NCT05561023

Phase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerance of Hawthorn red pigment in the treatment of cancer pain Determine the maximum tolerated dose (MTD, if any) of Hawthorn red pigment and the recommended dose for phase II clinical study (RP2D)

Conditions

• Hawthorn Red Combined Refractory Cancer Pain

Interventions

Type	Name	Description
DRUG	Hawthorn red pigment	For patients with refractory cancer pain who meet the enrollment conditions, on the basis of the clinician's normal adjustment of the analgesic regimen (the initial adjustment is the first day), the dose ramp up study of Hawthorn red pigment was started on the third day. The Hawthorn red dose group includes 10 tablets → 15 tablets → 20 tablets / time, orally, twice a day. "3 + 3" dose escalation scheme

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-09-30
• Last updated: 2022-09-30