NCT05566834

Minnelide™ Capsules Alone and in Combination With Paclitaxel in Advanced Gastric Cancer

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Minneamrita Therapeutics LLC · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Minnelide™ is a water soluble disodium salt variant of triptolide, a diterpenoid, an HSP70 inhibitor. Studies using orthotopic pancreatic cancer cell lines and human xenograft transplants demonstrate that Minnelide™ prevents tumor progression, increases survival, and causes tumor regression.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-02
• Primary completion: 2024-06-01
• Completion: 2024-11-01
• First posted: 2022-10-04
• Last updated: 2023-10-18

Locations

1 site across 1 country: South Korea