Malignant PEComaPhase 2AMPECTNCT02494570
A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa
A Phase 2 study testing nab-Sirolimus in people with Malignant PEComa, run by Aadi Bioscience, Inc. at 9 sites in United States.
Trial summary
A phase 2 multi-center investigation of efficacy of nab-sirolimus (formerly known as ABI-009 or nab-rapamycin) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant PEComa
- What is being tested?
- nab-Sirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2015to Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histologically confirmed diagnosis of malignant PEComa that is either metastatic or locally advanced and for which surgery is not a recommended option.
- Patients must have available tumor block along with the corresponding pathology report (or approximately 30 unstained slides, with a minimum of 16 slides), and/or fresh biopsy to allow retrospective centralized confirmation of malignant PEComa and for mTOR pathway analysis and biomarker analysis.
- Patients must have one or more measurable target lesions by CT scan or MRI. Measurable disease by RECIST v1.1.
- Patients must not have been previously treated with an mTOR inhibitor.
- Prior treatment (investigational or other), chemotherapy, radiotherapy, surgery, or other therapeutic agents (except mTOR inhibitors) is allowed, if completed after 5 half-lives or ≥28 days prior to enrollment, whichever is shorter.
- Eligible patients, 18 years or older, with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
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- Patients must have the following blood chemistry levels at screening (obtained
- ≤14 days prior to enrollment (local laboratory):
- total bilirubin ≤1.5 x upper limit of normal (ULN) mg/dl
- AST ≤2.5 x ULN (≤5 x ULN if attributable to liver metastases)
- serum creatinine ≤1.5 x ULN
- Adequate biological parameters as demonstrated by the following blood counts at screening (obtained ≤14 days prior to enrollment, local laboratory):
- Absolute neutrophil count (ANC) ≥1.5 × 109/L;
- Platelet count ≥100,000/mm3 (100 × 109/L);
- Hemoglobin ≥9 g/dL.
- Serum triglyceride <300 mg/dL; serum cholesterol < 350 mg/dL.
- Male or non-pregnant and non-breast feeding female:
- Females of child-bearing potential must agree to use effective contraception without interruption from 28 days prior to starting IP and while on study medication and have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment.
- Male patients must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, even if he has undergone a successful vasectomy.
- Life expectancy of >3 months, as determined by the investigator.
- Ability to understand and sign informed consent.
- Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.
Who cannot join
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- Patients with lymphangioleiomyomatosis (LAM) are excluded.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A patient with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases ≥28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
- Active gastrointestinal bleeding, if transfusion dependent.
- Pre-existing thyroid abnormality is allowed provided thyroid function can be controlled with medication.
- Uncontrolled serious medical or psychiatric illness. Patients with a "currently active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score ≤ 6 and postoperative PSA <0.5 ng/mL), or other adequately treated carcinoma-in-situ are ineligible. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥1 year).
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- Liver-directed therapy within 2 months of enrollment. Prior treatment with radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial embolization (with or without chemotherapy) or cyrotherapy/ablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol.
- Recent infection requiring systemic anti-infective treatment that was completed
- ≤14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).
- Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy.
- Unstable coronary artery disease or myocardial infarction during preceding 6 months.
- Receiving any concomitant antitumor therapy.
- Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
- The use of certain medications and illicit drugs within 5 half-lives or 28 days, whichever is shorter prior to the first dose of study drug and for the duration of the study will not be allowed.
- Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to receiving the first dose of ABI-009.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, 27710
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stanford University Medical Center
Palo Alto, California, 94304
Sarcoma Oncology Research Center
Santa Monica, California, 90403
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: A Phase 2 Multi-center Investigation of Efficacy of ABI-009 (Nab-sirolimus) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumors (PEComa)
A phase 2 multi-center investigation of efficacy of nab-sirolimus (formerly known as ABI-009 or nab-rapamycin) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa).
Read the detailed description
This was a phase 2, single-arm, open-label, multi-center study to determine the efficacy and safety profile of nab-sirolimus in patients with advanced malignant PEComa. Patients were required to have measurable disease at baseline (per RECIST v1.1). Eligible patients received nab-sirolimus at 100 mg/m2 by IV infusion (over 30 minutes) weekly for 2 weeks followed by a week of rest (ie, on Day 1 and Day 8 in 21-day cycles). Patients remained on treatment until they experienced progressive disease or unacceptable toxicity, withdrew consent, or physician's decision. Patients who discontinued treatment entered the on-study Follow-up period for survival.
Computed tomography or magnetic resonance imaging (MRI) scans were performed at screening, every 6 weeks for the first year, then every 12 weeks thereafter until the end of treatment. Throughout treatment with nab-sirolimus, patients were routinely assessed for toxicities, the need for dose modifications, and response assessments.
The sample size was targeted to be ~30 patients in order to provide a reasonably precise estimate of the true ORR. Assuming an observed ORR of 30% and a sample size of 30, the lower bound of the 95% confidence interval (CI) for the estimated ORR would exclude values less than 14.7%.
The primary analysis was predefined to be conducted when all patients have had the opportunity to be treated for at least 6 months. The study remained open for 3 additional years and the final analysis occured at study closure.
- Conditions
- Malignant PEComa
- Being tested
- nab-Sirolimus
- Keywords
- malignant PEComa, perivascular epithelioid cell tumors
- Medical subject headings
- Perivascular Epithelioid Cell Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-SirolimusDrug
Also called ABI-009, Fyarro, nab-rapamycin
Patients received nab-sirolimus at 100 mg/m2 on Days 1 and 8 of a 21-day cycle by intravenous infusion over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| nab-Sirolimus | Experimental | Patients with malignant PEComa received nab-sirolimus on Days 1 and 8 of every 21-day cycle, as a 30-minute IV infusion. Receives: Drug: nab-Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Overall Response Rate (ORR)
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.
Measured: through study completion (up to 72 months)
Secondary outcomes (4)
Duration of Response
The time from the start of CR or PR to the first date of documented PD or death.
Measured: From Initial response until tumor progression, through study completion (up to 72 months)
Progression-free Survival Rate at 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).
Measured: 6 months
Progression-free Survival (Median)
The time from the first dose date to the first observation of a disease progression or death due to any cause.
Measured: from start of treatment to first documented disease progression, through study completion (up to 72 months)
Overall Survival
Defined as teh time from first dose date to the date of death due to any cause
Measured: From start of treatment to date of death (of any cause), through study completion (up to 72 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2021
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant PEComaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aadi Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Willis Navarro, MD, Study director, Aadi Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494570
- Sponsor's protocol ID
- PEC-001
- Other IDs
- FD005749, AMPECT
- Acronym
- AMPECT
- Status last verified
- Mar 2023
- First submitted
- 8 Jul 2015
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Publications
Wagner AJ, Ravi V, Riedel RF, Ganjoo K, Van Tine BA, Chugh R, Cranmer L, Gordon EM, Hornick JL, Du H, Polson KM, Yalamanchili S, DeBoer C, Ding L, Schmid AN, Navarro WH, Kwiatkowski DJ, Dickson MA. A plain language summary of the AMPECT study: nab-sirolimus for advanced malignant perivascular epithelioid cell tumors. Future Oncol. 2026 Jan;22(1):1-13. doi: 10.1080/14796694.2025.2574811. Epub 2025 Dec 22.
PubMed 41424265Wagner AJ, Ravi V, Riedel RF, Ganjoo K, Van Tine BA, Chugh R, Cranmer L, Gordon EM, Hornick JL, Du H, Ding L, Schmid AN, Navarro WH, Kwiatkowski DJ, Dickson MA. Phase II Trial of nab-Sirolimus in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumors (AMPECT): Long-Term Efficacy and Safety Update. J Clin Oncol. 2024 May 1;42(13):1472-1476. doi: 10.1200/JCO.23.02266. Epub 2024 Mar 1.
PubMed 38427923Wagner AJ, Ravi V, Riedel RF, Ganjoo K, Van Tine BA, Chugh R, Cranmer L, Gordon EM, Hornick JL, Du H, Grigorian B, Schmid AN, Hou S, Harris K, Kwiatkowski DJ, Desai NP, Dickson MA. nab-Sirolimus for Patients With Malignant Perivascular Epithelioid Cell Tumors. J Clin Oncol. 2021 Nov 20;39(33):3660-3670. doi: 10.1200/JCO.21.01728. Epub 2021 Oct 12.
PubMed 34637337
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-center Investigation of Efficacy of ABI-009 (Nab-sirolimus) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumors (PEComa)
- ClinicalTrials.gov ID
- NCT02494570
- Acronym / sponsor ID
- AMPECT / PEC-001
- Conditions
- Malignant PEComa
- Keywords
- malignant PEComa, perivascular epithelioid cell tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Aadi Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Nov 2021 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 multi-center investigation of efficacy of nab-sirolimus (formerly known as ABI-009 or nab-rapamycin) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa).
Detailed description
This was a phase 2, single-arm, open-label, multi-center study to determine the efficacy and safety profile of nab-sirolimus in patients with advanced malignant PEComa. Patients were required to have measurable disease at baseline (per RECIST v1.1). Eligible patients received nab-sirolimus at 100 mg/m2 by IV infusion (over 30 minutes) weekly for 2 weeks followed by a week of rest (ie, on Day 1 and Day 8 in 21-day cycles). Patients remained on treatment until they experienced progressive disease or unacceptable toxicity, withdrew consent, or physician's decision. Patients who discontinued treatment entered the on-study Follow-up period for survival.
Computed tomography or magnetic resonance imaging (MRI) scans were performed at screening, every 6 weeks for the first year, then every 12 weeks thereafter until the end of treatment. Throughout treatment with nab-sirolimus, patients were routinely assessed for toxicities, the need for dose modifications, and response assessments.
The sample size was targeted to be ~30 patients in order to provide a reasonably precise estimate of the true ORR. Assuming an observed ORR of 30% and a sample size of 30, the lower bound of the 95% confidence interval (CI) for the estimated ORR would exclude values less than 14.7%.
The primary analysis was predefined to be conducted when all patients have had the opportunity to be treated for at least 6 months. The study remained open for 3 additional years and the final analysis occured at study closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-Sirolimus | Experimental | Drug: nab-SirolimusPatients with malignant PEComa received nab-sirolimus on Days 1 and 8 of every 21-day cycle, as a 30-minute IV infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients must have a histologically confirmed diagnosis of malignant PEComa that is either metastatic or locally advanced and for which surgery is not a recommended option.
- Patients must have available tumor block along with the corresponding pathology report (or approximately 30 unstained slides, with a minimum of 16 slides), and/or fresh biopsy to allow retrospective centralized confirmation of malignant PEComa and for mTOR pathway analysis and biomarker analysis.
- Patients must have one or more measurable target lesions by CT scan or MRI. Measurable disease by RECIST v1.1.
- Patients must not have been previously treated with an mTOR inhibitor.
- Prior treatment (investigational or other), chemotherapy, radiotherapy, surgery, or other therapeutic agents (except mTOR inhibitors) is allowed, if completed after 5 half-lives or ≥28 days prior to enrollment, whichever is shorter.
Key exclusion criteria (15 listed)
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- Patients with lymphangioleiomyomatosis (LAM) are excluded.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A patient with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases ≥28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
- Active gastrointestinal bleeding, if transfusion dependent.
- Pre-existing thyroid abnormality is allowed provided thyroid function can be controlled with medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-SirolimusAlso: ABI-009, Fyarro, nab-rapamycinPatients received nab-sirolimus at 100 mg/m2 on Days 1 and 8 of a 21-day cycle by intravenous infusion over 30 minutes. | Drug | nab-Sirolimus |
Primary outcome
Objective Overall Response Rate (ORR)
Time frame: 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.
4 secondary outcomes
Duration of Response
Time frame: From Initial response until tumor progression, through study completion (up to 72 months)
Progression-free Survival Rate at 6 Months
Time frame: 6 months
Progression-free Survival (Median)
Time frame: from start of treatment to first documented disease progression, through study completion (up to 72 months)
Overall Survival
Time frame: From start of treatment to date of death (of any cause), through study completion (up to 72 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41424265Wagner AJ, Ravi V, Riedel RF, Ganjoo K, Van Tine BA, Chugh R, Cranmer L, Gordon EM, Hornick JL, Du H, Polson KM, Yalamanchili S, DeBoer C, Ding L, Schmid AN, Navarro WH, Kwiatkowski DJ, Dickson MA. A plain language summary of the AMPECT study: nab-sirolimus for advanced malignant perivascular epithelioid cell tumors. Future Oncol. 2026 Jan;22(1):1-13. doi: 10.1080/14796694.2025.2574811. Epub 2025 Dec 22.
- Derived from this study: PubMed 38427923Wagner AJ, Ravi V, Riedel RF, Ganjoo K, Van Tine BA, Chugh R, Cranmer L, Gordon EM, Hornick JL, Du H, Ding L, Schmid AN, Navarro WH, Kwiatkowski DJ, Dickson MA. Phase II Trial of nab-Sirolimus in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumors (AMPECT): Long-Term Efficacy and Safety Update. J Clin Oncol. 2024 May 1;42(13):1472-1476. doi: 10.1200/JCO.23.02266. Epub 2024 Mar 1.
- Derived from this study: PubMed 34637337Wagner AJ, Ravi V, Riedel RF, Ganjoo K, Van Tine BA, Chugh R, Cranmer L, Gordon EM, Hornick JL, Du H, Grigorian B, Schmid AN, Hou S, Harris K, Kwiatkowski DJ, Desai NP, Dickson MA. nab-Sirolimus for Patients With Malignant Perivascular Epithelioid Cell Tumors. J Clin Oncol. 2021 Nov 20;39(33):3660-3670. doi: 10.1200/JCO.21.01728. Epub 2021 Oct 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willis Navarro, MD study director
Aadi Bioscience
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-Sirolimus in people with Malignant PEComa, run by Aadi Bioscience, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Overall Response Rate (ORR) (time frame: through study completion (up to 72 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02494570, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.