Spots Global Cancer Trial Database for APG-115 in Salivary Gland Cancer Trial
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Trial Identification
Brief Title: APG-115 in Salivary Gland Cancer Trial
Official Title: A Multicenter Phase I/II Trial of a Novel MDM2 Inhibitor (APG-115) in p53 Wild-type Salivary Gland Carcinoma
Study ID: NCT03781986
Study Description
Brief Summary: This is a phase I/II trial to evaluate the efficacy of APG-115 +/- Carboplatin for the treatment p53 wild-type malignant salivary gland cancer. Part 1 consisted of 2 arms, arm A (APG-115 monotherapy) and arm B (APG-115 + Carboplatin) and was terminated early. Part 2 is a single arm study (APG-115 monotherapy).
Detailed Description: The current single arm study design was originally part of a study with a parallel arm given combination APG-115 + Carboplatin. In the initial phase of that previous iteration, the combination arm was closed early for issues related to tolerability of the combination therapy. This study will continue as a single arm, monotherapy alone, Phase I/II study as approved by the UM Institutional Review Board as of June 2021.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago, Chicago, Illinois, United States
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
Contact Details
Name: Paul L Swiecicki, MD
Affiliation: University of Michigan Rogel Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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