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Safety Study of Repeat Doses of SUSTOL in Adults

NCT05434663 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-07-28

No results posted yet for this study

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

  • Chemotherapy-Induced Nausea and Vomiting (CINV)

Interventions

DRUG

SUSTOL

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

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05434663 on ClinicalTrials.gov