Trial Outcomes & Findings for Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030) (NCT NCT01405924)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

111 participants

Primary outcome timeframe

Up to 120 hours following initiation of chemotherapy in Cycle 2

Results posted on

2018-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Fosaprepitant 150 mg 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
Overall Study STARTED	111
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Fosaprepitant 150 mg 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
Overall Study Protocol Violation	8
Overall Study Missing/Incomplete Data	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fosaprepitant 150 mg n=111 Participants Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
Age, Continuous	52.83 Years STANDARD_DEVIATION 12.60 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 120 hours following initiation of chemotherapy in Cycle 2

Population: The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.

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.

Outcome measures

Outcome measures
Measure	Fosaprepitant 150 mg n=101 Participants Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy	Fosaprepitant 150 mg: CT Chemotherapy Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy	57.43 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to 120 hours following initiation of chemotherapy in Cycle 2

Population: The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data. Participants were grouped into 2 cohorts based on type of chemotherapy received.

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.

Outcome measures

Outcome measures
Measure	Fosaprepitant 150 mg n=61 Participants Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy	Fosaprepitant 150 mg: CT Chemotherapy n=40 Participants Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy	62.30 Percentage of Participants	50.00 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 120 hours following initiation of chemotherapy in Cycle 2

Population: The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.

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.

Outcome measures

Outcome measures
Measure	Fosaprepitant 150 mg n=101 Participants Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy	Fosaprepitant 150 mg: CT Chemotherapy Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy	21.78 Percentage of Participants	—

SECONDARY outcome

Timeframe: 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)

Population: The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.

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 questionnaire on the morning of Day 6 following initiation of chemotherapy in Cycle 2; their responses covered their experiences with nausea and vomiting over the previous 5 days.

Outcome measures

Outcome measures
Measure	Fosaprepitant 150 mg n=101 Participants Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy	Fosaprepitant 150 mg: CT Chemotherapy Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy Day 1 (prior to chemotherapy)	92.90 Score on a Scale Standard Deviation 9.58	—
Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy Day 6	80.50 Score on a Scale Standard Deviation 18.79	—

SECONDARY outcome

Timeframe: From 24 to 120 hours following initiation of chemotherapy in Cycle 2

Population: The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.

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.

Outcome measures

Outcome measures
Measure	Fosaprepitant 150 mg n=101 Participants Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy	Fosaprepitant 150 mg: CT Chemotherapy Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy	47.52 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to 120 hours following initiation of chemotherapy in Cycle 2

Population: The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.

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.

Outcome measures

Outcome measures
Measure	Fosaprepitant 150 mg n=101 Participants Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy	Fosaprepitant 150 mg: CT Chemotherapy Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy	30.69 Percentage of Participants	—

Adverse Events

Fosaprepitant 150 mg

Serious events: 6 serious events

Other events: 64 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fosaprepitant 150 mg n=111 participants at risk Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
Blood and lymphatic system disorders Febrile neutropenia	2.7% 3/111 • Number of events 3 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Blood and lymphatic system disorders Neutropenia	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Gastrointestinal disorders Eructation	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Gastrointestinal disorders Nausea	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Gastrointestinal disorders Vomiting	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
General disorders Chest pain	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
General disorders Fatigue	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
General disorders Injection site extravasation	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
General disorders Pyrexia	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Infections and infestations Sepsis	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.90% 1/111 • Number of events 1 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.

Other adverse events

Other adverse events
Measure	Fosaprepitant 150 mg n=111 participants at risk Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
Gastrointestinal disorders Constipation	21.6% 24/111 • Number of events 24 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Gastrointestinal disorders Diarrhoea	9.9% 11/111 • Number of events 11 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Gastrointestinal disorders Eructation	6.3% 7/111 • Number of events 7 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Gastrointestinal disorders Nausea	16.2% 18/111 • Number of events 19 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
General disorders Fatigue	24.3% 27/111 • Number of events 27 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Metabolism and nutrition disorders Decreased appetite	9.9% 11/111 • Number of events 12 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Nervous system disorders Dizziness	6.3% 7/111 • Number of events 7 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Nervous system disorders Headache	16.2% 18/111 • Number of events 21 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.
Skin and subcutaneous tissue disorders Alopecia	9.0% 10/111 • Number of events 10 • Up to Day 18 after study drug administration (Up to 18 days) The Safety Population consists of all participants who received a dose of study drug. Participants with breast cancers and gynecological cancers were pooled for safety analysis.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER