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

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Rolapitant

Granisetron

Dexamethasone

Placebo

About this trial

This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting focused on measuring Rolapitant, Nausea, Vomiting, CINV, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

TESARO Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo + Granisetron + Dexamethasone

Rolapitant

Arm Description

Day 1: Placebo + Granisetron (2 mg PO)+ Dexamethasone (20 mg PO) Days 2-3: Granisetron (2 mg PO) will be administered orally.

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.

Outcomes

Primary Outcome Measures

No Emetic Episodes and No Rescue Medication

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).

Secondary Outcome Measures

Acute Phase Response

To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.

Overall Response Rate

To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.

Full Information

NCT ID

NCT01500226

First Posted

December 22, 2011

Last Updated

February 2, 2016

Sponsor

Tesaro, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01500226

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tesaro, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Nausea and Vomiting

Keywords

Rolapitant, Nausea, Vomiting, CINV, Chemotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1369 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo + Granisetron + Dexamethasone

Arm Type

Placebo Comparator

Arm Description

Day 1: Placebo + Granisetron (2 mg PO)+ Dexamethasone (20 mg PO) Days 2-3: Granisetron (2 mg PO) will be administered orally.

Arm Title

Rolapitant

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Rolapitant

Other Intervention Name(s)

Varubi

Intervention Description

(4 X 50 mg capsule) 200 mg PO

Intervention Type

Drug

Intervention Name(s)

Granisetron

Other Intervention Name(s)

Kytril, Granisol

Intervention Description

2 mg PO

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron

Intervention Description

20 mg PO

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo to match Rolapitant

Intervention Description

(4 X 0 mg capsules) 0 mg PO

Primary Outcome Measure Information:

Title

No Emetic Episodes and No Rescue Medication

Description

Time Frame

>24 to 120 hours post chemotherapy

Secondary Outcome Measure Information:

Title

Acute Phase Response

Description

To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.

Time Frame

0 to 24 hours

Title

Overall Response Rate

Description

To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.

Time Frame

0 to 120 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis Vargo, MD

Organizational Affiliation

Tesaro, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

TESARO Inc

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02451

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26272768

Citation

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):1071-1078. doi: 10.1016/S1470-2045(15)00034-0. Epub 2015 Aug 10.

Results Reference

derived

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

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