Trial Outcomes & Findings for Low Dose Aprepitant for Patients Receiving Carboplatin (NCT NCT03237611)

Results Overview

Complete control rate of nausea and vomiting is defined as the percentage of patients without episodes of nausea or emesis, or rescue medication administered, during the overall phase of the first carboplatin-based chemotherapy cycle. Data was collected by administration of the MASCC Antiemesis Tool. The MASCC Antiemesis Tool is an eight-item questionnaire administered to patients to assess the occurrence of vomiting and nausea both during the first 24 hours after chemotherapy as well as the occurrence of delayed nausea and vomiting from the day after to 120 hours after chemotherapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

24 hours following the first cycle of chemotherapy

Results posted on

2023-11-13

Participant Flow

For purposes of this single arm study, the determination of whether fosaprepitant or aprepitant was administered was entirely the choice of the ordering oncologist. Both agents are NK-1 receptor antagonists. Fosaprepitant is a phosphorylated analog of aprepitant and rapidly converts to aprepitant following IV injection.

Participant milestones

Participant milestones
Measure	Low Dose Aprepitant or Fosaprepitant In addition to standard prophylactic antiemetics (Ondansetron 16mg and Dexamethasone 20mg) patients will be given one dose of either aprepitant (125mg orally) or fosaprepitant (115mg intravenously) prior to the first cycle of carboplatin-based chemotherapy. No medications will be given afterwards Aprepitant 125 mg: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Fosaprepitant 115 MG: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Dexamethasone: Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy Ondansetron 16 MG: Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Dose Aprepitant or Fosaprepitant In addition to standard prophylactic antiemetics (Ondansetron 16mg and Dexamethasone 20mg) patients will be given one dose of either aprepitant (125mg orally) or fosaprepitant (115mg intravenously) prior to the first cycle of carboplatin-based chemotherapy. No medications will be given afterwards Aprepitant 125 mg: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Fosaprepitant 115 MG: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Dexamethasone: Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy Ondansetron 16 MG: Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Overall Study Withdrawal by Subject	1
Overall Study Ineligible	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose Aprepitant or Fosaprepitant n=15 Participants In addition to standard prophylactic antiemetics (Ondansetron 16mg and Dexamethasone 20mg) patients will be given one dose of either aprepitant (125mg orally) or fosaprepitant (115mg intravenously) prior to the first cycle of carboplatin-based chemotherapy. No medications will be given afterwards Aprepitant 125 mg: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Fosaprepitant 115 MG: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Dexamethasone: Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy Ondansetron 16 MG: Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Age, Continuous	58 years n=15 Participants
Sex: Female, Male Female	9 Participants n=15 Participants
Sex: Female, Male Male	6 Participants n=15 Participants
Region of Enrollment United States	15 participants n=15 Participants

PRIMARY outcome

Timeframe: 24 hours following the first cycle of chemotherapy

Population: Data was not collected for 2 of the patients who underwent carboplatin-based chemotherapy treatment. For purposes of this single arm study, the determination of whether fosaprepitant or aprepitant was administered was entirely the choice of the ordering oncologist. Both agents are NK-1 receptor antagonists. Fosaprepitant is a phosphorylated analog of aprepitant and rapidly converts to aprepitant following IV injection.

Complete control rate of nausea and vomiting is defined as the percentage of patients without episodes of nausea or emesis, or rescue medication administered, during the overall phase of the first carboplatin-based chemotherapy cycle. Data was collected by administration of the MASCC Antiemesis Tool. The MASCC Antiemesis Tool is an eight-item questionnaire administered to patients to assess the occurrence of vomiting and nausea both during the first 24 hours after chemotherapy as well as the occurrence of delayed nausea and vomiting from the day after to 120 hours after chemotherapy.

Outcome measures

Outcome measures
Measure	Low Dose Aprepitant or Fosaprepitant n=11 Participants In addition to standard prophylactic antiemetics (Ondansetron 16mg and Dexamethasone 20mg) patients will be given one dose of either aprepitant (125mg orally) or fosaprepitant (115mg intravenously) prior to the first cycle of carboplatin-based chemotherapy. No medications will be given afterwards Aprepitant 125 mg: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Fosaprepitant 115 MG: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Dexamethasone: Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy Ondansetron 16 MG: Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy Vomiting	11 Participants
Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy Nausea	10 Participants

PRIMARY outcome

Timeframe: From 24 to 120 hours following the first cycle of chemotherapy, approximately 5 days

Population: Data was not collected for 2 of the patients who underwent carboplatin-based chemotherapy treatment. For purposes of this single arm study, the determination of whether fosaprepitant or aprepitant was administered was entirely the choice of the ordering oncologist. Both agents are NK-1 receptor antagonists. Fosaprepitant is a phosphorylated analog of aprepitant and rapidly converts to aprepitant following IV injection.

Complete control rate of nausea and vomiting is defined as the percentage of patients without episodes of nausea or emesis, or rescue medication administered, during the overall phase of the first carboplatin-based chemotherapy cycle. Data was collected by administration of the MASCC Antiemesis Tool. The MASCC Antiemesis Tool is an eight-item questionnaire administered to patients to assess the occurrence of vomiting and nausea both during the first 24 hours after chemotherapy as well as the occurrence of delayed nausea and vomiting from the day after to 120 hours after chemotherapy.

Outcome measures

Outcome measures
Measure	Low Dose Aprepitant or Fosaprepitant n=11 Participants In addition to standard prophylactic antiemetics (Ondansetron 16mg and Dexamethasone 20mg) patients will be given one dose of either aprepitant (125mg orally) or fosaprepitant (115mg intravenously) prior to the first cycle of carboplatin-based chemotherapy. No medications will be given afterwards Aprepitant 125 mg: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Fosaprepitant 115 MG: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Dexamethasone: Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy Ondansetron 16 MG: Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy Vomiting	9 Participants
Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy Nausea	9 Participants

SECONDARY outcome

Timeframe: 24 hours following the second cycle of chemotherapy

Population: Only 3 participants underwent the second cycle chemotherapy treatment. For purposes of this single arm study, the determination of whether fosaprepitant or aprepitant was administered was entirely the choice of the ordering oncologist. Both agents are NK-1 receptor antagonists. Fosaprepitant is a phosphorylated analog of aprepitant and rapidly converts to aprepitant following IV injection.

Complete control rate of nausea and vomiting is defined as the percentage of patients without episodes of nausea or emesis, or rescue medication administered, during overall phase of the second chemotherapy cycle. Data was collected by administration of the MASCC Antiemesis Tool. The MASCC Antiemesis Tool is an eight-item questionnaire administered to patients to assess the occurrence of vomiting and nausea both during the first 24 hours after chemotherapy as well as the occurrence of delayed nausea and vomiting from the day after to 120 hours after chemotherapy.

Outcome measures

Outcome measures
Measure	Low Dose Aprepitant or Fosaprepitant n=3 Participants In addition to standard prophylactic antiemetics (Ondansetron 16mg and Dexamethasone 20mg) patients will be given one dose of either aprepitant (125mg orally) or fosaprepitant (115mg intravenously) prior to the first cycle of carboplatin-based chemotherapy. No medications will be given afterwards Aprepitant 125 mg: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Fosaprepitant 115 MG: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Dexamethasone: Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy Ondansetron 16 MG: Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy Nausea	3 Participants
Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy Vomiting	3 Participants

SECONDARY outcome

Timeframe: From 24 to 120 hours following the second cycle of chemotherapy, approximately 5 days

Population: Only 3 participants underwent the second cycle of chemotherapy treatment. For purposes of this single arm study, the determination of whether fosaprepitant or aprepitant was administered was entirely the choice of the ordering oncologist. Both agents are NK-1 receptor antagonists. Fosaprepitant is a phosphorylated analog of aprepitant and rapidly converts to aprepitant following IV injection.

Complete control rate of nausea and vomiting is defined as the percentage of patients without episodes of nausea or emesis, or rescue medication administered, during overall phase of the second chemotherapy cycle. Data was collected by administration of the MASCC Antiemesis Tool. The MASCC Antiemesis Tool is an eight-item questionnaire administered to patients to assess the occurrence of vomiting and nausea both during the first 24 hours after chemotherapy as well as the occurrence of delayed nausea and vomiting from the day after to 120 hours after chemotherapy.

Outcome measures

Outcome measures
Measure	Low Dose Aprepitant or Fosaprepitant n=3 Participants In addition to standard prophylactic antiemetics (Ondansetron 16mg and Dexamethasone 20mg) patients will be given one dose of either aprepitant (125mg orally) or fosaprepitant (115mg intravenously) prior to the first cycle of carboplatin-based chemotherapy. No medications will be given afterwards Aprepitant 125 mg: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Fosaprepitant 115 MG: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Dexamethasone: Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy Ondansetron 16 MG: Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy Vomiting	3 Participants
Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy Nausea	3 Participants

Adverse Events

Low Dose Aprepitant or Fosaprepitant

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Low Dose Aprepitant or Fosaprepitant n=13 participants at risk In addition to standard prophylactic antiemetics (Ondansetron 16mg and Dexamethasone 20mg) patients will be given one dose of either aprepitant (125mg orally) or fosaprepitant (115mg intravenously) prior to the first cycle of carboplatin-based chemotherapy. No medications will be given afterwards Aprepitant 125 mg: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Fosaprepitant 115 MG: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of either aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting Dexamethasone: Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy Ondansetron 16 MG: Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Respiratory, thoracic and mediastinal disorders Hiccups	7.7% 1/13 • Number of events 1 • Up to 120 hours following the first and second cycle of chemotherapy. Each cycle of chemotherapy is approximately 5 days in duration. Participants were monitored for adverse events up to a total of 2 weeks in aggregate. For purposes of this single arm study, the determination of whether fosaprepitant or aprepitant was administered was entirely the choice of the ordering oncologist. Both agents are NK-1 receptor antagonists. Fosaprepitant is a phosphorylated analog of aprepitant and rapidly converts to aprepitant following IV injection.

Additional Information

Dr. Richard Gralla

Albert Einstein College of Medicine

Phone: 718-918-6235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place