Adult Subject, Efficacy, Megestrol Acetate, Safety
Conditions
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
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.
Interventions
DRUGLow 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.
DRUGMedium 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.
DRUGHigh 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.
DRUGMegestrol Acetate Oral Suspension Placebo combined with standard therapy
A single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days.
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1\. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactLi Zhang, PHD
Outcome results
None listed