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

NCT05561023 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-09-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-09-30
Completion
2023-09-30

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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 NCT05561023 on ClinicalTrials.gov