NCT01405924: EVADE

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

Terminated Phase 2 Results posted Last updated 27 August 2018

What this trial tests

Phase 2 trial testing Fosaprepitant dimeglumine in Nausea in 111 participants. Terminated before completion.

Timeline

25 October 2011

Primary endpoint
6 December 2013

6 December 2013

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	111
Start date	25 October 2011
Primary completion	6 December 2013
Estimated completion	6 December 2013

Drugs / interventions tested

• Fosaprepitant dimeglumine — full drug profile →
• 5-HT3 RA — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Rescue medication — full drug profile →

Conditions studied

• Nausea — all drugs for Nausea →
• Vomiting — all drugs for Vomiting →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, female only, with Nausea or Vomiting. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Primary · Up to 120 hours following initiation of chemotherapy in Cycle 2

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.

Group	Value	95% CI
Fosaprepitant 150 mg	57.43

Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy Secondary · Up to 120 hours following initiation of chemotherapy in Cycle 2

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 initiation of chemotherapy in Cycle 2 was calculated based on type of chemotherapy received.

Group	Value	95% CI
Fosaprepitant 150 mg: AC-like Chemotherapy	62.30
Fosaprepitant 150 mg: CT Chemotherapy	50.00

Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy Secondary · Up to 120 hours following initiation of chemotherapy in Cycle 2

A complete response is defined as no vomiting/no retching episodes and no use of rescue medication during the 120 hours following initiation of chemotherapy. The percentage of participants with a complete response during Cycle 2 of chemotherapy was calculated.

Group	Value	95% CI
Fosaprepitant 150 mg	21.78

Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy Secondary · 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)

The FLIE Total Score is an 18-question quality-of-life questionnaire on the impact of nausea and vomiting (9 questions on nausea and 9 questions on vomiting) on daily life. Each question uses a visual analog scale (VAS) to rate the impact of nausea/vomiting from 1 to 7. FLIE Total Scores are calculated by summing the responses to the 18 questions and can range from 18-126 (18=a great deal of impairment, 126=no impairment), with a higher score indicating less impairment due to nausea and vomiting. "No Impact" on daily life was defined as a FLIE Total Score \>108. Participants completed the FLIE

Day 1 (prior to chemotherapy)

Group	Value	95% CI
Fosaprepitant 150 mg	92.90	± 9.58

Day 6

Group	Value	95% CI
Fosaprepitant 150 mg	80.50	± 18.79

Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy Secondary · From 24 to 120 hours following initiation of chemotherapy in Cycle 2

Participants rated their degree of nausea in response to "How much nausea have you had over the last 24 hours?" using a 100-mm visual analog scale (VAS, 0=no nausea, 100=nausea as bad as it could be) on Days 2-6 following initiation of chemotherapy. No significant nausea was defined as VAS score \<25 mm over the 24-120 hours following initiation of chemotherapy. The percentage of participants who experienced no significant nausea during Cycle 2 of chemotherapy was calculated.

Group	Value	95% CI
Fosaprepitant 150 mg	47.52

Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy Secondary · Up to 120 hours following initiation of chemotherapy in Cycle 2

Participants recorded any use of rescue medication for established nausea/vomiting in their daily diaries from initiation of chemotherapy infusion through the morning of Day 6. The percentage of participants who used no rescue medication during Cycle 2 of chemotherapy was calculated.

Group	Value	95% CI
Fosaprepitant 150 mg	30.69

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 18 after study drug administration (Up to 18 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fosaprepitant 150 mg

Serious: 6/111 (5%)

Deaths: —

Serious adverse events (11 terms)

Reaction	System	Fosaprepitant 150 mg
Febrile neutropenia	Blood and lymphatic system disorders	—
Neutropenia	Blood and lymphatic system disorders	—
Eructation	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Chest pain	General disorders	—
Fatigue	General disorders	—
Injection site extravasation	General disorders	—
Pyrexia	General disorders	—
Sepsis	Infections and infestations	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (9 terms — click to expand)

Reaction	System	Fosaprepitant 150 mg
Fatigue	General disorders	—
Constipation	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Headache	Nervous system disorders	—
Diarrhoea	Gastrointestinal disorders	—
Decreased appetite	Metabolism and nutrition disorders	—
Alopecia	Skin and subcutaneous tissue disorders	—
Eructation	Gastrointestinal disorders	—
Dizziness	Nervous system disorders	—

Most-reported serious reactions: Febrile neutropenia, Neutropenia, Eructation, Nausea, Vomiting, Chest pain, Fatigue, Injection site extravasation.

Data from ClinicalTrials.gov NCT01405924 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.