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Brief Title: Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
Official Title: (STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
Study ID: NCT02355535
Brief Summary: This Phase I dose escalation study will evaluate Procaspase Activating Compound-1 (PAC-1), a small molecule that activates procaspase -3 to caspase-3, resulting in apoptosis of cancer cells, in patients with advanced malignancies. As of March 1, 2019, only patients with neuroendocrine tumors will be enrolled in Component 1 of this study. PAC-1 is taken orally on days 1-21 of a 28-day cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined using a modified-Fibonacci dose-escalation 3+3 design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Illinois at Chicago, Chicago, Illinois, United States
Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland, United States
Regions Hospital, Saint Paul, Minnesota, United States
Name: Oana C Danciu, M.D.
Affiliation: University of Illinois at Chicago
Role: PRINCIPAL_INVESTIGATOR