Back to resultsClinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors
Primary Purpose
Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HR20013 for injection；dexamethasone
fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Sites / Locations
- Sun Yat-sen University Cancer Center Yuexiu Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group A
Treatment group B
Arm Description
HR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone
simulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Complete response during the acute phase, the delayed phase, >120-168 hours, and 0-168 hours after the start of the first cisplatin administration
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.
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
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.
No significant nausea
To compare the proportion of subjects with no significant nausea (defined as maximum nausea on a visual analogue scale <25 mm) during the specified period.
No nausea
To compare the proportion of subjects with no nausea (defined as maximum nausea on a visual analogue scale <5 mm) during the specified period.
No emetic
To compare the proportion of subjects with no emetic event during the specified period.
No rescue medication
To compare the proportion of subjects who received no rescue medication during the specified period.
Complete protection
To compare the proportion of subjects with complete protection (defined as patients who experienced no emetic event and received no rescue medication and had no significant nausea) during the specified period).
Total control
To compare the proportion of subjects with total control (defined as patients who experienced no emetic events and received no rescue medication and had no nausea) during the specified period.
Time to treatment failure
Time to the first occurrence of emetic event or the first rescue medication.
The score using the functional living index-emesis (FLIE) questionnaire
To compare the change of score using FLIE questionnaire before and after treatment.
Number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0
To compare the number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0.
plasma concentration of HR20013
To analyse the plasma concentration of HR20013 at the specified time points.
Full Information
NCT ID
NCT05509634
First Posted
August 16, 2022
Last Updated
September 12, 2023
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05509634
Brief Title
Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors
Official Title
Compared With Fosaprepitant Dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of HR20013 for Injection for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 8, 2022 (Actual)
Primary Completion Date
June 19, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
HR20013 for injection + dexamethasone compared with fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
754 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
HR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone
Arm Title
Treatment group B
Arm Type
Active Comparator
Arm Description
simulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone
Intervention Type
Drug
Intervention Name(s)
HR20013 for injection；dexamethasone
Intervention Description
HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy
dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
Intervention Type
Drug
Intervention Name(s)
fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete response during the overall phase after the start of the first cisplatin administration
Description
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.
Time Frame
0-120 hours after the start of the first cisplatin administration
Secondary Outcome Measure Information:
Title
Complete response during the acute phase, the delayed phase, >120-168 hours, and 0-168 hours after the start of the first cisplatin administration
Description
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.
Time Frame
the acute phase (0-24 hours), the delayed phase (>24-120 hours), >120-168 hours, and 0-168 hours after the first cisplatin administration
Title
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
Description
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.
Time Frame
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
Title
No significant nausea
Description
To compare the proportion of subjects with no significant nausea (defined as maximum nausea on a visual analogue scale <25 mm) during the specified period.
Time Frame
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
Title
No nausea
Description
To compare the proportion of subjects with no nausea (defined as maximum nausea on a visual analogue scale <5 mm) during the specified period.
Time Frame
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
Title
No emetic
Description
To compare the proportion of subjects with no emetic event during the specified period.
Time Frame
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
Title
No rescue medication
Description
To compare the proportion of subjects who received no rescue medication during the specified period.
Time Frame
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
Title
Complete protection
Description
To compare the proportion of subjects with complete protection (defined as patients who experienced no emetic event and received no rescue medication and had no significant nausea) during the specified period).
Time Frame
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
Title
Total control
Description
To compare the proportion of subjects with total control (defined as patients who experienced no emetic events and received no rescue medication and had no nausea) during the specified period.
Time Frame
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
Title
Time to treatment failure
Description
Time to the first occurrence of emetic event or the first rescue medication.
Time Frame
During 0-168 hours after the start of each cisplatin administration
Title
The score using the functional living index-emesis (FLIE) questionnaire
Description
To compare the change of score using FLIE questionnaire before and after treatment.
Time Frame
During 0-168 hours after the start of each cisplatin administration
Title
Number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0
Description
To compare the number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
0 to 504 hours after the start of each cisplatin administration
Title
plasma concentration of HR20013
Description
To analyse the plasma concentration of HR20013 at the specified time points.
Time Frame
Evaluation time points include 1-2 hours, 5-10 hours, and 3 days after the start of the first HR20013 administration, and day 1 of the second HR20013 administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
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
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center Yuexiu Campus
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors
We'll reach out to this number within 24 hrs