Back to resultsSafety Study of Repeat Doses of SUSTOL in Adults
Primary Purpose
Chemotherapy-Induced Nausea and Vomiting (CINV)
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SUSTOL
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-Induced Nausea and Vomiting (CINV) focused on measuring HTX-100, APF530
Eligibility Criteria
Inclusion Criteria:
- 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.
- Has life expectancy of greater than 6 months.
- Able to receive standardized doses of dexamethasone for the prevention of emesis.
- Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.
Exclusion Criteria:
- Has hypersensitivity to granisetron, any component of SUSTOL, or any other 5-HT3 Receptor Antagonists.
- Severe renal impairment (creatinine clearance [CLcr] <30 mL/min).
- Symptomatic primary or metastatic central nervous system (CNS) disease.
- Has participated in an interventional clinical study within 30 days of Cycle 1 Day 1.
- Investigator assessment that subject would not be a good fit for the trial.
Sites / Locations
- Hattiesburg Clinic Hematology/Oncology
- Gabrail Cancer Center Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Outcomes
Primary Outcome Measures
Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05434663
Brief Title
Safety Study of Repeat Doses of SUSTOL in Adults
Official Title
A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heron Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Nausea and Vomiting (CINV)
Keywords
HTX-100, APF530
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SUSTOL
Other Intervention Name(s)
Granisetron extended-release injection for subcutaneous use
Intervention Description
SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles.
Primary Outcome Measure Information:
Title
Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Has life expectancy of greater than 6 months.
Able to receive standardized doses of dexamethasone for the prevention of emesis.
Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.
Exclusion Criteria:
Has hypersensitivity to granisetron, any component of SUSTOL, or any other 5-HT3 Receptor Antagonists.
Severe renal impairment (creatinine clearance [CLcr] <30 mL/min).
Symptomatic primary or metastatic central nervous system (CNS) disease.
Has participated in an interventional clinical study within 30 days of Cycle 1 Day 1.
Investigator assessment that subject would not be a good fit for the trial.
Facility Information:
Facility Name
Hattiesburg Clinic Hematology/Oncology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
29401
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Repeat Doses of SUSTOL in Adults
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