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Completed

NCT Number: NCT05509634

Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors

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

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Key information

Conditions

Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center Yuexiu Campus

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HR20013 for injection；dexamethasone

Drug

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

dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy

fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone

Drug

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 outcomes

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

    Time frame: 0-120 hours 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 outcomes

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

    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

    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.

  2. 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

    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

    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.

  3. No significant nausea

    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

    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.

  4. No nausea

    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

    To compare the proportion of subjects with no nausea (defined as maximum nausea on a visual analogue scale <5 mm) during the specified period.

  5. No emetic

    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

    To compare the proportion of subjects with no emetic event during the specified period.

  6. No rescue medication

    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

    To compare the proportion of subjects who received no rescue medication during the specified period.

  7. Complete protection

    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

    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).

  8. Total control

    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

    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.

  9. Time to treatment failure

    Time frame: During 0-168 hours after the start of each cisplatin administration

    Time to the first occurrence of emetic event or the first rescue medication.

  10. The score using the functional living index-emesis (FLIE) questionnaire

    Time frame: During 0-168 hours after the start of each cisplatin administration

    To compare the change of score using FLIE questionnaire before and after treatment.

  11. 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

    To compare the number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0.

  12. plasma concentration of HR20013

    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

    To analyse the plasma concentration of HR20013 at the specified time points.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2022
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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