Trial · NCT02494570
A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa
NCT02494570, Phase 2, Completed, Aadi Bioscience, Inc.; results first posted 2023-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa. Trials, record NCT02494570. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02494570
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa
- NCT number
- NCT02494570
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Aadi Bioscience, Inc.
- Conditions
- Malignant PEComa
- Interventions
- nab-Sirolimus
- First posted
- 2015-07-10
- Last updated
- 2023-04-07
- Results first posted
- 2023-04-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Overall Response Rate (ORR) | through study completion (up to 72 months) | Best ORR was assessed by Independent Radiology Review using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria. Best overall response was the best response recorded from the start of the study treatment until the end of treatment taking into account the requirement for confirmation. Per RECIST v1.1, best overall response assignment depended on the findings of both target and non-target disease and also took into consideration the appearance of new lesions. Overall response rate was defined as the percentage of patients who achieve a confirmed PR or CR per RECIST 1.1. At each timepoint, objective tumor response for target lesions were assessed as such: Complete Response (CR), disappearance of all target lesions, and pathological lymph nodes must have a reduction \<10 mm; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions. |
| Secondary | Duration of Response | From Initial response until tumor progression, through study completion (up to 72 months) | The time from the start of CR or PR to the first date of documented PD or death. |
| Secondary | Progression-free Survival Rate at 6 Months | 6 months | The time from the first dose date to the first observation of a disease progression or death due to any cause by 6 mo. Disease progression was assessed radiologically per RECIST v1.1, and was defined as ≥20% increase in the sum of diameters of target lesions, and absolute increase of ≥5 mm. PFS rate at 6 months was summarized using Kaplan-Meier methods (percentage rounded up to 1 digit decimal). |
| Secondary | Progression-free Survival (Median) | from start of treatment to first documented disease progression, through study completion (up to 72 months) | The time from the first dose date to the first observation of a disease progression or death due to any cause. |
| Secondary | Overall Survival | From start of treatment to date of death (of any cause), through study completion (up to 72 months) | Defined as teh time from first dose date to the date of death due to any cause |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Overall Response Rate (ORR) | through study completion (up to 72 months) | Efficacy Evaluable Patient Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | From Initial response until tumor progression, through study completion (up to 72 months) | Patients with a confirmed partial or complete response | months | MEDIAN |
| SECONDARY | Progression-free Survival Rate at 6 Months | 6 months | Efficacy Evaluable Patient Population | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (Median) | from start of treatment to first documented disease progression, through study completion (up to 72 months) | Efficacy Evaluable Patient Population | months | MEDIAN |
| SECONDARY | Overall Survival | From start of treatment to date of death (of any cause), through study completion (up to 72 months) | Treated Patient Population | months | MEDIAN |
| POST_HOC | Disease Control Rate | through study completion (up to 72 months) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Overall Response Rate (ORR) | Nab-Sirolimus | Best Overall Confirmed Complete Response | 2 | Participants | |
| Objective Overall Response Rate (ORR) | Nab-Sirolimus | Best Overall Confirmed Partial Response | 10 | Participants | |
| Objective Overall Response Rate (ORR) | Nab-Sirolimus | Best Overall Stable Disease | 16 | Participants | |
| Objective Overall Response Rate (ORR) | Nab-Sirolimus | Best Overall Progressive Disease | 3 | Participants | |
| Duration of Response | Experimental: Nab-Sirolimus | 39.7 | 95% Confidence Interval 6.5 to NA | months | |
| Progression-free Survival Rate at 6 Months | Experimental: Nab-Sirolimus | 69.5 | 95% Confidence Interval 47.6 to 83.7 | percentage of participants | |
| Progression-free Survival (Median) | Experimental: Nab-Sirolimus | 10.6 | 95% Confidence Interval 5.5 to 53.1 | months | |
| Overall Survival | Experimental: Nab-Sirolimus | 53.1 | 95% Confidence Interval 22.2 to NA | months | |
| Disease Control Rate | Experimental: Nab-Sirolimus | 10 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental: Nab-Sirolimus | 34 | |
| Overall Study | COMPLETED | Experimental: Nab-Sirolimus | 34 | |
| Overall Study | NOT COMPLETED | Experimental: Nab-Sirolimus | 0 |
Source ClinicalTrials.gov
Adverse events77
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 | Stomatitis | Gastrointestinal disorders | Experimental: Nab-Sirolimus | 28 | 34 | 69 |
| other | Nausea | Gastrointestinal disorders | Experimental: Nab-Sirolimus | 17 | 34 | 40 |
| other | Diarrhoea | Gastrointestinal disorders | Experimental: Nab-Sirolimus | 16 | 34 | 39 |
| other | Abdominal Pain | Gastrointestinal disorders | Experimental: Nab-Sirolimus | 15 | 34 | 33 |
| other | Vomiting | Gastrointestinal disorders | Experimental: Nab-Sirolimus | 13 | 34 | 31 |
| other | Fatigue | General disorders | Experimental: Nab-Sirolimus | 25 | 34 | 47 |
| other | Edema | General disorders | Experimental: Nab-Sirolimus | 19 | 34 | 32 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Experimental: Nab-Sirolimus | 16 | 34 | 45 |
| other | Decreased appetite | Metabolism and nutrition disorders | Experimental: Nab-Sirolimus | 15 | 34 | 21 |
| other | Hypokalemia | Metabolism and nutrition disorders | Experimental: Nab-Sirolimus | 15 | 34 | 33 |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: Nab-Sirolimus | 2 | 34 |
| Total, other adverse events | Experimental: Nab-Sirolimus | 34 | 34 |
| Total, serious adverse events | Experimental: Nab-Sirolimus | 16 | 34 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT02494570
GET https://conductscience.org/api/trials/v1/NCT02494570/events?page=2