Single Dose of MK-0517 for Prevention of CINV in Pediatric Subjects
- Conditions
- Chemotherapy-induced nausea and vomiting (CINV) associated with emetogenic chemotherapyTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001783-34-NO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
In order to be eligible for participation in this trial, the subject must, for cycle 1:
1.have parent/legal guardian (legally authorized representative) agreement to the subject’s participation as indicated by parent/legal guardian signature on the informed consent form. Subject 12 to 17 years of age, or as required by local regulation, assents and has the ability to understand the nature and intent of the study including the ability to comply with study procedures, complete study diary, and is willing to keep scheduled study visits. The parent/legal guardian or subject may also provide consent/assent for Future Biomedical Research (FBR). However, the subject may participate in the main trial without participating in the FBR.
2.be 0 (at least 37 weeks gestation) to 17 years of age at time of randomization.
3.have a Lansky Play Performance score =60 (subjects =16 years of age) or a Karnofsky score =60 (subjects >16 years of age) as defined in Section 12.4 –Lansky and Karnofsky Performance Status Scales.
4.have a predicted life expectancy =3 months.
5.be receiving chemotherapeutic agent(s) associated with moderate or high risk of emetogenicity for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting. See Section 12.5 – Emetogenicity of Commonly Used Chemotherapeutic Agents and Radiation Therapy, for guidance on the classification of chemotherapeutic agents.
Cycle 1 only: If a subject’s chemotherapy regimen has multiple chemotherapies with different emetogenic potential, then the most emetogenic agent must be part of the Day 1 regimen.
6.have a preexisting functional central venous catheter available for study drug administration.
7.Meet one of the following:
If the subject is a female who is of reproductive potential, the subject must: have a negative urine pregnancy test prior to fosaprepitant dosing in a cycle; must agree to avoid becoming pregnant in the 28 days prior to receiving study drug, while receiving study drug and for at least 30 days (or local standard of care if longer) after the last dose of study drug (including the optional cycles) by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity.
The subject is a male.
The subject is a female who is not of reproductive potential, defined as a female who either: (1) has not begun menses; (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing.
In order to be eligible for participation in an optional cycle, subject must meet inclusion criteria 5, 6 and 7 above in addition to the following:
8.have completed the preceding study cycle and related study procedures satisfactorily, have no unresolved drug related adverse events and continued participation in an optional cycle poses no unwarranted risk to the subject as determined by the investigator.
9.have parent/legal guardian (legally authorized representative) or subject (if subject is 18 years old) agreement to the subject’s
The subject must be excluded from participating in the trial if:
Exclusion criteria for Cycle 1 only:
1.has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1.
2.has a symptomatic primary or metastatic central nervous system (CNS) malignancy with nausea and/or vomiting. Subject who is asymptomatic is allowed to participate.
3.has abnormal laboratory values as follows:
•peripheral absolute neutrophil count (ANC) <1000/mm3
•platelet count <75,000/mm3
•aspartate aminotransferase (AST) >5.0 x upper limit of normal (ULN) for age
•alanine aminotransferase (ALT) >5.0 x ULN for age
•bilirubin >1.5 x ULN for age
•creatinine >1.5 x ULN for age
4.will be receiving stem cell rescue therapy in conjunction with study related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant/placebo for fosaprepitant.
5.has received or will receive total body irradiation or radiation therapy to the abdomen (includes the level of the diaphragm and below) or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period (120 hours following initiation of chemotherapy).
6.has had benzodiazepine (potential to alleviate nausea and vomiting), opioid or opioid like (e.g., tramadol hydrochloride) therapy (potential to enhance nausea and vomiting) initiated within 48 hours prior to study drug administration, or is expected to receive within 120 hours following initiation of chemotherapy, except for single daily doses of midazolam, temazepam or triazolam. Continuation of chronic benzodiazepine, opioid or opioid like therapy is permitted provided it was initiated at least 48 hours prior to study drug administration.
7.has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of the chemotherapy regimen.
Exceptions:
subject who is receiving chronic (>72 hours), daily steroid therapy can be enrolled provided the steroid dose is not >0.14 mg/kg (up to 10 mg) of prednisone daily or equivalent.
for supportive care, subject is permitted to receive a single dose of corticosteroid within 3 days prior (but not on the day of study drug administration) provided it is less than the equivalent of 20 mg of prednisone.
8.is currently taking, or has taken within 48 hours of Treatment Day 1 the following drugs with antiemetic properties: 5-HT3 antagonists (e.g., ondansetron), benzamides (e.g., metoclopramide), butyrophenones (e.g., haloperidol), cyclizine, domperidone, herbal therapies with potential antiemetic properties, olanzapine, phenothiazines (e.g., prochlorpenzine), scopolamine. Note: This is not an exhaustive list. The Sponsor should be consulted in individual cases where the subject is taking an antiemetic not listed above.
Exclusion criteria for Cycle 1 and optional Cycles 2 to 6:
9.is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
10.is currently a user of any recreational or illicit dr
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method