Nausea With Vomiting Chemotherapy-Induced
Conditions
Brief summary
Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.
Detailed description
This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.
Interventions
DRUGPalonosetron Hydrochloride Buccal Film 0.25 Mg
Dose equal to the iv control
DRUGPalonosetron Hydrochloride Buccal Film 0.5 Mg
Dose twice that of iv control
DRUGPalonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
iv control
Sponsors
Xiamen LP Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* With histologically or cytologically confirmed malignant disease; -. Be scheduled to receive the first course of MEC to be administered on Day 1 * Using reliable contraceptive measures; * negative serum pregnancy test (if potentially child bearing)
Exclusion criteria
* Received investigational drugs within 30 days before the start of study treatment or scheduled to receive a highly or moderately emetogenic chemotherapeutic agent; * Have a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication; * Have severe renal or hepatic impairment; * Have positive serology test results; * Have a known contraindication to 5-HT3 receptor antagonists; * Treated with commercially available or investigative palonosetron formulation within 2 weeks prior to start of study treatment; * Allergic to palonosetron or any other 5-HT3 antagonist; * Currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence as determined by the investigator; * Will be receiving stem cell rescue therapy in conjunction with study related course of emetogenic chemotherapy; * Received or will receive total body irradiation or radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Acute Response | first 24 hours after chemotherapy | no emetic episode and no rescue medication during the first 24 hours after chemotherapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A (Buccal 0.25 Mg) Palonosetron HCl Buccal Film 0.25 Mg | 7 |
| B (Buccal 0.5 Mg) Palonosetron HCl Buccal Film 0.5 Mg | 8 |
| C (IV Injection 0.25 Mg) IV palonosetron 0.25 Mg (ALOXI®) | 6 |
| Total | 21 |
Baseline characteristics
| Characteristic | Total | A (Buccal 0.25 Mg) | B (Buccal 0.5 Mg) | C (IV Injection 0.25 Mg) |
|---|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 10.32 | 63.4 years STANDARD_DEVIATION 9.32 | 53.9 years STANDARD_DEVIATION 10.96 | 59.8 years STANDARD_DEVIATION 9.13 |
| History of motion sickness No | 17 participants | 6 participants | 6 participants | 5 participants |
| History of motion sickness Yes | 4 participants | 1 participants | 2 participants | 1 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 5 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Female | 16 Participants | 5 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 3 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 | 0 / 6 |
Outcome results
Primary
Complete Acute Response
no emetic episode and no rescue medication during the first 24 hours after chemotherapy
Time frame: first 24 hours after chemotherapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A (Buccal 0.25 Mg) | Complete Acute Response | 4 Participants |
| B (Buccal 0.50 Mg) | Complete Acute Response | 4 Participants |
| C (IV Injection 0.25 Mg) | Complete Acute Response | 3 Participants |