NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens

NCT06331520 | Completed Phase 3

• 1 other identifier: Desineo
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.

Conditions

Highly Emetogenic Chemotherapy; Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with complete response (CR)

  Percentage of patients with complete response (CR) defined defined as no vomiting with no use of rescue therapy

  Within 0-120 hours from the initiation of chemotherapy

Secondary Outcomes (5)

• Percentage of Patients With CR (acute and delayed)

  From the initiation of chemotherapy infusion(0h)up to beginning of day 6(-120 h)

• Percentage of patients with overall complete protection(OCP)

  During the acute (within 24 hours post-chemotherapy) and delayed (days 2 thorough 5) phases of chemotherapy

• Percentage of patients with overall total control (OTC)

  During 0 ~ 24 hours and 0 ~ 168 hours post-chemotherapy

• incidence of adverse events

  From initiation of chemotherapy to 168 hours after initiation of chemotherapy

• quality of life questionnaire

  From initiation of chemotherapy to 168 hours after initiation of chemotherapy

Study Arms (3)

NEO-DXMS GROUP

ACTIVE COMPARATOR

NEPA(1 capsule, day1, PO)+ Olanzapine(5mg, day1-4, PO)+ dexamethasone(12mg, day1; 8mg day2-4, PO/IV).

Drug: Netupitant / Palonosetron Oral Capsule [Akynzeo]; Drug: Olanzapine; Drug: Dexamethasone Oral

HALF-DXMS GROUP

ACTIVE COMPARATOR

NEPA(1 capsule, day1, PO)+ Olanzapine(5mg, day1-4, PO)+ dexamethasone(6mg, day1, PO/IV)

Drug: Netupitant / Palonosetron Oral Capsule [Akynzeo]; Drug: Olanzapine; Drug: Dexamethasone Oral

NEO GROUP

EXPERIMENTAL

NEPA(1 capsule, day1, PO)+ Olanzapine(5mg, day1-4, PO).

Drug: Netupitant / Palonosetron Oral Capsule [Akynzeo]; Drug: Olanzapine

Interventions

Netupitant / Palonosetron Oral Capsule [Akynzeo] DRUG

Akynzeo is the fixed-combination antiemetic comprising netupitant (neurokinin-1 receptor antagonist \[NK1 RA\]) and palonosetron (5-hydroxytryptamine-3 receptor antagonist \[5-HT3 RA\]).

HALF-DXMS GROUP; NEO GROUP; NEO-DXMS GROUP

Olanzapine DRUG

Olanzapine is an effective antipsychotic drug used in psychiatry to treat psychoses, especially schizophrenia and schizoaffective disorders. It belongs to the 2nd generation antipsychotics, its mechanism of action ranks among multireceptor antagonists (MARTA); it affects the dopamine, serotonin, adrenaline, histamine, and muscarinic systems.

HALF-DXMS GROUP; NEO GROUP; NEO-DXMS GROUP

Dexamethasone Oral DRUG

synthetic glucocorticoids

HALF-DXMS GROUP; NEO-DXMS GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥18 years old
• Patients who receive the high-emetic-risk anticancer agents.
• Patients who do not take a medicine, for example, 5HT3 receptor antagonists, NK1 receptor antagonists, or research related agents, within 3 weeks prior to enrollment.
• No nausea or vomiting (grade II or above) within 72 hours before the start of chemotherapy.
• Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Subject has a life Expectation of at least 12 weeks.
• In accordance with the indication of chemotherapy and basic requirements： Peripheral haematology: Hb ≥9.0g/dL; absolute neutrophil count ≥1.5×109/L; Platelet count ≥80×109/L Blood biochemistry: Total bilirubin \< 1.25×ULN, ALT and AST ≤ 2.5×ULN; If liver metastasis, ALT and AST \< 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca) Other important organs function normally.
• Female patients of either non-childbearing potential or child-bearing potential use contraceptive methods throughout the clinical trial.
• Female patients with child-bearing potential must is negative of pregnancy test.
• Subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent
• Subjects can independently fill out patient diaries.

You may not qualify if:

• Patients receiving moderate or high emetic radioation therapy within 1 week before chemotherapy or day 1 to 5 after chemotherapy.
• Within 24 hours after chemotherapy, patients receiving any known or potential antiemetic agents and appearing symptoms vomiting, nausea, or mild nausea symptoms.
• Scheduled to receive inducer or substrate or strong / moderate inhibitor of cytocrome P450 3A4 (CYP3A4) within 3 weeks prior to day 1.
• Patients who cannot tolerate chemotherapy drugs.
• Serious cardiovascular, pulmonary disease, diabetes, mental and other diseases.
• Pregnant , breastfeeding and woman with child-bearing potential who are unwilling or unable to take effective contraceptive measures.
• Drug addict or alcohol abuse.
• Hypocalcemia or any other condition that may cause vomiting.
• Patients has significant factors that affect the absorption of oral medication, such as chronic diarrhea or obstruction.
• Subjects has hypersensitivity to netupitant/palonostron capsules or any of its excipients.
• Scheduled to receive any antiemetic agents within 3 weeks prior to day 1(including but not limited to: neurokin-1 (NK1) receptor antagonist, 5-HT3 receptor antagonists, olanzapine, scopolamine,et al.).
• Scheduled to receive benzodiazepine, opioid or opioid derivatives (except midazolam, temazepam or triazolam)within 1 week before chemotherapy or day 1 to 5 after chemotherapy.
• Subjects are currently enrolled in an other clinical study with any other clinical trials, investigational drugs or observational studies within 21 days of baseline.
• Investigators judged other situations that may affect the progress and results of clinical research.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Cancer

Shanghai, Shanghai Municipality, 200043, China

Location

MeSH Terms

Conditions

Vomiting

Interventions

netupitant; Palonosetron; netupitant, palosentron drug combination; Olanzapine; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jian Zhang, MD,PhD

  Phase I Unit, Fudan University Shanghai Cancer Center, Shanghai, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Phase I Clinical Trial Department; Professor, Chief physician of oncology department

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: March 26, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 30, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (1)