A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy

NCT07662200 | Not Yet Recruiting Early Phase 1

• 1 other identifier: OHRI SPARROW-GC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-site, open-label, randomized pilot feasibility study conducted at The Ottawa Hospital Cancer Centre. A total of 10 participants will be randomized 1:1 to either the experimental or control arm. The purpose of this study is to evaluate recruitment capability, intervention adherence, data completeness, and safety prior to consideration of a potential future multi-centre randomized trial.

Conditions

Germ Cell Cancer

Keywords

SPARROW-GC; Netupitant; Palonosetron; Steroid-Sparing Anti-Nausea and Vomiting Regimen

Outcome Measures

Primary Outcomes (1)

• Feasibility of study

  To measure the feasibility of the study, the researchers will collect the recruitment rate, the consent rate among eligible patients, the completion of symptom and quality-of-life assessments, the adherence to protocol, the frequency of protocol deviations and safety events.

  Through study completion, up to 1 year

Secondary Outcomes (4)

• Complete Response (CR)

  After Cycle 1 (Each cycle is 7 days)

• Early Complete Response, late Complete Response and total control

  1 year

• Review toxicities

  1 year

• Quality of Life outcomes

  1 year

Study Arms (2)

Group 1

ACTIVE COMPARATOR

1. Ondansetron 8mg taken twice daily by mouth for 5 days 2. Aprepitant taken daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day. 3. Dexamethasone taken daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days) 4. Olanzapine 5mg taken at night by mouth for 7 days

Drug: Ondansetron (Control); Drug: Aprepitant; Drug: Dexamethasone; Drug: Olanzapine

Group 2

EXPERIMENTAL

1. Netupitant/Palonosetron\* (300mg/0.5mg) combination pill taken once daily by mouth on the first and third day of chemotherapy 2. Dexamethasone 4mg taken once daily by mouth for 5 days 3. Olanzapine 5mg taken at night by mouth for 7 days

Drug: Netupitant/Palonosetron Hydrochloride; Drug: Dexamethasone; Drug: Olanzapine

Interventions

Netupitant/Palonosetron Hydrochloride DRUG

300mg/0.5mg combination pill taken once daily by mouth on the first and third day of chemotherapy

Group 2

Ondansetron (Control) DRUG

8mg taken twice daily by mouth for 5 days

Group 1

Aprepitant DRUG

Daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day

Group 1

Dexamethasone DRUG

Daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days)

Group 1; Group 2

Olanzapine DRUG

5mg taken at night by mouth for 7 days

Group 1; Group 2

Eligibility Criteria

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

1. Diagnosis of germ cell cancer 2. Indication for outpatient treatment using a standard 5-day cisplatin-based chemotherapy regimen

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

netupitant; Palonosetron; Ondansetron; Aprepitant; Dexamethasone; Olanzapine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Morpholines; Oxazines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzodiazepines; Benzazepines

Central Study Contacts

Dominick Bossé, M.D.

CONTACT

1-613-737-7700; dbosse@toh.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

CA (1)