Phase 3
Completed N=555
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
Source: ClinicalTrials.gov NCT01500213 ↗Enrolled (actual)
555
Serious AEs
26.6%
Results posted
Nov 2015
Primary outcomePrimary: No Emetic Episodes and No Rescue Medication — 70.1; 61.9 percentage of participants — p=0.043
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 1-2 hours 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY No Emetic Episodes and No Rescue Medication |
70.1; 61.9 | 0.043 sig |
| SECONDARY Acute Phase Response |
83.4; 79.5 | 0.233 |
| SECONDARY Overall Response Rate |
67.5; 60.4 | 0.084 |
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 (NCT01500213). 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. Informational only — not medical advice.