NCT03237611

Low Dose Aprepitant for Patients Receiving Carboplatin

Terminated Phase 2 Results posted Last updated 13 November 2023

What this trial tests

Phase 2 trial testing Aprepitant 125 mg in Chemotherapy-induced Nausea and Vomiting in 15 participants. Terminated before completion.

Timeline

30 October 2018

Primary endpoint
11 February 2021

11 February 2021

Quick facts

Lead sponsor	Albert Einstein College of Medicine
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	30 October 2018
Primary completion	11 February 2021
Estimated completion	11 February 2021
Sites	2 locations across United States

Drugs / interventions tested

• Aprepitant 125 mg — full drug profile →
• Fosaprepitant 115 MG — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Ondansetron 16 MG — full drug profile →

Conditions studied

• Chemotherapy-induced Nausea and Vomiting — all drugs for Chemotherapy-induced Nausea and Vomiting →

Sponsor

Albert Einstein College of Medicine

Who can join

18 and older, any sex, with Chemotherapy-induced Nausea and 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.

Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy Primary · 24 hours following the first cycle of chemotherapy

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.

Vomiting

Group	Value	95% CI
Low Dose Aprepitant or Fosaprepitant	11

Nausea

Group	Value	95% CI
Low Dose Aprepitant or Fosaprepitant	10

Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 1st Cycle of Chemotherapy Primary · From 24 to 120 hours following the first cycle of chemotherapy, approximately 5 days

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.

Vomiting

Group	Value	95% CI
Low Dose Aprepitant or Fosaprepitant	9

Nausea

Group	Value	95% CI
Low Dose Aprepitant or Fosaprepitant	9

Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy Secondary · 24 hours following the second cycle of chemotherapy

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.

Vomiting

Group	Value	95% CI
Low Dose Aprepitant or Fosaprepitant	3

Nausea

Group	Value	95% CI
Low Dose Aprepitant or Fosaprepitant	3

Complete Control Rate of Chemotherapy-induced Nausea and Vomiting (CINV) Following 2nd Cycle of Chemotherapy Secondary · From 24 to 120 hours following the second cycle of chemotherapy, approximately 5 days

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.

Vomiting

Group	Value	95% CI
Low Dose Aprepitant or Fosaprepitant	3

Nausea

Group	Value	95% CI
Low Dose Aprepitant or Fosaprepitant	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Low Dose Aprepitant or Fosaprepitant

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (1 terms — click to expand)

Reaction	System	Low Dose Aprepitant or Fos…
Hiccups	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT03237611 adverse events section.

Sponsor's own description

This study evaluates a simple one day prophylaxis of nausea and vomiting for patients who are getting carboplatin based chemotherapy. In addition to standard oral Dexamethasone and oral Ondansetron, participants will be given a third neurokinin 1 (NK1) antagonist agent, either a single dose of oral Aprepitant or intravenous (IV) Fosaprepitant (they have been shown to be equally effective) to improve prevention of nausea and vomiting. No medications need to be taken beyond day 1.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.