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

NCT07130617 | Not Yet Recruiting Phase 1

• 1 other identifier: GenSci158-101
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Efficacy; Safety; Megestrol Acetate; Adult Subject

Outcome Measures

Primary Outcomes (2)

• Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle

  From 0 to 168 Hours After Initiation of Chemotherapy

• Proportion of Subjects Experiencing No Nausea During 0-120 Hours After Initiation of the First Chemotherapy Cycle

  From 0 to 120 Hours After Initiation of Chemotherapy

Secondary Outcomes (1)

• Proportion of Subjects Achieving Complete Response (No significant nausea, No vomiting, etc. ) in the Acute, Delayed, Extended Delayed, 0-120 h, and 0-168 h Phases During the First Chemotherapy Cycle

  From 0 to 168 Hours After Initiation of Chemotherapy

Study Arms (4)

Low dose of Megestrol Acetate Oral Suspension

EXPERIMENTAL

Drug: Low dose of Megestrol Acetate Oral Suspension combined with standard therapy

Medium dose of Megestrol Acetate Oral Suspension

EXPERIMENTAL

Drug: Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy

High dose of Megestrol Acetate Oral Suspension

EXPERIMENTAL

Drug: High dose of Megestrol Acetate Oral Suspension combined with standard therapy

Megestrol Acetate Oral Suspension Placebo

ACTIVE COMPARATOR

Drug: Megestrol Acetate Oral Suspension Placebo combined with standard therapy

Interventions

Low dose of Megestrol Acetate Oral Suspension combined with standard therapy DRUG

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

Low dose of Megestrol Acetate Oral Suspension

Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy DRUG

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

Medium dose of Megestrol Acetate Oral Suspension

High dose of Megestrol Acetate Oral Suspension combined with standard therapy DRUG

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

High dose of Megestrol Acetate Oral Suspension

Megestrol Acetate Oral Suspension Placebo combined with standard therapy DRUG

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

Megestrol Acetate Oral Suspension Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, regardless of sex
• Histologically or cytologically confirmed lung cancer
• Expected survival ≥ 3 months
• Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating

You may not qualify if:

• \. Received or scheduled to receive concurrent radiotherapy within 7 days prior to enrollment through Day 1-8 of treatment 2. Systemic corticosteroid therapy or sedating antihistamines within 7 days prior to enrollment 3. Poorly controlled serous cavity effusions (pleural/peritoneal/pericardial) 4. Severe cardiovascular diseases within 3 months prior to enrollment 5. Participation in other clinical trials within 30 days prior to enrollment

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Li Zhang, PHD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, PHD

CONTACT

+86 20-87343458; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CN (1)