Status:
COMPLETED
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
Lead Sponsor:
Tesaro, Inc.
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered prior to the initi...
Detailed Description
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered orally 1-2 hours p...
Eligibility Criteria
Inclusion
- 18 years of age or older, of either gender, and of any race
- 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).
- Karnofsky performance score of ≥60
- Predicted life expectancy of ≥4 months
- Adequate bone marrow, kidney, and liver function
Exclusion
- Contraindication to the administration of prescribed MEC agent,granisetron, or dexamethasone
- Is pregnant or breast feeding
- Has taken the following agents within the last 48 hours 5-HT3 antagonists,Phenothiazines,Benzamides,Domperidone,Cannabinoids,NK1 antagonist, Benzodiazepines
- 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
- Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6
- Has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes)
- Symptomatic primary or metastatic CNS disease.
- Has ongoing vomiting, retching, clinically significant nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
- Has vomited and/or has had dry heaves/retching within 24 hours prior to the start of MECon Day 1 in Cycle 1.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
1369 Patients enrolled
Trial Details
Trial ID
NCT01500226
Start Date
February 1 2012
End Date
February 1 2014
Last Update
March 2 2016
Active Locations (1)
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1
TESARO Inc
Waltham, Massachusetts, United States, 02451