The purpose of this Phase 1 study is to: 1. determine the maximum tolerated dose of capsules
containing 500mg of freeze dried noni fruit extract, 2. define toxicities associated with the
ingestion of noni, 3. collect preliminary information on the efficacy of noni in respect to
anti-tumor and symptom control properties to help select specific patients for subsequent
Phase 2 studies, 4. identify chemical constituents of the extract that can be used to
characterize the bioavailability and pharmacokinetics of noni food supplement.
Phase:
Phase 1
Details
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)