Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin

• Status: Active, not recruiting
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the possibility to reduce the total dose of dexamethasone, when administered with NEPA, to prevent chemotherapy-induced nausea and vomiting (CINV) in Non-Small Cell Lung Cancer (NSCLC) patients receiving a cisplatin-based chemotherapy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Consorzio Oncotech
• Treatments: BB 1101; Cisplatin; Dexamethasone; Dexamethasone acetate; Palonosetron

Criteria

Inclusion Criteria:

• Patients ≥ 18 years old.

• Histologically or cytologically confirmed diagnosis of NSCLC

• Patients naїve to cisplatin-containing chemotherapy as well as any prior chemotherapy containing either highly or moderately emetogenic agents given for NSCLC or other malignancy.

• Patients scheduled to receive their first cycle of cisplatin-based chemotherapy at a dose ≥70 mg/m2 either alone or in combination with other agents of low or minimal potential of emetogenicity (i.e., pemetrexed, gemcitabine±bevacizumab, vinorelbine) as neo-adjuvant, adjuvant or palliative therapy. Patients with progressive disease on therapy with an EGFR-TKI (Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) and scheduled to receive cisplatin-based chemotherapy will be eligible for the study.

• ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-1.

• Body Mass Index ≥18.5.

• Written informed consent before study entry.

• If women of childbearing potential age: effective contraceptive measures must be used during all the planned course of chemotherapy and up to 30 days after last NEPA administration.

• Normal hepatic function (≤2 times the upper limit of normal for liver transaminases) and renal function (creatinine ≤ 1.5 times the upper limit of normal).

• Ability and willingness of the patient to complete the diary and study questionnaires.

Exclusion Criteria:

• Symptomatic brain metastases.

• Patients scheduled to receive radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5 following the first cycle of chemotherapy.

• Patients scheduled to receive concurrent chemo/radiotherapy for NSCLC.

• Treatment with investigational medications within 30 days before the study medication.

• Myocardial infarction within the last 6 months.

• Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK-1RA (Neurokinin-1 Receptor Antagonist) and excipients (see section 6.1 of Akynzeo SPC).

• Uncontrolled diabetes mellitus or active infection.

• Nausea and vomiting in the 24 hours before study treatment.

• Chronic use of systemic corticosteroids (except for topical and inhaled corticosteroids) or any other agent with anti-emetic potential. Patients receiving dexamethasone on the day before chemotherapy for prevention of the pemetrexed-induced skin rash will be eligible for the study.

• Patient's inability to take oral medication.

• Gastrointestinal obstruction or active peptic ulcer.

• Pregnancy or breast feeding.

• Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for at least 5 years (see also inclusion criteria if prior chemotherapy treatment).

• Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol.