NCT05509634

Brief Summary

To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
754

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

October 27, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

August 16, 2022

Last Update Submit

October 25, 2023

Conditions

Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Complete response during the overall phase after the start of the first cisplatin administration

    To compare the rate of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) after the start of the first cisplatin administration.

    0-120 hours after the start of the first cisplatin administration

Secondary Outcomes (12)

  • Complete response during the acute phase, the delayed phase, >120-168 hours, and 0-168 hours after the start of the first cisplatin administration

    the acute phase (0-24 hours), the delayed phase (>24-120 hours), >120-168 hours, and 0-168 hours after the first cisplatin administration

  • Complete response during the acute phase, the delayed phase, the overall phase, >120-168 hours, and 0-168 hours after the start of the second cisplatin administration

    the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours, and 0-168 hours after the start of the second cisplatin administration

  • No significant nausea

    the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration

  • No nausea

    the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration

  • No emetic

    the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration

  • +7 more secondary outcomes

Study Arms (2)

Treatment group A

EXPERIMENTAL

HR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone

Drug: HR20013 for injection；dexamethasone

Treatment group B

ACTIVE COMPARATOR

simulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone

Drug: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone

Interventions

HR20013 for injection；dexamethasoneDRUG

HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy

Treatment group A
fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasoneDRUG

fosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy

Treatment group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older, of either gender
  • Has a diagnosed malignant tumor
  • has never been treated with chemotherapy and is to receive the first course of cisplatin-based chemotherapy
  • Predicted life expectancy of ≥ 3 months
  • Has a performance status (ECOG scale) of 0 to 1
  • Adequate bone marrow, kidney, and liver function
  • Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
  • Able and willing to provide a written informed consent

You may not qualify if:

  • Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 8
  • Scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from Day 2 through Day 8
  • Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines
  • Subjects receiving palonosetron hydrochloride within 14 days before randomization
  • Subjects who previously received NK-1 receptor antagonists within 28 days prior to randomization
  • Subjects with a history of myocardial infarction or unstable angina pectoris
  • Subjects with atrioventricular block or cardiac insufficiency
  • Subjects with poor blood pressure control after medication
  • Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension
  • Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours before randomization
  • Participated in clinical trials of other drugs (received experimental drugs)
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center Yuexiu Campus

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Zhou H, Zhao Y, Zhang M, Yao J, Leng S, Li X, Lin L, Chen J, Zhang S, Qin X, Qin Z, Yi T, Wang R, Li X, Yu Y, Wang Z, Zheng Q, Mei J, Zang A, Li N, Cao F, Cao K, Li W, Lu Y, Lin D, Zhou Y, Yang R, Fang W, Zhou N, Yang Y, Zhang Y, Chen G, Zhou T, Yang X, Wang H, Wang Y, Huang Y, Zhang L. Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT. J Clin Oncol. 2025 Mar 20;43(9):1123-1136. doi: 10.1200/JCO-24-01308. Epub 2024 Dec 2.

    PMID: 39621965DERIVED

MeSH Terms

Interventions

fosaprepitant

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: HR20013 for injection + dexamethasone compared with fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 22, 2022

Study Start

September 21, 2022

Primary Completion

June 19, 2023

Study Completion

August 30, 2023

Last Updated

October 27, 2023

Record last verified: 2023-09

Locations

CN(1)