SUSTOL Safety for Chemotherapy-Induced Nausea and Vomiting

Not currently recruiting at 1 trial location

Overseen By Sophie Visonneau

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Heron Therapeutics

Must be taking: SUSTOL

Must not be taking: 5-HT3 antagonists

Disqualifiers: Severe renal impairment, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 cycles

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the cancer treatment SUSTOL affects daily life, focusing on reactions at the injection site. SUSTOL prevents nausea and vomiting from certain chemotherapy treatments. Participants must have cancer and plan to receive specific chemotherapy types, such as MEC or AC regimens, for at least four cycles, using SUSTOL for nausea prevention. The study targets individuals who can monitor how treatment impacts their daily activities. As a Phase 4 trial, SUSTOL has already received FDA approval and proven effective, and this research aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be able to receive standardized doses of dexamethasone for the prevention of nausea and vomiting.

What is the safety track record for SUSTOL?

Research has shown that SUSTOL is generally safe for people receiving chemotherapy. In previous studies, over 200 patients received a 10 mg dose under the skin. These studies found that patients tolerated SUSTOL well, with most side effects being mild. The most common issue was reactions at the injection site, such as redness or swelling.

The FDA has already approved SUSTOL to prevent nausea and vomiting from chemotherapy. This approval indicates a good safety record for its intended use. While no treatment is without risks, existing evidence supports the safety of SUSTOL for chemotherapy patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

SUSTOL is unique because it offers a long-acting formulation to combat chemotherapy-induced nausea and vomiting. Unlike standard treatments like ondansetron and granisetron, which require frequent dosing, SUSTOL is designed to provide extended relief with a single injection. This is made possible by its use of a novel polymer-based delivery system that slowly releases the active ingredient over time. Researchers are excited about SUSTOL because it could simplify the treatment regimen for patients and potentially improve their quality of life during chemotherapy.

What is the effectiveness track record for SUSTOL in preventing chemotherapy-induced nausea and vomiting?

Research has shown that SUSTOL, a long-acting form of granisetron, effectively prevents nausea and vomiting caused by chemotherapy. It addresses both immediate and delayed symptoms by releasing medicine slowly over at least five days, providing longer-lasting relief. Studies found that SUSTOL outperforms ondansetron, another anti-nausea drug, in controlling these symptoms. SUSTOL is approved for use due to its effectiveness in managing chemotherapy-induced nausea and vomiting. Participants in this trial will receive SUSTOL to further evaluate its safety profile. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can take standard doses of medication to prevent vomiting.

I am scheduled for chemotherapy and will use SUSTOL for nausea prevention.

I am not pregnant, breastfeeding, or planning to become pregnant during the study.

Exclusion Criteria

My kidneys are not working well (very low filtration rate).

Has hypersensitivity to granisetron, any component of SUSTOL, or any other 5-HT3 Receptor Antagonists

I have symptoms from a brain tumor or its spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SUSTOL® (granisetron) extended-release injection for prevention of chemotherapy-induced nausea and vomiting for up to 4 sequential cycles of chemotherapy

4 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SUSTOL

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Heron Therapeutics

Lead Sponsor

Trials

28

Recruited

6,200+

Citations

1.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2016/022445Orig1s000MedR.pdf

022445Orig1s000 | FDA

Sustol is proposed for prevention of acute and delayed chemotherapy-induced nausea and vomiting and is being considered for use with moderately ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.e24093

Granisetron extended-release subcutaneous injection ...

Granisetron extended-release subcutaneous injection versus palonosetron infusion for preventing chemotherapy-induced nausea and vomiting: A cost ...

3.

ir.herontx.com

ir.herontx.com/news-releases/news-release-details/heron-therapeutics-present-data-completed-phase-3-magic-study

News Release Details

SUSTOL® (granisetron) Injection, extended release is being developed for the prevention of both acute and delayed chemotherapy-induced nausea ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02106494

A Prospective, Multicenter, Study of APF530 (Granisetron) ...

The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26997579/

APF530 (granisetron injection extended-release) in a three ...

APF530, extended-release granisetron, provides sustained release for ≥5 days for acute- and delayed-phase chemotherapy-induced nausea and vomiting (CINV).

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05434663

Safety Study of Repeat Doses of SUSTOL in Adults

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 ...

7.

sustol.com

sustol.com/prescribing-information.pdf

prescribing information

The safety of a 10 mg subcutaneous dose of SUSTOL was evaluated in two double-blind, randomized, active- controlled studies, in which 210 patients (23%) ...

8.

withpower.com

withpower.com/trial/phase-4-vomiting-11-2022-e0bb7

SUSTOL Safety for Chemotherapy-Induced Nausea and ...

Trial Overview The study is testing the safety of repeated doses of SUSTOL (granisetron) injection for preventing nausea caused by chemotherapy. It's an open- ...