NCT07130617

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This multicenter, randomized, double-blind, placebo-controlled parallel-group study evaluates the efficacy, safety, and pharmacokinetic profile of megestrol acetate oral suspension in preventing nausea and vomiting induced by highly emetogenic chemotherapy. The trial plans to enroll 132 chemotherapy-naive malignant solid tumor patients scheduled to undergo initial single-day highly emetogenic chemotherapy regimens.

Conditions

• Efficacy
• Safety
• Megestrol Acetate
• Adult Subject

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-29
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: China