Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy

• Status: Unknown status
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed to evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients receiving 3-day cisplatin-based chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; BB 1101; Cisplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Palonosetron

Criteria

Inclusion Criteria:

1. Patient who was confirmed lung cancer by pathologic histology or cytology.

2. Males or females aged ≥18 years, <80 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.

4. Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.

5. Patients with asymptomatic, treated brain metastases are eligible for trial participation.

6. Adequate bone marrow, renal, and liver function are required.

7. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

8. Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria:

1. History of sensitivity/idiosyncrasy to aprepitant or excipients

2. Condition that might interfere with drug absorption, distribution metabolism or excretion.

3. Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics

4. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

5. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.

6. Female subjects should not be pregnant or breast-feeding.

7. Inadequate hematological function.

8. Abnormal liver and renal function.

9. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.