Overview

Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tesaro, Inc.
Treatments:
8-((1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro(4,5)decan-2-one
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Emetics
Granisetron
Rolapitant
Criteria
Inclusion Criteria:

- 18 years of age or older, of either gender, and of any race

- has never been treated with cisplatin and is to receive the first course of
cisplatin-based chemotherapy (≥60 mg/m2)

- Karnofsky performance score of ≥60

- Predicted life expectancy of ≥4 months

- Adequate bone marrow, kidney, and liver function

Exclusion Criteria:

- Contraindication to cisplatin, granisetron, or dexamethasone

- Is pregnant or breast feeding

- Has previously received cisplatin or subject is planning to receive multiple days of
cisplatin in a single cycle

- 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 4
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,
pemetrexed)

- 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
cisplatin-based chemotherapy on Day 1 in Cycle 1.