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NOT YET RECRUITING
NCT07130617
PHASE1

Evaluation of the Efficacy and Safety of Megestrol Acetate in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy

Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients

Official title: A Phase Ib, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Clinical Study Evaluating the Efficacy and Safety of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2025-09-29

Completion Date

2026-07-31

Last Updated

2025-08-19

Healthy Volunteers

No

Interventions

DRUG

Low dose of Megestrol Acetate Oral Suspension combined with standard therapy

A single dose of 312.5 mg/day, administered once daily (QD) for 7 consecutive days.

DRUG

Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy

A single dose of 625 mg/day, administered once daily (QD) for 7 consecutive days.

DRUG

High dose of Megestrol Acetate Oral Suspension combined with standard therapy

A single dose of 937.5 mg/day, administered once daily (QD) for 7 consecutive days.

DRUG

Megestrol Acetate Oral Suspension Placebo combined with standard therapy

A single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China