Phase 3
N=532
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
Chemotherapy-induced Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT01499849 ↗Enrolled (actual)
532
Serious AEs
17.3%
Results posted
Nov 2015
Primary outcome: Primary: No Emetic Episodes and No Rescue Medication — 72.7; 58.4 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rolapitant (Drug); Granisetron (Drug); dexamethasone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tesaro, Inc.
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY No Emetic Episodes and No Rescue Medication |
72.7; 58.4 | <0.001 sig |
| SECONDARY Acute Phase Response |
83.7; 73.7 | 0.005 sig |
| SECONDARY Overall Response Rate |
70.1; 56.5 | 0.001 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01499849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.