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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.
Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Study 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 at least 4 cycles of specific chemotherapy and will use SUSTOL for nausea prevention.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am not pregnant, breastfeeding, or planning to become pregnant during the study.
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I am scheduled for at least 4 cycles of specific chemotherapy and will take SUSTOL for nausea prevention.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can take standard doses of dexamethasone to prevent vomiting.
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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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%
post procedural haemorrhage
3%
dehydration
1%
migraine
1%
oral intake reduced
100%
80%
60%
40%
20%
0%
Study treatment Arm
Granisetron 20 ug/kg
Granisetron 40 ug/kg

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is SUSTOL considered to be hazardous for individuals?

"Through an internal evaluation, SUSTOL was deemed to have a safety rating of 3 due its Phase 4 classification, which denotes the regulatory approval of this medication."

Answered by AI

What is the sample size of this experiment?

"Correct. Clinicaltrials.gov provides evidence that this research project, initially posted on July 6th 2022 and recently amended on the 15th of July, is actively looking for 300 participants at a single medical centre."

Answered by AI

Is this clinical study actively seeking participants?

"Affirmative. According to the information published on clinicaltrials.gov, this medical research is actively recruiting suitable applicants since it was originally posted in June of 2022 and last updated mid-July. The study requires 300 participants who will be assessed at a singular site."

Answered by AI
~150 spots leftby Oct 2025