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5-HT3 Receptor Antagonist

SUSTOL Safety for Chemotherapy-Induced Nausea and Vomiting

Phase 4
Waitlist Available
Research Sponsored by Heron Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study
Must not have
Severe renal impairment (creatinine clearance [CLcr] <30 mL/min)
Symptomatic primary or metastatic central nervous system (CNS) disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights

Summary

This trial will test if a person's activities of daily living are impacted by injection-site reactions from SUSTOL®, an injection used to prevent chemotherapy-induced nausea and vomiting.

Who is the study for?
Adult cancer patients who will undergo at least 4 cycles of MEC or AC chemotherapy and use SUSTOL for nausea prevention can join. They should be in good physical condition (performance status 0 or 1), have a life expectancy over 6 months, and not be pregnant. Those with severe kidney issues, recent participation in other trials, known allergies to granisetron or similar drugs, or symptomatic brain disease cannot participate.Check my eligibility
What is being tested?
The study is testing the safety of repeated doses of SUSTOL (granisetron) injection for preventing nausea caused by chemotherapy. It's an open-label trial where all participants receive the drug during up to four chemo cycles while monitoring its effects on their daily activities.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site that may affect daily activities. Since it's designed to prevent nausea and vomiting from chemotherapy, there might also be general side effects related to granisetron such as headaches or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for chemotherapy and will use SUSTOL for nausea prevention.
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I am not pregnant, breastfeeding, or planning to become pregnant during the study.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidneys are not working well (very low filtration rate).
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I have symptoms from a brain tumor or its spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.

Side effects data

From 2007 Phase 4 trial • 171 Patients • NCT00231478
8%
vomiting
3%
dehydration
3%
post procedural haemorrhage
1%
oral intake reduced
1%
migraine
100%
80%
60%
40%
20%
0%
Study treatment Arm
Granisetron 20 ug/kg
Granisetron 40 ug/kg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Heron TherapeuticsLead Sponsor
27 Previous Clinical Trials
5,886 Total Patients Enrolled
1 Trials studying Nausea and Vomiting
1,428 Patients Enrolled for Nausea and Vomiting

Media Library

SUSTOL (5-HT3 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05434663 — Phase 4
Nausea and Vomiting Research Study Groups: Treatment Group
Nausea and Vomiting Clinical Trial 2023: SUSTOL Highlights & Side Effects. Trial Name: NCT05434663 — Phase 4
SUSTOL (5-HT3 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05434663 — Phase 4
~111 spots leftby Oct 2025
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