Minnelide™ Capsules Alone and in Combination With Paclitaxel in Advanced Gastric Cancer
NCT05566834 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2023-10-18
Summary
A Phase 1, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™ Capsules given alone or in combination with paclitaxel in patients with Advanced Gastric Cancer.
Conditions
Interventions
- DRUG
-
Minnelide
at the MTD dose level established for monotherapy or combination to confirm safety. With a sample of 12 patients, the probability is \> 80% that a serious adverse event with at least a 16% incidence will be detected.
Sponsors & Collaborators
-
Minneamrita Therapeutics LLC
lead INDUSTRY
Principal Investigators
-
Mohana Velagapudi · Minneamrita Therapeutics LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-02
- Primary Completion
- 2024-06-30
- Completion
- 2024-11-30
Countries
- South Korea
Study Locations
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