Safety Study of Repeat Doses of SUSTOL in Adults
A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy
1 other identifier
interventional
300
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2022
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedStudy Start
First participant enrolled
July 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJuly 28, 2023
July 1, 2023
3.2 years
June 22, 2022
July 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.
14 days
Study Arms (1)
Treatment Group
EXPERIMENTALInterventions
SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 29401, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 28, 2022
Study Start
July 6, 2022
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
July 28, 2023
Record last verified: 2023-07