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Clinical Trials in China / NCT07130617
Starting soon Phase 1

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

NCT07130617 · tracked via the Priya Life Science China tracker
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd
Phase
Phase 1
Started
2025-09-29
Last updated
2025-08-19

Condition(s) studied

EfficacySafetyMegestrol AcetateAdult Subject

Investigational drug(s) / intervention(s)

Low dose of Megestrol Acetate Oral Suspension combined with standard therapy →Medium dose of Megestrol Acetate Oral Suspension combined with standard therapyHigh dose of Megestrol Acetate Oral Suspension combined with standard therapy →Megestrol Acetate Oral Suspension Placebo combined with standard therapy

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.

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.

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.

Megestrol Acetate Oral Suspension Placebo combined with standard therapy: A single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong

More Changchun GeneScience Pharmaceutical Co., Ltd. trials in China

A Study on Bioequivalence of Cabergoline Tablets in Human Body Active, not recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants Recruiting
Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors Recruiting
A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD) Recruiting
A Study (Phase 1b/2) of GS3-007a Oral Treatment in Children With Growth Hormone Deficiency (PGHD) Recruiting

Other trials for the same condition

Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial Recruiting
A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD) Recruiting
Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors Recruiting
Efficacy and Safety of AK104 Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer Recruiting
Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07130617 on ClinicalTrials.gov ↗ ← All trials in China