Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)

EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting

Sponsors

Lead Sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
Brief Summary

This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting (CIV) in participants who experienced CIV in the first cycle of moderately emetic chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching in at least 20% of participants during the second cycle of MEC in participants who previously experienced vomiting during the first cycle of MEC.

Overall Status Terminated
Start Date October 25, 2011
Completion Date December 6, 2013
Primary Completion Date December 6, 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Up to 120 hours following initiation of chemotherapy in Cycle 2
Secondary Outcome
Measure Time Frame
Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy Up to 120 hours following initiation of chemotherapy in Cycle 2
Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy Up to 120 hours following initiation of chemotherapy in Cycle 2
Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy From Day 1 (prior to initiation of chemotherapy in Cycle 2) to morning of Day 6 (up to ~120 hours following initiation of chemotherapy in Cycle 2)
Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy From 24 to 120 hours following initiation of chemotherapy in Cycle 2
Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy Up to 120 hours following initiation of chemotherapy in Cycle 2
Enrollment 111
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fosaprepitant dimeglumine

Description: Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2

Arm Group Label: Fosaprepitant 150 mg

Other Name: MK-0517, EMEND® IV

Intervention Type: Drug

Intervention Name: 5-HT3 RA

Description: 5-HT3 RA will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.

Arm Group Label: Fosaprepitant 150 mg

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.

Arm Group Label: Fosaprepitant 150 mg

Intervention Type: Drug

Intervention Name: Rescue medication

Description: Rescue medication is defined as any medication used to relieve the symptoms of established nausea or vomiting. Multiple medications are permitted by the protocol and may be taken by the participant, including 5-HT3 antagonists, phenothiazines and benzodiazepines.

Arm Group Label: Fosaprepitant 150 mg

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosed with either breast or gynecological cancer

- Receiving either AC-like or CT MEC

- Experienced at least 1 episode of vomiting or retching during the first 5 days following Cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing aprepitant or fosaprepitant

- No change in chemotherapy at Cycle 2

- No change in Cycle 1 antiemetic regimen at Cycle 2

- Eastern Cooperative Oncology Group (ECOG) status 0-1

Exclusion Criteria:

- Requires increase in systemic corticosteroid therapy

- Used benzodiazepines or opiates in the 48 hours prior to Cycle 2 chemotherapy

- Received or will receive radiation therapy to the abdomen or pelvis in the week prior to Visit 1 or in Days 1-6 following chemotherapy

- Vomited in the 24 hours prior to Treatment Day 1

- Pregnant or breast-feeding

- Participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks

- Symptomatic central nervous system metastasis

- History of other malignancies in the last 2 years

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Medical Director Study Director Merck Sharp & Dohme Corp.
Verification Date

July 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Fosaprepitant 150 mg

Type: Experimental

Description: Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy

Acronym EVADE
Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov