Safety Study of Repeat Doses of SUSTOL in Adults

Phase 4

Active, not recruiting

• Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)
• Interventions: Drug: SUSTOL

• Registration Number: NCT05434663
• Lead Sponsor: Heron Therapeutics

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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-28
• Study Start: 2022-07-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	SUSTOL	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.	14 days

Trial Locations

Locations (2)

Gabrail Cancer Center Research; 🇺🇸 Canton, Ohio, United States

Hattiesburg Clinic Hematology/Oncology; 🇺🇸 Hattiesburg, Mississippi, United States