Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Rolapitant; Granisetron; Dexamethasone; Placebo
Intervention description: (4 X 50 mg capsule) 200 mg PO; 2 mg PO; 20 mg PO; (4 X 0 mg capsules) 0 mg PO
Intervention MeSH terms: Dexamethasone; Granisetron; Rolapitant
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1369.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rolapitant; Nausea; Vomiting; CINV; Chemotherapy

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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.