Safety Study of Repeat Doses of SUSTOL in Adults

July 27, 2023 updated by: Heron Therapeutics

A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Hattiesburg, Mississippi, United States, 29401
        • Hattiesburg Clinic Hematology/Oncology
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Drug: SUSTOL
SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles.
Other Names:
  • Granisetron extended-release injection for subcutaneous use

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heron Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2022

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTX-100-403

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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