Back to resultsStudy 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 1
Locations
China
Study Type
Interventional
Intervention
HR20013 for injection；dexamethason
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 cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2)
- 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 enrollment
- Subjects who previously received NK-1 receptor antagonists within 14 days prior to enrollment
- 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 prior to the start of cisplatin
- 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HR20013 for injection+dexamethasone
Arm Description
Outcomes
Primary Outcome Measures
AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
AUC0-∞：Area Under the Plasma Concentration-time Curve From Time 0 to Infinity
Cmax：observed maximum plasma concentration
Tmax：observed time to reach Cmax
T1/2z：apparent terminal half-life
Secondary Outcome Measures
The number of participants with injection site reaction and treatment-related adverse events as assessed by CTCAE v5.0
The number of participants with injection site reaction and treatment-related adverse events as assessed by CTCAE v5.0
Complete response
No significant nausea (maximum nausea on a visual analogue scale<25 mm)
No nausea (maximum nausea on a visual analogue scale<5 mm)
No emetic
No rescue medication
Time to treatment failure
Full Information
NCT ID
NCT05465681
First Posted
July 15, 2022
Last Updated
April 11, 2023
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05465681
Brief Title
Study of HR20013 for Injection in Patients With Malignant Solid Tumors
Official Title
A Phase I Clinical Study of Safety and Pharmacokinetics of Single-dose HR20013 for Injection Combined With Dexamethasone in Patients With Malignant Solid Tumors Receiving Cisplatin-based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 13, 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 safety and pharmacokinetics of single-dose HR20013 for injection combined with dexamethasone in patients with malignant solid tumors receiving cisplatin-based 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 1
Interventional Study Model
Single Group Assignment
Model Description
HR20013 for injection combined with dexamethasone
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HR20013 for injection+dexamethasone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HR20013 for injection；dexamethason
Intervention Description
HR20013 for 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
AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
Time Frame
0 to 504 hours
Title
AUC0-∞：Area Under the Plasma Concentration-time Curve From Time 0 to Infinity
Time Frame
0 to 504 hours
Title
Cmax：observed maximum plasma concentration
Time Frame
0 to 504 hours
Title
Tmax：observed time to reach Cmax
Time Frame
0 to 504 hours
Title
T1/2z：apparent terminal half-life
Time Frame
0 to 504 hours
Secondary Outcome Measure Information:
Title
The number of participants with injection site reaction and treatment-related adverse events as assessed by CTCAE v5.0
Description
The number of participants with injection site reaction and treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
0 to 504 hours
Title
Complete response
Time Frame
During the Acute Phase [0-24 hours after the start of cisplatin administration], the Delayed (>24-120 hours) phase, the overall (0-120 hours) phase, >120-168 hours and 0-168 hours
Title
No significant nausea (maximum nausea on a visual analogue scale<25 mm)
Time Frame
During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
Title
No nausea (maximum nausea on a visual analogue scale<5 mm)
Time Frame
During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
Title
No emetic
Time Frame
During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
Title
No rescue medication
Time Frame
During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
Title
Time to treatment failure
Time Frame
During 0-168 hours
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 cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2)
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 enrollment
Subjects who previously received NK-1 receptor antagonists within 14 days prior to enrollment
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 prior to the start of cisplatin
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
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
Study of HR20013 for Injection in Patients With Malignant Solid Tumors
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