Chemotherapy-Induced Nausea and Vomiting (CINV)Phase 4NCT05434663
Safety Study of Repeat Doses of SUSTOL in Adults
A Phase 4 study testing SUSTOL in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Heron Therapeutics at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting (CINV)
- What is being tested?
- SUSTOL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2022to Oct 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 29401
About this study
Official title: A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy
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).
- Being tested
- SUSTOL
- Keywords
- HTX-100, APF530
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUSTOLDrug
Also called Granisetron extended-release injection for subcutaneous use
SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Drug: SUSTOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start6 Jul 2022
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Nausea and Vomiting (CINV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heron Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434663
- Sponsor's protocol ID
- HTX-100-403
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT05434663
- Acronym / sponsor ID
- HTX-100-403
- Keywords
- HTX-100, APF530
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: SUSTOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUSTOLAlso: Granisetron extended-release injection for subcutaneous useSUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles. | Drug | Treatment Group |
Primary outcome
Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SUSTOL in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Heron Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.