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Trial record 1 of 1 for:    TS-P04834
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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 study has been completed.
Information provided by (Responsible Party):
Tesaro, Inc. Identifier:
First received: December 22, 2011
Last updated: July 11, 2014
Last verified: July 2014

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.

Condition Intervention Phase
Chemotherapy-induced Nausea and Vomiting
Drug: Rolapitant
Drug: Granisetron
Drug: Dexamethasone
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Tesaro, Inc.:

Primary Outcome Measures:
  • 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).

Secondary Outcome Measures:
  • 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.

Enrollment: 1369
Study Start Date: February 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Granisetron
2 mg PO
Drug: Dexamethasone
20 mg PO
Experimental: Rolapitant
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.
Drug: Rolapitant
200 mg PO
Drug: Granisetron
2 mg PO
Drug: Dexamethasone
20 mg PO


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01500226

United States, Massachusetts
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Tesaro, Inc.
Study Director: Allen Poma, MD Tesaro, Inc.
  More Information

No publications provided

Responsible Party: Tesaro, Inc. Identifier: NCT01500226     History of Changes
Other Study ID Numbers: TS-P04834
Study First Received: December 22, 2011
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tesaro, Inc.:

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses processed this record on March 03, 2015