Head and Neck CancerPhase 2NCT04529850
Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
A Phase 2 study testing Drug: GC4419, Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Head and Neck Cancer and Oral Mucositis, run by Galera Therapeutics, Inc. at 24 sites in 6 countries.
Trial summary
GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oral Mucositis
- What is being tested?
- Drug: GC4419, Intensity-modulated radiation therapy (IMRT) and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 30 Jun 2020to 10 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
- Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.
- Patients who have had prior surgery may be eligible,
- Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses).
- Age 18 years or older
- ECOG performance status ≤ 2
- Adequate hematologic function
- Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN
Who cannot join
- Metastatic disease
- Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
- Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
- Planned concurrent chemotherapy other than single agent cisplatin
- Receiving any approved or investigational anti-cancer agent
- Concurrent participation in another interventional clinical study
Show all 15Show fewer
- Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
- Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
- Malignant tumors other than head and neck cancer (HNC) within the last 5 years
- Active infectious disease excluding oral candidiasis
- Presence of oral mucositis at baseline.
- Known history of human immunodeficiency virus (HIV) or active hepatitis B/C
- Female patients who are pregnant or breastfeeding
- Known allergies or intolerance to cisplatin and similar platinum-containing compounds
- Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating Investigator, create a risk for a precipitous decrease in blood pressure.
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Spain11 sites
Complejo Hospitalario Universitario De Santiago De Compostela
A Coruña
Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces
Barakaldo
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario de Fuenlabrada
Fuenlabrada
Institut Catala d'Oncologia de Girona
Girona
Complejo Hospitalario de Jaen
Jaén
Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal)
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Complejo Hospitalario de Navarra (CHN)
Pamplona
Hospital universitario Virgen del Rocio
Salamanca
Universidad de Salamanca - Hospital Clinico Universitario
Salamanca
Belgium4 sites
Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
Aalst
AZ Klina
Brasschaat
Az Nikolaas
Sint-Niklaas
CHR Verviers
Verviers
Poland4 sites
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow
Szpitale Pomorskie Sp. z o.o.
Pomorskie
Cancer Center Institute of Oncology
Warsaw
Germany2 sites
University Medical Center Schleswig-Holstein
Kiel
Universitatsklinikum Leipzig AoR
Leipzig
Switzerland2 sites
University Hospital Basel
Basel
University Hospital of Bern, Inselspital
Fribourg
About this study
Official title: An Open Label Multi-Center Study of the Effects of GC4419 When Administered to Reduce the Incidence and Severity of Severe Oral Mucositis Associated With Chemo RT for Locally Advanced, Non-Metastatic Head and Neck Cancer
GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)
Read the detailed description
Subjects will receive 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks, plus cisplatin administered 100 mg/m2 once every three weeks for 3 doses or 40 mg/m2 once weekly for 6-7 doses (Investigator's choice).
All subjects will be assessed twice weekly for Oral Mucositis (OM) per WHO grading criteria until 28 days post end of study treatment period (last day of IMRT).
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Being tested
- Drug: GC4419, Intensity-modulated radiation therapy (IMRT), Cisplatin
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: GC4419Drug
GC4419 60 Minute Infusion
Intensity-modulated radiation therapy (IMRT)Radiation
2.0 to 2.2 Gy daily over 7 weeks
CisplatinDrug
100mg/m2 once every 3 weeks or 40mg/m2 once weekly for 6-7 doses
| Study group | Role | What they receive |
|---|---|---|
| Open Label Active Arm | Experimental | 90mg GC4419 by IV Receives: Drug: Drug: GC4419; Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent AE's
Number of Subjects with at Least One Treatment Emergent Adverse Event (TEAE)
Measured: First dose of study medication through the 30 days following the last dose of IMRT, GC4419, or cisplatin (whichever occurs last) which is estimated to be 11 weeks
Secondary outcomes (1)
Cumulative Incidence of Severe OM
Cumulative Incidence of WHO Grade 3-4 from the start of IMRT through the end of the study treatment period (last day of IMRT)
Measured: From start of Intensity-modulated radiation therapy (IMRT) through approximately 30 fractions which is estimated to be 6-7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start30 Jun 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To evaluate the effects of GC4419 in subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Holmlund, MD, Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529850
- Sponsor's protocol ID
- GTI-4419-202
- Status last verified
- Jan 2022
- First submitted
- 13 Aug 2020
- Last updated
- 16 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multi-Center Study of the Effects of GC4419 When Administered to Reduce the Incidence and Severity of Severe Oral Mucositis Associated With Chemo RT for Locally Advanced, Non-Metastatic Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04529850
- Acronym / sponsor ID
- GTI-4419-202
- Conditions
- Head and Neck Cancer, Oral Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Posted 16 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)
Detailed description
Subjects will receive 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks, plus cisplatin administered 100 mg/m2 once every three weeks for 3 doses or 40 mg/m2 once weekly for 6-7 doses (Investigator's choice).
All subjects will be assessed twice weekly for Oral Mucositis (OM) per WHO grading criteria until 28 days post end of study treatment period (last day of IMRT).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate the effects of GC4419 in subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)
| Arm | Type | Receives |
|---|---|---|
| Open Label Active Arm | Experimental | Drug: Drug: GC4419, Radiation: Intensity-modulated radiation therapy (IMRT), Drug: Cisplatin90mg GC4419 by IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
- Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.
- Patients who have had prior surgery may be eligible,
- Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses).
- Age 18 years or older
Key exclusion criteria (15 listed)
- Metastatic disease
- Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
- Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
- Planned concurrent chemotherapy other than single agent cisplatin
- Receiving any approved or investigational anti-cancer agent
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 |
|---|---|---|
| Drug: GC4419GC4419 60 Minute Infusion | Drug | Open Label Active Arm |
| Intensity-modulated radiation therapy (IMRT)2.0 to 2.2 Gy daily over 7 weeks | Radiation | Open Label Active Arm |
| Cisplatin100mg/m2 once every 3 weeks or 40mg/m2 once weekly for 6-7 doses | Drug | Open Label Active Arm |
Primary outcome
Incidence of Treatment Emergent AE's
Time frame: First dose of study medication through the 30 days following the last dose of IMRT, GC4419, or cisplatin (whichever occurs last) which is estimated to be 11 weeks
Number of Subjects with at Least One Treatment Emergent Adverse Event (TEAE)
1 secondary outcome
Cumulative Incidence of Severe OM
Time frame: From start of Intensity-modulated radiation therapy (IMRT) through approximately 30 fractions which is estimated to be 6-7 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jon Holmlund, MD study chair
Chief Medical Officer
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: GC4419, Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Head and Neck Cancer and Oral Mucositis, run by Galera Therapeutics, Inc. at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. 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: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Spain, Belgium, Poland, Germany, Switzerland and 1 more country. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent AE's (time frame: First dose of study medication through the 30 days following the last dose of IMRT, GC4419, or cisplatin (whichever occurs last) which is estimated to be 11 weeks). 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 16 Aug 2022.