Study Title
A phase 3 multicenter, randomized, double-blind, active control study to evaluate the safety and efficacy of IV pro-netupitant/palonosetron (260mg/0.25mg) combination for the prevention of chemotherapy-induced nausea and vomiting in repeated chemotherapy cycles in patients receiving highly emetogenic chemotherapy
Malignancy
x- HEC for breast cancer, head and neck cancer, hematologic malignancies, leukemia, lymphoma, lung cancer, bladder cancer
Line Of Therapy
1st Line (Prior targeted or endocrine therapy allowed)
Investigational Agent
IV Pro-Netupitant/Palonosetron Fixed Dose Combination
Drug Class
Fixed dose combination NK1 antagonist + 5-HT3 antagonist
Key Eligibility Criteria Details
- Naïve to cytotoxic chemotherapy (endocrine or targeted therapy allowed)
- Scheduled to receive at least 4 repeated consecutive cycles with one of the following reference HEC (alone or in combination with other chemo agents) on Day 1
- Cisplatin as single IV dose >70mg/m2
- Cyclophosphamide >1500mg/m2
- Carmustine (BCNU) >250 mg/m2
- Dacarbazine (DTIC)
- Mechloretamine (nitrogen mustard)
- ECOG PS 0-2
- Adequate laboratory values
- Cannot be scheduled to receive MEC or HEC on Day 2-5 of a cycle
- No active nausea of vomiting in 24 hours prior to chemo
- No symptomatic CNS disease
- No systemic steroids within 3 days of HEC
- No anti-emetic medicine within 24 hours of HEC
Objective
Primary- Safety and Tolerability; Secondary- CR during all phases, no emetic episodes, no significant nausea
