Research study of Rolapitant versus Placebo for the prevention of nausea and vomiting related to chemotherapy that has a moderate likelihood of inducing nausea and vomiting

Phase 1

• Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Moderately Emetogenic Chemotherapy (MEC); MedDRA version: 14.1Level: LLTClassification code 10049091Term: Chemotherapy antiemetic prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022746-24-BE
• Lead Sponsor: Tesaro, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

1. Subject is 18 years of age or older, of either gender, and of any race.
2. Subject is naïve to moderately or highly emetogenic chemotherapy, and is to receive a first course of MEC including one or more of the following agents: cyclophosphamide IV (<1500 mg/m2), doxorubicin, epirubicin, carboplatin, idarubicin, ifosfamide, irinotecan, daunorubicin, cytarabine IV (>1 g/m2).
The length of each chemotherapy cycle should be no less than 2 weeks.
3. Subject has a Karnofsky performance score of =60.
4. Subject has a predicted life expectancy of = 4 months.
5. Subject has adequate bone marrow, kidney, and liver function as evidenced by:
a. Absolute neutrophil count =1500/mm3.
b. Platelet count =100,000/mm3.
c. Aspartate aminotransferase (AST) =2.5 x upper limit of normal range (ULN). For subjects with known liver metastases =5 x ULN.
d. Alanine aminotransferase (ALT) =2.5 x ULN. For subjects with known liver metastases =5 x ULN.
e. Bilirubin =1.5 x ULN, except for subjects with Gilbert‘s syndrome.
f. Creatinine =1.5 x ULN.
If a single or multiple screening laboratory test value exceeds, but is close to, the limit(s) of the reference range(s) as defined in the protocol inclusion criteria, subjects will be allowed to repeat these out-of-range tests once. If the repeated test results meet the study requirement, these subjects can be enrolled.
6. Female subjects of childbearing potential must agree to use a medically accepted method of birth control prior to Visit 1 and to continue its use during the study and for at least 30 days after the study. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, hormonal contraception, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), and surgical sterilization (e.g., vasectomy, hysterectomy or tubal ligation). Female subjects who are postmenopausal (i.e., have amenorrhea for 12 months) or surgically sterile are exempted from the use of contraception during the study.
7. Subject is able to read, understand, and complete all study-related documents.
8. Subject provides written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1080
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

Exclusion Criteria

1. Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.
2. Subject has a contraindication to the administration of prescribed MEC agent, granisetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, or systemic infection.
3. Subject is a woman of childbearing potential with a positive urine or serum pregnancy test within 3 days prior to study drug administration or is breast-feeding.
4. Subject has taken the following agents within the last 48 hours prior to the start of treatment with study drug:
a. 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.). Palonosetron is not permitted within 7 days prior to administration of investigational product.
b. Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.)
c. Benzamides (metoclopramide, alizapride, etc.)
d. Domperidone
e. Cannabinoids
f. NK1 antagonist (aprepitant)
g. Benzodiazepines (lorazepam, alprazolam, etc)
5. Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6, except on Day 1. (There is no restriction for Day 1.)
6. Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6.
7. Subject has received systemic corticosteroids or sedative antihistamines (dimenhydrinate, diphenhydramine, etc.) within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes). Subjects who are receiving inhaled steroids for respiratory conditions or topical steroids for skin disorders can be enrolled.
8. Subject has symptomatic primary or metastatic CNS disease.
9. Subject has ongoing vomiting, retching, or clinically severe nausea caused by any etiology or has a history of anticipatory nausea and vomiting.
10. Subject has vomited and/or has had dry heaves/retching within 24 hours prior to the start of MEC on Day 1 in Cycle 1.
11. Subject who has used any investigational drugs within 30 days of randomization.
12. Subject who is participating in any other clinical study.

Study & Design

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