CompletedPhase 1

Study of HR20013 for Injection in Patients With Malignant Solid Tumors

China24 participantsStarted 2022-08-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration

Timeframe: 0 to 504 hours

AUC0-∞：Area Under the Plasma Concentration-time Curve From Time 0 to Infinity

Timeframe: 0 to 504 hours

Cmax：observed maximum plasma concentration

Timeframe: 0 to 504 hours

Tmax：observed time to reach Cmax

Timeframe: 0 to 504 hours

T1/2z：apparent terminal half-life

Timeframe: 0 to 504 hours

Trial details

NCT IDNCT05465681

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-13

View on ClinicalTrials.gov More Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration

Timeframe: 0 to 504 hours

AUC0-∞：Area Under the Plasma Concentration-time Curve From Time 0 to Infinity

Timeframe: 0 to 504 hours

Cmax：observed maximum plasma concentration

Timeframe: 0 to 504 hours

Tmax：observed time to reach Cmax

Timeframe: 0 to 504 hours

T1/2z：apparent terminal half-life

Timeframe: 0 to 504 hours