Status:
UNKNOWN
Safety Study of Repeat Doses of SUSTOL in Adults
Lead Sponsor:
Heron Therapeutics
Conditions:
Chemotherapy-Induced Nausea and Vomiting (CINV)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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.
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Has life expectancy of greater than 6 months.
- Able to receive standardized doses of dexamethasone for the prevention of emesis.
- Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.
Exclusion
- Has hypersensitivity to granisetron, any component of SUSTOL, or any other 5-HT3 Receptor Antagonists.
- Severe renal impairment (creatinine clearance \[CLcr\] \<30 mL/min).
- Symptomatic primary or metastatic central nervous system (CNS) disease.
- Has participated in an interventional clinical study within 30 days of Cycle 1 Day 1.
- Investigator assessment that subject would not be a good fit for the trial.
Key Trial Info
Start Date :
July 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05434663
Start Date
July 6 2022
End Date
October 1 2025
Last Update
July 28 2023
Active Locations (2)
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1
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States, 29401
2
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718