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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05434663

Enrollment

300

Registered

2022-06-28

Start date

2022-07-06

Completion date

2025-10-31

Last updated

2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-Induced Nausea and Vomiting (CINV)

Keywords

HTX-100, APF530

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).

Interventions

DRUGSUSTOL

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026