Trial Outcomes & Findings for Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy (NCT NCT01504711)

NCT ID: NCT01504711

Last Updated: 2021-04-08

Results Overview

Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: From 0-120 hours after first course of chemotherapy
• Results posted on: 2021-04-08

Participant Flow

Participant milestones

Measure	Treatment (Nausea and Vomiting Prophylaxis) Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy

Baseline characteristics by cohort

Measure	Treatment (Nausea and Vomiting Prophylaxis) n=27 Participants Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	56.0 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: From 0-120 hours after first course of chemotherapy

Population: The analysis set includes patients (n=26) who returned an outcomes diary at 24 or 120 hours post treatment. 1 patient could not be evaluated as they did not return their diary.

Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.

Outcome measures

Measure	Treatment (Nausea and Vomiting Prophylaxis) n=26 Participants Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Percentage of Participants With Control of Vomiting and Rescue Medication Control	26.9 percentage of participants Interval 15.3 to 42.9

SECONDARY outcome

Timeframe: in approximately 28 months

Population: The analysis set includes patients (n=26) who returned an outcomes diary at 24 or 120 hours post treatment. 1 patient could not be evaluated as they did not return their diary.

Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.

Outcome measures

Measure	Treatment (Nausea and Vomiting Prophylaxis) n=26 Participants Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Percentage of Participants With Control of Both Acute and Delayed Vomiting	65.4 percentage of participants Interval 49.3 to 78.6

SECONDARY outcome

Timeframe: in approximately 28 months

Population: The analysis set includes patients (n=25) who returned an outcomes diary at 24 or 120 hours post treatment with nausea information filled out. 2 patients could not be evaluated as they did not return their diary with nausea information filled out.

Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.

Outcome measures

Measure	Treatment (Nausea and Vomiting Prophylaxis) n=25 Participants Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Percentage of Participants With Control of Both Acute and Delayed Nausea	28.0 percentage of participants Interval 16.0 to 44.3

SECONDARY outcome

Timeframe: Time of initiation of treatment until death or censor assessed up to 26 months

Outcome measures

Measure	Treatment (Nausea and Vomiting Prophylaxis) n=27 Participants Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV
Overall Survival	11.5 months Interval 4.8 to 15.5

Adverse Events

All Participants

Serious events: 3 serious events

Other events: 12 other events

Deaths: 22 deaths

Serious adverse events

Measure	All Participants n=27 participants at risk All participants
Gastrointestinal disorders GI bleed from gastric ulcer	3.7% 1/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
Gastrointestinal disorders Uncontrolled nausea	3.7% 1/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
Gastrointestinal disorders bowel obstruction	3.7% 1/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
Gastrointestinal disorders intractable nausea	3.7% 1/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).

Other adverse events

Measure	All Participants n=27 participants at risk All participants
Gastrointestinal disorders Vomiting	14.8% 4/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
General disorders Hypokalemia	11.1% 3/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
General disorders Dehydration	11.1% 3/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
General disorders Anemia	11.1% 3/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
General disorders Hyponatremia	7.4% 2/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
General disorders Decreased white blood cell count	7.4% 2/27 • The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).

Additional Information

Dr. Philip A. Philip, M.D., Ph.D., F.R.C.P

Barbara Ann Karmanos Cancer Institute

Phone: (313)576-8624

Email: philipp@karmanos.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place