Fosaprepitant PK/PD CINV in Pediatric Cancer Patients

Phase 1

• Conditions: Chemotherapy-induced nausea and vomiting (CINV) associated with emetogenic chemotherapy; MedDRA version: 16.1Level: LLTClassification code 10036899Term: Prophylaxis against chemotherapy induced vomitingSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002340-24-PT
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-31
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

- Patient is 0 (at least 37 weeks gestation) to 17 years of age at time of study entry (randomization).
- Parent/guardian (legally authorized representative) agrees to the
patient's participation as indicated by parent/legal guardian signature on the informed consent form. Patient 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/guardian or patient may also provide consent/assent for Future Biomedical Research. However, the patient may participate in the main trial without participating in the Future Biomedical Research.
- Patient is scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for no more than 5 consecutive days for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting.
- Female patient who has begun menses has a negative urine pregnancy test prior to randomization. A female patient who is of reproductive potential agrees to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication. Women taking oral contraception must agree to add a barrier form of contraception.
For countries where abstinence is not considered an acceptable method of birth control, a locally acceptable birth control method must be used.
- Patient has a preexisting functioning central venous catheter available for study drug administration.
- Patient's weight should not be less than the 3rd percentile for age and gender (and no less than 3.0 kg) per investigator judgment using available local growth chart(s).
Are the trial subjects under 18? yes
Number of subjects for this age range: 64
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1.
- Patient is currently a user of any illicit drugs (including marijuana) or has current evidence of alcohol abuse (defined using the Diagnostic and Statistical Manual-IV [DSM-IV] criteria) as determined by the investigator.
- Patient has received or will receive radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the course of the study.
- Patient is allergic to fosaprepitant, aprepitant, ondansetron, or any other 5-HT3 antagonist.
- Patient has an active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or a history of any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug or concomitant therapy to the patient.
- Patient is mentally incapacitated or has a significant emotional or
psychiatric disorder that, in the opinion of the investigator, precludes study entry.
- Patient has a known history of QT prolongation or is taking any
medication that is known to lead to QT prolongation.
- Patient has had benzodiazepine or opioid therapy initiated within 48 hours of study drug administration, except for single daily doses of triazolam, temazepam, or midazolam.
* Continuation of chronic benzodiazepine or opioid therapy is permitted provided it was initiated at least 48 hours prior to study drug administration.
- Patient has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of the chemotherapy regimen.

Exceptions:
• Patients who are 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, patients are 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.
- Patient is currently taking warfarin.
- Patient has ever participated in a study of aprepitant or fosaprepitant, or has taken a non-approved (investigational) drug within the last 4 weeks. Note: Patients in investigational studies with marketed chemotherapeutic agents (whether explicitly for children or only marketed for adults and usually administered to children with the appropriate dose adjustments) are allowed to enroll if they fulfill all other entry criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified