidence Interval NA to NA | percentage of patients | |
| ORR | Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | 0 | 95% Confidence Interval NA to NA | percentage of patients | |
| ORR | Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | 0 | 95% Confidence Interval NA to NA | percentage of patients | |
| ORR | Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | 0 | 95% Confidence Interval NA to NA | percentage of patients | |
| ORR | Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | 0 | 95% Confidence Interval NA to NA | percentage of patients | |
| ORR | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 11.5 | 95% Confidence Interval 2.4 to 30.2 | percentage of patients | |
| Median PFS | Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma | 1.7 | 95% Confidence Interval 1.3 to NA | months | |
| Median PFS | Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | 11.3 | 95% Confidence Interval 5.2 to NA | months | |
| Median PFS | Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | 3.1 | 95% Confidence Interval 1.7 to 9.2 | months | |
| Median PFS | Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | 3.8 | 95% Confidence Interval 1.4 to NA | months |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | 7 | |
| Overall Study | STARTED | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | 6 | |
| Overall Study | STARTED | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | 9 | |
| Overall Study | STARTED | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | 4 | |
| Overall Study | STARTED | ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma | 10 | |
| Overall Study | STARTED | Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 26 | |
| Overall Study | COMPLETED | Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma | 7 | |
| Overall Study | COMPLETED | Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | 6 | |
| Overall Study | COMPLETED | Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | 9 | |
| Overall Study | COMPLETED | Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mucositis | Gastrointestinal disorders | Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma | 4 | 7 | |
| other | Mucositis | Gastrointestinal disorders | Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | 5 | 6 | |
| other | Mucositis | Gastrointestinal disorders | Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | 2 | 9 | |
| other | Mucositis | Gastrointestinal disorders | Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | 2 | 4 | |
| other | Mucositis | Gastrointestinal disorders | Arm A, Cohort 5: Nab-Sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | 1 | 10 | |
| other | Mucositis | Gastrointestinal disorders | Arm B: Nab-Sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 14 | 26 | |
| other | Diarrhea | Gastrointestinal disorders | Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma | 3 | 7 | |
| other | Diarrhea | Gastrointestinal disorders | Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | 1 | 6 | |
| other | Diarrhea | Gastrointestinal disorders | Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | 1 | 9 | |
| other | Diarrhea | Gastrointestinal disorders | Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | 1 | 4 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma | 7 | 7 |
| Total, all-cause mortality | Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | 4 | 6 |
| Total, all-cause mortality | Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | 8 | 9 |
| Total, all-cause mortality | Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | 4 | 4 |
| Total, all-cause mortality | Arm A, Cohort 5: Nab-Sirolimus + Marizomib in Patients With Recurrent High Grade Glioma | 10 | 10 |
| Total, all-cause mortality | Arm B: Nab-Sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma | 19 | 26 |
| Total, other adverse events | Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma | 7 | 7 |
| Total, other adverse events | Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma | 6 | 6 |
| Total, other adverse events | Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma | 8 | 9 |
| Total, other adverse events | Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma | 4 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03463265
GET https://conductscience.org/api/trials/v1/NCT03463265/results?page=2