Trials / Unknown
UnknownNCT05434663
Safety Study of Repeat Doses of SUSTOL in Adults
A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SUSTOL | SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles. |
Timeline
- Start date
- 2022-07-06
- Primary completion
- 2025-10-01
- Completion
- 2025-10-01
- First posted
- 2022-06-28
- Last updated
- 2023-07-28
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05434663. Inclusion in this directory is not an endorsement.