Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01054456
Eligibility Criteria:
Inclusion Criteria
In order to be eligible for enrollment, subjects must meet the following inclusion criteria:
1. Provide written informed consent
2. Male or female ≥18 years of age
3. Histologically or cytologically confirmed malignant disease
4. Karnofsky Index of 50%
5. Experienced either vomiting and/or at least moderate nausea during their last cycle of LEC
6. Scheduled to receive, on Study Day 1, a single dose of one of the qualifying LEC agents listed in the protocol.
7. Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the Investigator Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
1. Inability or unwillingness to understand or cooperate with the study procedures as determined by the Investigator
2. Women who are pregnant, nursing or planning to become pregnant, women of childbearing potential who are not using an effective method of pregnancy prevention (including implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner or sexual abstinence), or women who have had a positive serum pregnancy test at screening or within 7 days prior to receiving chemo on Day 1. Non-childbearing potential includes women who are post-menopausal (12 months of amenorrhea with no other demonstrable cause, in the appropriate age group) or documented surgical sterilization, or hysterectomy at least 3 months before study start.
3. Previous use of palonosetron in association with a LEC regimen
4. Received more than one antiemetic agent for prevention of CINV (Chemotherapy-Induced Nausea and Vomiting) during their last cycle of LEC (other than dexamethasone or prednisone as outlined in number 7 below). The use of an antiemetic in addition to a corticosteroid during the last cycle of LEC is allowed if the corticosteroid is intended for the prophylactic treatment of taxane-related hypersensitivity or pemetrexed-related skin reactions as long as the corticosteroid regimen remains unchanged during the trial
5. Suspected or confirmed ongoing vomiting for any organic etiology (e.g., food poisoning, gastroenteritis, etc)
6. Received any drug with potential anti-emetic effect within 24 hours prior to the start of qualifying LEC agent
7. Scheduled to receive an antiemetic (with the exception of administration of the palonosetron) at any time during the trial, listed below
-5-HT3 receptor antagonists
* NK1 receptor antagonists
* Dopamine receptor antagonists (metoclopramide)
* Phenothiazine anti-emetics (prochlorperazine, promethazine, thiethylperazine and perphenazine)
* Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide. Diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes (e.g., paclitaxel, docetaxel) and ixabepilone
* All benzodiazepines except Triazolam or Zolpidem used once at night time due to sleep disturbances
* Atypical antipsychotic agents with compazine-like activity (e.g., olanzapine, risperidone)
* Butyrophenones (haloperidol, droperidol)
* Cannabinoides (tetrahydrocannabinol or nabilone)
* Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone), with the exception of topical or inhaled preparations. Dexamethasone will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes (e.g., paclitaxel, docetaxel) or prevention of rash associated with pemetrexed. Prednisone will be allowed if given for as part of standard regimen with mitoxantrone or docetaxel for prostate cancer.
* Any non-prescription medication, nutritional supplements, vitamins or herbal-type products known to either possibly cause nausea or vomiting, or used to treat nausea or vomiting
8. Having received any investigational drugs or devices within 30 days before study entry
9. Any vomiting, retching, or National Cancer Institute Common Terminology Criteria for Adverse Events, v.3 (NCI CTCAE) Grade 2 to 4 nausea in the 24 hours preceding chemotherapy
10. History of alcohol or drug abuse
11. Scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in this protocol
12. Any known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients
13. Scheduled to receive or have received radiotherapy within 1 week prior to or during the study
14. Any condition that, in the judgment of the Principal Investigator, would make a subject ineligible for participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01054456
Study Brief:
Protocol Section:
NCT01054456