SUSTOL Safety for Chemotherapy-Induced Nausea and Vomiting

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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Heron Therapeutics

Lead Sponsor

Trials

28

Recruited

6,200+