The study assesses efficacy and safety of a single oral dose of a fixed combination of netupitant/palonosetron 300/0.5 mg vs oral palonosetron 0.5 mg, both with oral dexamethasone, to demonstrate the combination is more effective of palonosetron alone in preventing nausea/vomiting by chemotherapy.

Phase 3

• Conditions: Health Condition 1: null- prevention of nausea and vomiting incancer patients receiving moderately emetogenic chemotherapy

• Registration Number: CTRI/2011/12/002296
• Lead Sponsor: Helsinn Healthcare SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 1460

Inclusion Criteria

1. Signed written informed consent. 2. Male or female patient greater or equal than 18 years of age. 3. Naïve to cytotoxic chemotherapy. Previous

biological or hormonal therapy will be permitted. 4. Scheduled to receive first course of an anthracycline and cyclophosphamide containing moderately emetogenic chemotherapy (MEC) regimen for the treatment of a solid malignant tumor: cyclophosphamide I.V. (500 to 1500 mg/m2)

and I.V. doxorubicin (greater or equal than 40 mg/m2) or cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. epirubicin (greater or equal than 60 mg/m2). 5. If scheduled to receive chemotherapy

agents of minimal to low emetogenic potential they could be given on any day. 6. ECOG Performance Status of 0, 1, or 2. 7. Female patients of either: a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal. For purposes of this study, postmenopausal is defined as 12 consecutive months of amenorrhea.The following inclusion criteria must be checked prior inclusion at each

cycle of the Multiple-Cycle Extension: 1. Participation in the study during the next cycle of chemotherapy is considered appropriate by the investigator and does not pose unwarranted risk to the patient. 2. Satisfactory study compliance in the preceding cycle of chemotherapy and related study procedures. 3. Scheduled to receive the same chemotherapy regimen as cycle 1 as defined in Inclusion Criterion n. 4.

4. Adequate hematologic and metabolic status as defined by Inclusion Criterion n. 8.

Exclusion Criteria

1. If female, pregnant or lactating. 2. Current use of illicit drugs or current evidence of alcohol abuse. 3. Scheduled to receive any highly

emetogenic chemotherapy (HEC) from Day 1 to Day 5 or moderately emetogenic chemotherapy (MEC) from Day 2 to Day 5 following the allowed MEC regimen. 4. Received or is scheduled to receive radiation

therapy to the abdomen or the pelvis within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1. 5.Any vomiting, retching, or mild nausea

(grade greater or equal than I as defined by National Cancer Institute) within 24 hours prior to Day 1. 6. Symptomatic primary or metastatic

CNS malignancy. 7. Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active

infection or any uncontrolled medical condition (other than malignancy) that, in the opinion of the investigator, may confound the results of the

study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting, CINV) or pose

unwarranted risks in administering the study drugs to the patient. 8. Known hypersensitivity or contraindication to 5-HT3 receptor

antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron,tropisetron, ramosetron) or dexamethasone. 9. Previously received an

NK1 receptor antagonist (e.g., aprepitant, casopitant). 10. Participation in a clinical trial involving oral netupitant administered in combination with palonosetron. 11. Any investigational drugs taken within 4 weeks

prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study.Exclusion Criteria (Multiple-Cycle Extension):The following exclusion criteria must be checked prior inclusion at each cycle of the Multiple-Cycle Extension: 1. If female, pregnant or lactating, i.e. positive urine dipstick pregnancy test within 24 hours prior to Day 1.

2. Active infection or uncontrolled disease except for malignancy. 3.Started any of the restricted medications. 4. Any vomiting, retching, or mild nausea (grade greater or equal than I as defined by National Cancer

Institute) within 24 hours prior to Day 1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified