Prevention of Nausea and Vomiting Caused by Highly Emetogenic ChemotherapyPhase 1NCT05465681
Study of HR20013 for Injection in Patients With Malignant Solid Tumors
A Phase 1 study testing HR20013 for injection；dexamethason in people with Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
- What is being tested?
- HR20013 for injection；dexamethason
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2022to 13 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- HR20013 for injection；dexamethason
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR20013 for injection；dexamethasonDrug
HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy.
dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| HR20013 for injection+dexamethasone | Experimental | Not described Receives: Drug: HR20013 for injection；dexamethason |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
Measured: 0 to 504 hours
AUC0-∞：Area Under the Plasma Concentration-time Curve From Time 0 to Infinity
Measured: 0 to 504 hours
Cmax：observed maximum plasma concentration
Measured: 0 to 504 hours
Tmax：observed time to reach Cmax
Measured: 0 to 504 hours
T1/2z：apparent terminal half-life
Measured: 0 to 504 hours
Secondary outcomes (7)
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
Measured: 0 to 504 hours
Complete response
Measured: 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
No significant nausea (maximum nausea on a visual analogue scale<25 mm)
Measured: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
No nausea (maximum nausea on a visual analogue scale<5 mm)
Measured: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
No emetic
Measured: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
No rescue medication
Measured: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
Time to treatment failure
Measured: During 0-168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start30 Aug 2022
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of Nausea and Vomiting Caused by Highly Emetogenic ChemotherapyStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HR20013 for injection combined with dexamethasone
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465681
- Sponsor's protocol ID
- HR20013-102
- Status last verified
- Jun 2022
- First submitted
- 15 Jul 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao Y, Ma Y, Yin T, Qin Z, Liu L, Kong G, Zhang R, Huang Y, Zhang L, Zhao H. Pharmacokinetics, safety, and efficacy of mixed formulation of fosrolapitant and palonosetron (HR20013) in combination with dexamethasone in patients with solid tumors scheduled for highly emetogenic cisplatin-based chemotherapy: a phase I trial. BMC Med. 2025 Aug 27;23(1):501. doi: 10.1186/s12916-025-04314-5.
PubMed 40866861
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05465681
- Acronym / sponsor ID
- HR20013-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HR20013 for injection combined with dexamethasone
| Arm | Type | Receives |
|---|---|---|
| HR20013 for injection+dexamethasone | Experimental | Drug: HR20013 for injection；dexamethason |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR20013 for injection；dexamethasonHR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy. dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy | Drug | HR20013 for injection+dexamethasone |
Primary outcome
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
AUC0-∞：Area Under the Plasma Concentration-time Curve From Time 0 to Infinity
Time frame: 0 to 504 hours
Cmax：observed maximum plasma concentration
Time frame: 0 to 504 hours
Tmax：observed time to reach Cmax
Time frame: 0 to 504 hours
T1/2z：apparent terminal half-life
Time frame: 0 to 504 hours
7 secondary outcomes
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
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
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
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
No emetic
Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
No rescue medication
Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
Time to treatment failure
Time frame: During 0-168 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 40866861Zhao Y, Ma Y, Yin T, Qin Z, Liu L, Kong G, Zhang R, Huang Y, Zhang L, Zhao H. Pharmacokinetics, safety, and efficacy of mixed formulation of fosrolapitant and palonosetron (HR20013) in combination with dexamethasone in patients with solid tumors scheduled for highly emetogenic cisplatin-based chemotherapy: a phase I trial. BMC Med. 2025 Aug 27;23(1):501. doi: 10.1186/s12916-025-04314-5.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HR20013 for injection；dexamethason in people with Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05465681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.