Chemotherapy-induced Nausea and VomitingPhase 2NCT04085393
Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting
A Phase 2 study testing GRANISETRON EXTENDED RELEASE INJECTION (GERSC) in people with Chemotherapy-induced Nausea and Vomiting, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific patient characteristics such as female gender, age, and history of low alcohol intake can increase a patients' risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- GRANISETRON EXTENDED RELEASE INJECTION (GERSC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2020to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnosis of malignant disease and scheduled for MEC or HEC
- Chemotherapy naive
- Age ≥18 years.
- ECOG Performance Status 0 or 1
- Required Initial Laboratory Values ≤28 days prior to registration. Patient must have adequate bone marrow, kidney, and liver function as evidenced by:
- Platelet count ≥ 100,000/ mm3
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- Bilirubin ≤ 1.5 x ULN, except for subjects with Gilbert's syndrome
- Serum Creatinine ≤2.0 mg/dL
- SGOT or SGPT ≤3 x upper limit of normal (ULN)
- Absolute neutrophil count (ANC) ≥1500/mm3
- Patients receiving HEC will have received the 5HT3 receptor antagonist palonosetron, a NK-1, and dexamethasone as antiemetic prophylaxis during cycle 1 of chemotherapy
- Patients receiving MEC will have received the 5HT3 receptor antagonist palonosetron, and dexamethasone as antiemetic prophylaxis during cycle 1 of chemotherapy
Who cannot join
- No nausea or vomiting ≤ 24 hours prior to registration.
- Negative pregnancy test (serum β hCG) done ≤7 days prior to registration, for women of childbearing potential only (per clinician discretion).
- No severe cognitive compromise.
- No known history of active, untreated CNS disease (e.g. brain metastases, seizure disorder).
- No concurrent use of amifostine, thioridazine, pimozide or St. John's wort.
- No concurrent abdominal radiotherapy.
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- No concurrent use of olanzapine therapy.
- No chronic alcoholism (as determined by the investigator).
- No known hypersensitivity to granisetron.
- No known uncontrolled cardiac arrhythmia or uncontrolled congestive heart failure.
- No acute myocardial infarction within the previous six months.
- No history of uncontrolled diabetes mellitus (may be on a stable dose of insulin or on a stable dose of an oral hypoglycemic agent).
- Patients with psychiatric illness that would prevent the patient from giving informed consent are not eligible for the trial
- Medical condition such as uncontrolled infection (including HIV),uncontrolled Diabetes Mellitus, unstable cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient are not eligible for the trial
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible for the trial; Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
- Patients who cannot swallow oral formulations of the agent(s) are not eligible for the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Breakthrough Nausea and Vomiting (CINV) in Patients Receiving Moderately or Highly Emetogenic Chemotherapy: A Phase II Clinical Trial
Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific patient characteristics such as female gender, age, and history of low alcohol intake can increase a patients' risk for CINV.
GERSC is a new, subcutaneously (SC) administered polymeric formulation of Granisetron that was developed to provide slow, controlled, and sustained release of Granisetron to prevent both acute and delayed CINV associated with moderately emetic chemotherapy (MEC) and highly emetic chemotherapy (HEC)
Read the detailed description
All patients eligible for the study receiving moderately emetogenic (MEC) chemotherapy will receive GERSC receptor antagonist on day one. All patients eligible for the study receiving highly emetogenic Chemotherapy (HEC) chemotherapy will receive GERSC receptor antagonist on day one including dexamethasone and NK-1 Receptor antagonist during cycle 1.
The primary objective is to measure the Complete Response (no emetic episodes, no use of rescue medications) in patients receiving GERSC as a replacement for the second generation 5 HT3 receptor antagonist palonosetron used in the first chemotherapy cycle for those patients receiving MEC or HEC and developed Breakthrough CINV. Complete response would be recorded specifically for the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy), and overall periods (0-120 hours post-chemotherapy).
This study has two study groups.
- Group 1 (HEC) will receive GERSC, dexamethasone and NK-1 antagonist prior to chemotherapy
- Group 2 (MEC) will receive GERSC and dexamethasone prior to chemotherapy
During the study:
Participants will be completing questionnaires on day 1 prior to treatment and at approximately the same time treatment was given each day for the next seven days. Participant will be assessed each day on the amount of nausea, vomiting, and/or sedation experienced in the previous 24-hour period. The assessment should take less than 5 minutes to complete each day.
Participants will be registered for Quality of Life measurement. Validated QOL measurements of fatigue and overall perception of QOL will be assessed upon registration in this study. Fatigue and overall well-being clearly can impact how well patients will do in terms of being able to tolerate and experience nausea and vomiting
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- GRANISETRON EXTENDED RELEASE INJECTION (GERSC)
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRANISETRON EXTENDED RELEASE INJECTION (GERSC)Drug
GERSC is a new, subcutaneously (SC) administered polymeric formulation of granisetron that was developed to provide slow, controlled, and sustained release of granisetron to prevent both acute and delayed CINV associated with MEC and HEC. Due to the prolonged efficacy, GERSC may potentially improve CINV in the acute and delayed periods and the single dose regimen may improve patient adherence to antiemetic therapy
| Study group | Role | What they receive |
|---|---|---|
| GERSC for patients receiving highly emetogenic chemotherapy | Active comparator | Participants will receive GERSC, and two other standard antiemetics prior to chemotherapy Receives: Drug: GRANISETRON EXTENDED RELEASE INJECTION (GERSC) |
| GERSC on patients receiving moderately emetogenic chemotherapy | Active comparator | Participants will receive GERSC and one other standard antiemetic prior to chemotherapy Receives: Drug: GRANISETRON EXTENDED RELEASE INJECTION (GERSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a previous history of emetic episodes
After participants have completed their informed consent, they will complete a baseline assessment to record emetic episodes prior to chemotherapy.
Measured: Baseline assessment
Percentage of participants with a complete response of no emetic episode
Patient will be monitored for vomiting on Day 1 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
Measured: Baseline through 24 hours
Percentage of participants with a complete response of no emetic episode
Patient will be monitored for vomiting on Day 2 through Day 6 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
Measured: Day 2 through Day 6
Percentage of participants with a complete response of no emetic episode
Patient will be monitored for total vomiting episodes starting from Day 1 through Day 6 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
Measured: Day 1 through Day 6
Secondary outcomes (5)
Percentage of participants frequency rate of No Nausea
Participants will complete a Visual Analogue Scale at baseline to record their history of the presence or absence of nausea and frequency prior to chemotherapy. The scale range is between 0 - 10 (0 = No Nausea; 10 = Excessive Nausea).
Measured: Baseline
Percentage of participants frequency rate of No Nausea
Participants will complete a Visual Analogue Scale on Day 1 to record the presence or absence of nausea and frequency after receiving chemotherapy. The scale range is between 0 - 10 (0 = No Nausea; 10 = Excessive Nausea).
Measured: Baseline through 24 hours
Percentage of participants frequency rate of No Nausea
Participants will complete a Visual Analogue Scale on Day 2 through Day 6 to record the presence or absence of nausea and frequency after receiving chemotherapy. The scale range is between 0 - 10 (0 = No Nausea; 10 = Excessive Nausea).
Measured: Day 2 through Day 6
Percentage of participants frequency rate of No Nausea
Participants will complete a Visual Analogue Scale on Day 1 through Day 6 to record the presence or absence of nausea and frequency after receiving chemotherapy. The scale range is between 0 - 10 (0 = No Nausea; 10 = Excessive Nausea).
Measured: Day 1 through Day 6
Percentage of participants experiencing GERSC toxicity
The toxicity will be assessed by the severity of the side effects listed below. The descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 will be utilized for reporting.
- Constipation
- Fatigue
- Headache
- Diarrhea
- Abdominal Pain
- Sleeplessness (Insomnia)
- Indigestion (Dyspepsia)
- Dizziness
- Asthenia
- Gastroesophageal Reflux
Measured: Baseline through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start15 Aug 2020
- Primary completion15 Aug 2020
- Study completion1 Dec 2022 (estimated)
Why it stopped: sponsor withdrew study
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 VomitingStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Heron Therapeutics
- Responsible party
- Principal investigator, Rudolph Navari, University of Alabama at Birmingham
- Investigators
- Rudolph M Navari, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085393
- Sponsor's protocol ID
- UAB1950
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2019
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Breakthrough Nausea and Vomiting (CINV) in Patients Receiving Moderately or Highly Emetogenic Chemotherapy: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04085393
- Acronym / sponsor ID
- UAB1950
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor withdrew study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Heron Therapeutics
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 11 Sep 2019 (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.
Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific patient characteristics such as female gender, age, and history of low alcohol intake can increase a patients' risk for CINV.
GERSC is a new, subcutaneously (SC) administered polymeric formulation of Granisetron that was developed to provide slow, controlled, and sustained release of Granisetron to prevent both acute and delayed CINV associated with moderately emetic chemotherapy (MEC) and highly emetic chemotherapy (HEC)
Detailed description
All patients eligible for the study receiving moderately emetogenic (MEC) chemotherapy will receive GERSC receptor antagonist on day one. All patients eligible for the study receiving highly emetogenic Chemotherapy (HEC) chemotherapy will receive GERSC receptor antagonist on day one including dexamethasone and NK-1 Receptor antagonist during cycle 1.
The primary objective is to measure the Complete Response (no emetic episodes, no use of rescue medications) in patients receiving GERSC as a replacement for the second generation 5 HT3 receptor antagonist palonosetron used in the first chemotherapy cycle for those patients receiving MEC or HEC and developed Breakthrough CINV. Complete response would be recorded specifically for the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy), and overall periods (0-120 hours post-chemotherapy).
This study has two study groups.
- Group 1 (HEC) will receive GERSC, dexamethasone and NK-1 antagonist prior to chemotherapy
- Group 2 (MEC) will receive GERSC and dexamethasone prior to chemotherapy
During the study:
Participants will be completing questionnaires on day 1 prior to treatment and at approximately the same time treatment was given each day for the next seven days. Participant will be assessed each day on the amount of nausea, vomiting, and/or sedation experienced in the previous 24-hour period. The assessment should take less than 5 minutes to complete each day.
Participants will be registered for Quality of Life measurement. Validated QOL measurements of fatigue and overall perception of QOL will be assessed upon registration in this study. Fatigue and overall well-being clearly can impact how well patients will do in terms of being able to tolerate and experience nausea and vomiting
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GERSC for patients receiving highly emetogenic chemotherapy | Active comparator | Drug: GRANISETRON EXTENDED RELEASE INJECTION (GERSC)Participants will receive GERSC, and two other standard antiemetics prior to chemotherapy |
| GERSC on patients receiving moderately emetogenic chemotherapy | Active comparator | Drug: GRANISETRON EXTENDED RELEASE INJECTION (GERSC)Participants will receive GERSC and one other standard antiemetic prior to chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of malignant disease and scheduled for MEC or HEC
- Chemotherapy naive
- Age ≥18 years.
- ECOG Performance Status 0 or 1
- Required Initial Laboratory Values ≤28 days prior to registration. Patient must have adequate bone marrow, kidney, and liver function as evidenced by:
Key exclusion criteria (16 listed)
- No nausea or vomiting ≤ 24 hours prior to registration.
- Negative pregnancy test (serum β hCG) done ≤7 days prior to registration, for women of childbearing potential only (per clinician discretion).
- No severe cognitive compromise.
- No known history of active, untreated CNS disease (e.g. brain metastases, seizure disorder).
- No concurrent use of amifostine, thioridazine, pimozide or St. John's wort.
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 |
|---|---|---|
| GRANISETRON EXTENDED RELEASE INJECTION (GERSC)GERSC is a new, subcutaneously (SC) administered polymeric formulation of granisetron that was developed to provide slow, controlled, and sustained release of granisetron to prevent both acute and delayed CINV associated with MEC and HEC. Due to the prolonged efficacy, GERSC may potentially improve CINV in the acute and delayed periods and the single dose regimen may improve patient adherence to antiemetic therapy | Drug | GERSC for patients receiving highly emetogenic chemotherapy, GERSC on patients receiving moderately emetogenic chemotherapy |
Primary outcome
Percentage of participants with a previous history of emetic episodes
Time frame: Baseline assessment
After participants have completed their informed consent, they will complete a baseline assessment to record emetic episodes prior to chemotherapy.
Percentage of participants with a complete response of no emetic episode
Time frame: Baseline through 24 hours
Patient will be monitored for vomiting on Day 1 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
Percentage of participants with a complete response of no emetic episode
Time frame: Day 2 through Day 6
Patient will be monitored for vomiting on Day 2 through Day 6 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
Percentage of participants with a complete response of no emetic episode
Time frame: Day 1 through Day 6
Patient will be monitored for total vomiting episodes starting from Day 1 through Day 6 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
5 secondary outcomes
Percentage of participants frequency rate of No Nausea
Time frame: Baseline
Percentage of participants frequency rate of No Nausea
Time frame: Baseline through 24 hours
Percentage of participants frequency rate of No Nausea
Time frame: Day 2 through Day 6
Percentage of participants frequency rate of No Nausea
Time frame: Day 1 through Day 6
Percentage of participants experiencing GERSC toxicity
Time frame: Baseline through 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Rudolph M Navari, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRANISETRON EXTENDED RELEASE INJECTION (GERSC) in people with Chemotherapy-induced Nausea and Vomiting, run by University of Alabama at Birmingham at 1 site 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 12 inclusion and 16 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: withdrawn, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of participants with a previous history of emetic episodes (time frame: Baseline assessment). The study lists 4 primary outcomes in all. 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 30 Sep 2020.