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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566834 on ClinicalTrials.gov