Safety Study of Repeat Doses of SUSTOL in Adults

NCT ID: NCT05434663

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-06

Study Completion Date

2025-10-31

Brief Summary

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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 SUSTOLĀ® (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).

Detailed Description

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Conditions

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Chemotherapy-Induced Nausea and Vomiting (CINV)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment Group

Group Type EXPERIMENTAL

SUSTOL

Intervention Type DRUG

SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles.

Interventions

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SUSTOL

SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles.

Intervention Type DRUG

Other Intervention Names

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Granisetron extended-release injection for subcutaneous use

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heron Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, United States

Site Status

Gabrail Cancer Center Research

Canton, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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HTX-100-403

Identifier Type: -

Identifier Source: org_study_id

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