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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Not yet enrolling; Phase 1

Conditions: Megestrol Acetate; Efficacy; Adult Subject; Safety

Treatments: Drug: High dose of Megestrol Acetate Oral Suspension combined with standard therapy; Drug: Megestrol Acetate Oral Suspension Placebo combined with standard therapy; Drug: Low dose of Megestrol Acetate Oral Suspension combined with standard therapy; Drug: Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07130617

GenSci158-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Age ≥ 18 years, regardless of sex

2. Histologically or cytologically confirmed lung cancer

3. Expected survival ≥ 3 months

4. Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating

5. Capable of comprehending and willingly providing signed informed consent form (ICF), and adhering to study requirements/restrictions Exclusion Criteria

6. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups

Low dose of Megestrol Acetate Oral Suspension

Experimental group

Treatment:

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

Medium dose of Megestrol Acetate Oral Suspension

Experimental group

Treatment:

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

High dose of Megestrol Acetate Oral Suspension

Experimental group

Treatment:

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

Megestrol Acetate Oral Suspension Placebo

Active Comparator group

Treatment:

Drug: Megestrol Acetate Oral Suspension Placebo combined with standard therapy