Safety Study of Repeat Doses of SUSTOL in Adults

Chemotherapy-Induced Nausea and Vomiting (CINV) Clinical Trial

Official title:

A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05434663
• Other study ID #: HTX-100-403
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 6, 2022
• Est. completion date: October 2025

Study information

• Verified date: July 2023
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a repeat-dose, single-arm, open-label study that will evaluate the potential impact of subject-reported injection-site reactions (ISRs) on activities of daily living (ADL) in adult subjects with cancer receiving SUSTOL® (granisetron) extended-release injection, for subcutaneous use for prevention of chemotherapy induced nausea and vomiting (CINV) for up to 4 sequential cycles of chemotherapy (Moderately Emetogenic Chemotherapy [MEC] or Anthracycline and Cyclophosphamide [AC] combination regimen).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Has cancer and is scheduled to receive MEC or AC regimen for at least 4 cycles of chemotherapy, and is prescribed SUSTOL for CINV prevention.

2. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.

3. Has life expectancy of greater than 6 months.

4. Able to receive standardized doses of dexamethasone for the prevention of emesis.

5. Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.

Exclusion Criteria:

1. Has hypersensitivity to granisetron, any component of SUSTOL, or any other 5-HT3 Receptor Antagonists.

2. Severe renal impairment (creatinine clearance [CLcr] <30 mL/min).

3. Symptomatic primary or metastatic central nervous system (CNS) disease.

4. Has participated in an interventional clinical study within 30 days of Cycle 1 Day 1.

5. Investigator assessment that subject would not be a good fit for the trial.

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting (CINV)
• Vomiting

Intervention

Drug:
• SUSTOL
SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles.

Locations

Country	Name	City	State
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Hattiesburg Clinic Hematology/Oncology	Hattiesburg	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.		14 days