Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
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ClinicalTrials.gov Identifier: NCT01500226 |
Recruitment Status
:
Completed
First Posted
: December 28, 2011
Results First Posted
: November 4, 2015
Last Update Posted
: March 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chemotherapy-induced Nausea and Vomiting | Drug: Rolapitant Drug: Granisetron Drug: Dexamethasone Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1369 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Granisetron
2 mg PO
Other Names:
Drug: Dexamethasone
20 mg PO
Other Name: Decadron
Drug: Placebo
(4 X 0 mg capsules) 0 mg PO
Other Name: Placebo to match Rolapitant
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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.
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Drug: Rolapitant
(4 X 50 mg capsule) 200 mg PO
Other Name: Varubi
Drug: Granisetron
2 mg PO
Other Names:
Drug: Dexamethasone
20 mg PO
Other Name: Decadron
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- No Emetic Episodes and No Rescue Medication [ Time Frame: >24 to 120 hours post chemotherapy ]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).
- Acute Phase Response [ Time Frame: 0 to 24 hours ]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 ]To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500226
United States, Massachusetts | |
TESARO Inc | |
Waltham, Massachusetts, United States, 02451 |
Study Director: | Dennis Vargo, MD | Tesaro, Inc. |
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 |
First Posted: | December 28, 2011 Key Record Dates |
Results First Posted: | November 4, 2015 |
Last Update Posted: | March 2, 2016 |
Last Verified: | July 2014 |
Keywords provided by Tesaro, Inc.:
Rolapitant Nausea Vomiting CINV Chemotherapy |
Additional relevant MeSH terms:
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone acetate Dexamethasone Granisetron BB 1101 8-((1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro(4,5)decan-2-one Emetics Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Neurokinin-1 Receptor Antagonists |