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

NCT01405924 | Terminated Phase 2 Results

• 1 other identifier: 0517-030
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy

  A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following chemotherapy in Cycle 2 was calculated.

  Up to 120 hours following initiation of chemotherapy in Cycle 2

Secondary Outcomes (5)

• 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

Study Arms (1)

Fosaprepitant 150 mg

EXPERIMENTAL

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

Drug: Fosaprepitant dimeglumine; Drug: 5-HT3 RA; Drug: Dexamethasone; Drug: Rescue medication

Interventions

Fosaprepitant dimeglumine DRUG

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

Also known as: MK-0517, EMEND® IV

Fosaprepitant 150 mg

5-HT3 RA DRUG

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.

Fosaprepitant 150 mg

Dexamethasone DRUG

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

Fosaprepitant 150 mg

Rescue medication DRUG

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.

Fosaprepitant 150 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

fosaprepitant; Aprepitant; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: October 25, 2011
• Primary Completion: December 6, 2013
• Study Completion: December 6, 2013
• Last Updated: August 27, 2018
• Results First Posted: October 29, 2014

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share