Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tesaro, Inc.
ClinicalTrials.gov Identifier:
NCT01500226
First received: December 22, 2011
Last updated: November 10, 2015
Last verified: July 2014

December 22, 2011
November 10, 2015
February 2012
February 2014   (final data collection date for primary outcome measure)
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 emesis and no rescue medication) in the delayed phase (>24 to 120 hours).
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).
Complete list of historical versions of study NCT01500226 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
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
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.
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 orally 1-2 hours prior to the initiation of chemotherapy on Day 1. Granisetron (2 mg PO) and dexamethasone (20 mg PO) will be administered approximately 30 minutes before initiation of chemotherapy. Subjects will continue to receive granisetron (2 mg daily) on Days 2 and 3. 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 and neurological examinations, vital signs, electrocardiograms (ECGs), and safety laboratory values including BUN and creatinine. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles. Blood samples may be collected and stored in this study and may be analyzed for future biomarker research related to safety and efficacy.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Chemotherapy-induced Nausea and Vomiting
  • Drug: Rolapitant
    200 mg PO
    Other Name: Varubi
  • Drug: Granisetron
    2 mg PO
    Other Names:
    • Kytril
    • Granisol
  • Drug: Dexamethasone
    20 mg PO
    Other Name: Decadron
  • 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.
    Interventions:
    • Drug: Granisetron
    • Drug: Dexamethasone
  • 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.
    Interventions:
    • Drug: Rolapitant
    • Drug: Granisetron
    • Drug: Dexamethasone
Schwartzberg LS, Modiano MR, Rapoport BL, Chasen MR, Gridelli C, Urban L, Poma A, Arora S, Navari RM, Schnadig ID. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial. Lancet Oncol. 2015 Sep;16(9):1071-8. doi: 10.1016/S1470-2045(15)00034-0. Epub 2015 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1369
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01500226
TS-P04834
No
Not Provided
Not Provided
Tesaro, Inc.
Tesaro, Inc.
Not Provided
Study Director: Dennis Vargo, MD Tesaro, Inc.
Tesaro, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP