Germ Cell CancerEarly Phase 1SPARROW-GCNCT07662200
A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy
A Early Phase 1 study testing Netupitant/Palonosetron Hydrochloride, Aprepitant and Dexamethasone in people with Germ Cell Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Germ Cell Cancer
- What is being tested?
- Netupitant/Palonosetron Hydrochloride, Aprepitant and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2026to Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Diagnosis of germ cell cancer
- Indication for outpatient treatment using a standard 5-day cisplatin-based chemotherapy regimen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Dominick Bossé, Medical Oncologist, 1-613-737-7700 ext. 70166, dbosse@toh.ca
About this study
Official title: A Pilot Feasibility Study of a Steroid-Sparing Anti-Nausea and Vomiting Regimen With Netupitant/Palonosetron for Patients With Germ Cell Tumours Receiving Multi-Day Cisplatin-Based Chemotherapy at The Ottawa Hospital
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
- Being tested
- Netupitant/Palonosetron Hydrochloride, Ondansetron (Control), Aprepitant, Dexamethasone, Olanzapine
- Keywords
- SPARROW-GC, Netupitant, Palonosetron, Steroid-Sparing Anti-Nausea and Vomiting Regimen
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netupitant/Palonosetron HydrochlorideDrug
300mg/0.5mg combination pill taken once daily by mouth on the first and third day of chemotherapy
Ondansetron (Control)Drug
8mg taken twice daily by mouth for 5 days
AprepitantDrug
Daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day
DexamethasoneDrug
Daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days)
OlanzapineDrug
5mg taken at night by mouth for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Netupitant/Palonosetron Hydrochloride; Drug: Dexamethasone; Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 1 year
Secondary outcomes (4)
Complete Response (CR)
To evaluate the CR after Cycle 1
Measured: After Cycle 1 (Each cycle is 7 days)
Early Complete Response, late Complete Response and total control
To evaluate the response at the end of the study
Measured: 1 year
Review toxicities
Describe patient-reported toxicities using PRO-CTCAE
Measured: 1 year
Quality of Life outcomes
Describe the quality of life outcomes using the Functional Living Index Emesis (FLIE)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662200
- Sponsor's protocol ID
- OHRI SPARROW-GC
- Acronym
- SPARROW-GC
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of a Steroid-Sparing Anti-Nausea and Vomiting Regimen With Netupitant/Palonosetron for Patients With Germ Cell Tumours Receiving Multi-Day Cisplatin-Based Chemotherapy at The Ottawa Hospital
- ClinicalTrials.gov ID
- NCT07662200
- Acronym / sponsor ID
- SPARROW-GC / OHRI SPARROW-GC
- Conditions
- Germ Cell Cancer
- Keywords
- SPARROW-GC, Netupitant, Palonosetron, Steroid-Sparing Anti-Nausea and Vomiting Regimen
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Ondansetron (Control), Drug: Aprepitant, Drug: Dexamethasone, Drug: Olanzapine1. 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 |
| Group 2 | Experimental | Drug: Netupitant/Palonosetron Hydrochloride, Drug: Dexamethasone, Drug: Olanzapine1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Netupitant/Palonosetron Hydrochloride300mg/0.5mg combination pill taken once daily by mouth on the first and third day of chemotherapy | Drug | Group 2 |
| Ondansetron (Control)8mg taken twice daily by mouth for 5 days | Drug | Group 1 |
| AprepitantDaily by mouth on the first (125mg), third (80mg), and fifth (80mg) day | Drug | Group 1 |
| DexamethasoneDaily by mouth for 7 days (12mg on the first day, 8mg on subsequent days) | Drug | Group 1, Group 2 |
| Olanzapine5mg taken at night by mouth for 7 days | Drug | Group 1, Group 2 |
Primary outcome
Feasibility of study
Time frame: Through study completion, up to 1 year
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.
4 secondary outcomes
Complete Response (CR)
Time frame: After Cycle 1 (Each cycle is 7 days)
Early Complete Response, late Complete Response and total control
Time frame: 1 year
Review toxicities
Time frame: 1 year
Quality of Life outcomes
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Germ Cell Cancer
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Netupitant/Palonosetron Hydrochloride, Aprepitant and Dexamethasone in people with Germ Cell Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominick Bossé, M.D. (1-613-737-7700 ext. 70166, dbosse@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study (time frame: Through study completion, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.