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A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa

NCT02494570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-04-07

Study results available
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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).

Conditions

  • Malignant PEComa

Interventions

DRUG

nab-Sirolimus

Patients received nab-sirolimus at 100 mg/m2 on Days 1 and 8 of a 21-day cycle by intravenous infusion over 30 minutes.

Sponsors & Collaborators

  • Aadi Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Willis Navarro, MD · Aadi Bioscience

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2021-11-30
Completion
2022-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02494570 on ClinicalTrials.gov