Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting

NCT04085393 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: UAB1950
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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)

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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)

  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)

  Day 1 through Day 6

Secondary Outcomes (5)

• Percentage of participants frequency rate of No Nausea

  Baseline

• Percentage of participants frequency rate of No Nausea

  Baseline through 24 hours

• Percentage of participants frequency rate of No Nausea

  Day 2 through Day 6

• Percentage of participants frequency rate of No Nausea

  Day 1 through Day 6

• Percentage of participants experiencing GERSC toxicity

  Baseline through 30 days

Study Arms (2)

GERSC for patients receiving highly emetogenic chemotherapy

ACTIVE COMPARATOR

Participants will receive GERSC, and two other standard antiemetics prior to chemotherapy

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

Drug: GRANISETRON EXTENDED RELEASE INJECTION (GERSC)

Interventions

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

GERSC for patients receiving highly emetogenic chemotherapy; GERSC on patients receiving moderately emetogenic chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Heron Therapeutics: collaborator

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rudolph M Navari, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professro

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 11, 2019
• Study Start: August 15, 2020
• Primary Completion: August 15, 2020
• Study Completion: December 1, 2022
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)