Clinical Trial: A Phase 2 Study of ABI-009 in Patients With Advanced Malignant PEComa
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2 Multi-center Investigation of Efficacy of ABI-009 (Nab-rapamycin) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumors (
Brief Summary: A phase 2 multi-center investigation of efficacy of ABI-009 (nab-rapamycin) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa)
Detailed Summary:
Sponsor: Aadi, LLC
Current Primary Outcome: objective response rate [ Time Frame: up to 32 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of response [ Time Frame: From Initial response until tumor progression, up to 32 months ]
- Progression free rate at 6 months [ Time Frame: 6 months ]
- Progression free survival [ Time Frame: from start of treatment to first documented disease progression, up to 32 months ]
- Overall survival [ Time Frame: From start of treatment to date of death (of any cause), up to 32 months ]
- Number of participants with Adverse events [ Time Frame: up to 32 months ]
Original Secondary Outcome: Same as current
Information By: Aadi, LLC
Dates:
Date Received: July 8, 2015
Date Started: October 2015
Date Completion: September 2020
Last Updated: September 26, 2016
Last Verified: September 2016
