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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: February 2, 2016
Last verified: July 2014
Results First Received: October 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Chemotherapy-induced Nausea and Vomiting
Interventions: Drug: Rolapitant
Drug: Granisetron
Drug: Dexamethasone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rolapitant + Granisetron + Dexamethasone
  • Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy.
  • Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
  • Dexamethasone (20 mg orally) about 30 min before chemotherapy.
Placebo + Granisetron + Dexamethasone
  • Matching placebo 1–2 h before administration of chemotherapy
  • Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
  • Dexamethasone (20 mg orally) about 30 min before chemotherapy

Participant Flow:   Overall Study
    Rolapitant + Granisetron + Dexamethasone     Placebo + Granisetron + Dexamethasone  
STARTED     684 [1]   685  
COMPLETED     185 [2]   191  
NOT COMPLETED     499     494  
Adverse Event                 31                 38  
Chemo Completed or Change in Therapy                 235                 237  
Withdrawal by Subject                 93                 96  
Death                 12                 4  
Disease Progression                 16                 14  
Protocol Violation                 53                 39  
Physician Decision                 17                 15  
Lack of Efficacy                 14                 30  
Lost to Follow-up                 9                 5  
Other Reasons                 19                 16  
[1] Number of randomized patients
[2] Number of patients who completed 6 cycles



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
  • 684 subjects were randomized to Rolapitant and 685 were randomized to control;
  • 670 of those randomized to Rolapitant received study drug in C1; 674 of those who were randomized to control received study drug in C1.
  • 4 Rolapitant subject and 8 control subject were from GCP-non-compliant sites.
  • MITT = 666 Rolapitant and 666 control

Reporting Groups
  Description
Rolapitant + Granisetron + Dexamethasone
  • Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy
  • Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
  • Dexamethasone (20 mg orally) about 30 min before chemotherapy
Placebo + Granisetron + Dexamethasone
  • Matching placebo 1–2 h before administration of chemotherapy
  • Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3
  • Dexamethasone (20 mg orally) about 30 min before chemotherapy
Total Total of all reporting groups

Baseline Measures
    Rolapitant + Granisetron + Dexamethasone     Placebo + Granisetron + Dexamethasone     Total  
Number of Participants  
[units: participants]
  666     666     1332  
Age  
[units: years]
Mean (Standard Deviation)
  56.7  (11.65)     56.6  (12.01)     56.7  (11.83)  
Gender  
[units: participants]
     
Female     531     536     1067  
Male     135     130     265  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     77     70     147  
Not Hispanic or Latino     584     593     1177  
Unknown or Not Reported     5     3     8  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     7     6     13  
Asian     92     84     176  
Native Hawaiian or Other Pacific Islander     1     2     3  
Black or African American     24     29     53  
White     508     512     1020  
More than one race     0     0     0  
Unknown or Not Reported     34     33     67  



  Outcome Measures
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1.  Primary:   No Emetic Episodes and No Rescue Medication   [ Time Frame: >24 to 120 hours post chemotherapy ]

2.  Secondary:   Acute Phase Response   [ Time Frame: 0 to 24 hours ]

3.  Secondary:   Overall Response Rate   [ Time Frame: 0 to 120 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Martin Huber, M.D., Senior Vice President and Chief Medical Officer
Organization: Tesaro
phone: 781-257-2536
e-mail: mhuber@tesarobio.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT01500226     History of Changes
Other Study ID Numbers: TS-P04834
Study First Received: December 22, 2011
Results First Received: October 2, 2015
Last Updated: February 2, 2016
Health Authority: United States: Food and Drug Administration