A Safety and Efficacy Study of Rolapitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Moderately Emetogenic Chemotherapy (MEC)
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 initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and the 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 the MEC administration through Day 6 in 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 examination, 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.
Chemotherapy-induced Nausea and Vomiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||A Phase 3, Multicenter, Randomized, Double Blind, Active-Controlled Study of the Safety and Efficacy of Rolapitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Moderately Emetogenic Chemotherapy|
- No Emetic Episodes and No Rescue Medication [ Time Frame: >24 to 120 hours post chemotherapy ] [ Designated as safety issue: No ]The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (>24 to 120 hours).
- Acute Phase Response [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.
- Overall Response Rate [ Time Frame: 0 to 120 hours ] [ Designated as safety issue: No ]To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.
- Safety and Tolerability [ Time Frame: 30 days post study drug ] [ Designated as safety issue: No ]To evaluate the safety and tolerability of rolapitant in subjects receiving HEC as assessed by the incidence and severity of AEs.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo + Granisetron + Dexamethasone
Day 1: Placebo + Granisetron (2 mg PO)+ Dexamethasone (20 mg PO) Days 2-3: Granisetron (2 mg PO) will be administered orally.
2 mg PODrug: Dexamethasone
20 mg PO
Day 1: Rolapitant (200 mg PO) + Granisetron (2 mg PO)+ Dexamethasone (20 mg PO) Days 2-3: Granisetron (2 mg PO) will be administered orally.
200 mg PODrug: Granisetron
2 mg PODrug: Dexamethasone
20 mg PO
|Contact: Rupal Kalapanda, PMP||781.325.1114||Rkalapanda@tesarobio.com|
|United States, Massachusetts|
|Waltham, Massachusetts, United States, 02451|
|Study Director:||Allen Poma, MD||Tesaro, Inc.|