Oral MucositisPhase 1NCT06669390
A Mouthwash Medicine for the Reduction or Prevention of Mouth Ulceration Caused by Radiotherapy for Head and Neck Cancer
A Phase 1 study testing NG11-2 in people with Oral Mucositis, run by VasoDynamics Ltd at 4 sites in United Kingdom.
Trial summary
This study is looking at a new medication called NG11-2 to see if it can reduce a side effect called severe Radiation-induced Oral Mucositis (RIOM) that can happen to people getting radiation treatment for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- NG11-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 22 May 2023to 20 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female head and neck cancer patients scheduled for radiotherapy, aged 18 or over on day of signing informed consent;
- Histologically confirmed head and neck cancer with or without previous resective surgery, having not been previously treated with radiation therapy
- Scheduled to receive a mean radiation dose of no less than 30 Gy on either (a) Extended Oral Cavity, or (b) Buccal Mucosa, or (c) Lips, according to CT-based delineation of Organ-At-Risk (OAR) Guideline, with or without concurrent chemotherapy (Section 13.8 for guidance);
- Rendered dentally fit for radiotherapy;
- Have a Performance Status >60 on the Karnofsky scale
- No evidence of active systemic infections at the time of screening;
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- No oral fungal infection by visual examination or swab test;
- Body Mass Index >=18.5 kg/m²
- Normalcy of diet evaluated with the Performance Status Scale for Head and Neck cancer patients (PSSHN) >=30;
- Ability to retain and swill liquid inside the oral cavity for at least 90 seconds;
- Female patients of childbearing potential must have a negative urine or serum pregnancy test during the 2 week Screening period
- Provide written informed consent for the trial.
- Consent to utilize medically acceptable methods of contraception throughout the study period if of child-bearing potential;
- Be able to comply with protocol procedures (such as Oral Mucositis assessment and swish/spit) and study schedule
Who cannot join
- Tumour of the larynx
- Mentally or legally incapacitated, in the opinion of the PI, which could interfere with the ability of the patient to understand or adhere to the requirements of the study;
- Open or unhealed non-cancerous wounds or ulcers in the oral cavity;
- WHO Oral Mucositis grade of 2 or more
- Uncontrolled Hypertension, defined as blood pressure in adults >150/100mm Hg at screening;
- A known clinically significant abnormal ECG, such as arrhythmia and active ischemia,within 6 months prior to treatment;
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- Xerostomia or hyposalivation;
- Known allergy or intolerance to sympathomimetic drugs (e.g., pseudoephedrine, epinephrine), alcohol, or any NG11-2 excipient;
- Receiving monoamine oxidase (MAO) inhibitors or antidepressants (triptyline or imipramine types); Use of MAO inhibitor in the 14 days prior to treatment, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine;
- History or current evidence of clinically significant laboratory abnormality or any disease condition that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
- Current participation in any other oral mucositis studies or completion/ withdrawal from any other oral mucositis studies within the last 3 months
- Patient is, at the time of signing informed consent, a regular user of any illicit drugs, which would interfere with cooperation with the requirements of the trial;
- Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study;
- Any other condition which, in the opinion of the Investigator, means that the patient is not a good candidate for study enrolment
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Belfast City Hospital
Belfast, BT9 7AB
Queen Elizabeth Hospital
Birmingham, B15 2TH
Guy's & St Thomas' Hospital
London, SE1 9RT
About this study
Official title: A Phase-1b Dose Escalation Study to Assess the Effect of NG11-2 on Radiation Induced Oral Mucositis in Patients With Head & Neck Cancer
This study is looking at a new medication called NG11-2 to see if it can reduce a side effect called severe Radiation-induced Oral Mucositis (RIOM) that can happen to people getting radiation treatment for head and neck cancer. Severe RIOM can make patients very sick and make it hard for them to finish their cancer treatment. Right now, there are no approved drugs that can prevent or treat severe RIOM. This study will test different doses of NG11-2 to find the best one, and then more patients will take that dose to see if it works. This study is being done at multiple hospitals in the UK.
Read the detailed description
The main objective of the trial is to see if the use of NG11-2, when administered as a mouthwash in head and neck cancer patients prior to their radiotherapy, is tolerable and can reduce or prevent the development of severe radiation induced oral mucositis. More specifically, the trial aims to identify an appropriate dose of NG11-2 IMP based on safety and activity/preliminary efficacy for subsequent assessment in follow-up clinical trials.
Although the primary objective of the trial is to evaluate the safety \& tolerability of NG11-2 mouthwash, the secondary objective is to obtain preliminary data on the activity/efficacy of NG11-2 mouthwash in the reduction of severe RIOM.
This is a Phase-1b unblinded, dose escalation, multi-centre study of NG11-2 for the reduction of severe RIOM in Head and Neck cancer patients undergoing radiotherapy, with or without concurrent chemotherapy.
The study design is a "2+4" Dose Escalation design with the following escalation schema (a) If 0 out of 2 enrolled patients have a Dose Limiting Toxicity (DLT) , then escalate to the next Dose Level and enroll 2 more patients (b) if 1 out of 2 patients has a DLT, then add 4 more patients at the same Dose Level (c) if 2 out of 2, or 2 or more out of 6 patients experience a DLT, then stop the dose escalation.
The Maximum Tolerated Dose (MTD) is one dose level below the level at which 2/2 or 2+/6 patients experienced a DLT.
On completion of the Dose Escalation, the Safety Committee will review the available data and a small cohort of patients will be treated at the dose(s) selected by the Safety Committee..
Dosing will start at the 0.92mg/mL (5mM) Dose Level with patients being treated with NG11-2 prior to Radiotherapy on days 1-5 each week for up to 7 weeks.
The proposed patient population for this study includes male and female patients, aged 18 or older with histologically confirmed Head and Neck cancer (preferring oral cavity, oropharyngeal, nasopharyngeal cancer), undergoing primary radical chemoradiotherapy/radiotherapy or adjuvant chemoradiotherapy/radiotherapy with either (a) Extended Oral Cavity, or (b) Buccal Mucosa, or (c) Lips receiving a mean radiation dose of at least 30Gy.
Safety assessments will include evaluation of adverse events (AEs) using NCI CTCAE v5), clinical laboratory assessments (biochemistry, haematology), vital sign measurements (blood pressure, heart rate), 12-lead electrocardiogram (ECG) measurements, and physical examination.
An inspection of the Oral Mucosa will take place every day prior to NG11-2 treatment, except on those days where the Oral Mucositis Scoring Assessment has already occurred, to inspect the condition of the oral mucosa.
The severity of Oral Mucositis (OM) will be scored by trained site staff using WHO, RTOG and NCI-CTCAE v5 scales twice weekly (assessments 72hrs apart) from enrolment to the last study drug treatment, then at weeks 1, 2, 4 and 6 post RT. The WHO scale is the primary scoring scale and the RTOG \& NCI-CTCAE v5 scales are exploratory scoring scales.
Additionally, a Patient Reported Outcome Measure - Oral Mucositis (PROM-OM) questionnaire will be performed at each Oral Mucositis Scoring Assessment.
- Conditions
- Oral Mucositis
- Being tested
- NG11-2
- Keywords
- Oral Mucositis, RIOM, Severe Oral Mucositis
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG11-2Drug
NG11-2 dose level will vary from 0.92 mg/mL to 5.5 mg/mL during the dose escalation process. The NG11-2 is given as an oral rinse.
Throughout the radiotherapy regimen, no more than 60 minutes prior to the completion of radiotherapy, on each weekday the patient will rinse their mouth with 12.5 ml of NG11-2 for between 90 \& 120 seconds duration, gargling twice for approximately three seconds each if possible during this period then expectorate the solution.
| Study group | Role | What they receive |
|---|---|---|
| NG11-2 Treatment | Experimental | Patients will undergo daily treatment with NG11-2 immediately prior to radiotherapy for 5 days/week (Mon-Fri) for up to 7 weeks. Receives: Drug: NG11-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Dose Limiting Toxicities (DLT)
Measured: Dose Limiting Toxicities will be evaluated throughout the study from time of patient consent until 42 days after last IMP dose
Occurence of Serious Adverse Events (SAE)
Measured: Serious Adverse Events will be evaluated throughout the study from time of patient consent until 42 days after last IMP dose
Secondary outcomes (10)
Duration of severe Radiation-Induced Oral Mucositis (World Health Organisation Grade 0-4, higher = worse)
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Duration of severe Radiation-Induced Oral Mucositis (Radiation Therapy Oncology Group Grade 0-4, higher = worse)
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Duration of severe Radiation-Induced Oral Mucositis (National Cancer Institute - Common Toxicity Criteria for Adverse Events V5 Grade 1-5, higher = worse)
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Incidence of severe Radiation-Induced Oral Mucositis (World Health Organisation Grade 0-4, higher = worse
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Incidence of severe Radiation-Induced Oral Mucositis (Radiation Therapy Oncology Group Grade 0-4, higher = worse)
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Incidence of severe Radiation-Induced Oral Mucositis (National Cancer Institute - Common Toxicity Criteria for Adverse Events V5 Grade 1-5, higher = worse)
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Time to onset of severe Radiation-Induced Oral Mucositis (World Health Organisation Grade 0-4, higher = worse
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Time to onset of severe Radiation-Induced Oral Mucositis (Radiation Therapy Oncology Group Grade 0-4, higher = worse)
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Time to Onset of severe Radiation-Induced Oral Mucositis (National Cancer Institute - Common Toxicity Criteria for Adverse Events V5 Grade 1-5, higher = worse)
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Impact of Oral Mucositis on patient's oral pain and ability to eat and drink
Patient Reported Outcome Measure - Oral Mucositis (PROM-OM)
Measured: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start22 May 2023
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an unblinded, single-arm study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- VasoDynamics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Mary Lei, Principal investigator, Guy's & St Thomas' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669390
- Sponsor's protocol ID
- NG11-2-P1b
- Other IDs
- 2022-002409-99, 87831050
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-1b Dose Escalation Study to Assess the Effect of NG11-2 on Radiation Induced Oral Mucositis in Patients With Head & Neck Cancer
- ClinicalTrials.gov ID
- NCT06669390
- Acronym / sponsor ID
- NG11-2-P1b
- Conditions
- Oral Mucositis
- Keywords
- Oral Mucositis, RIOM, Severe Oral Mucositis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- VasoDynamics LtdIndustry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 1 Nov 2024 (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 study is looking at a new medication called NG11-2 to see if it can reduce a side effect called severe Radiation-induced Oral Mucositis (RIOM) that can happen to people getting radiation treatment for head and neck cancer. Severe RIOM can make patients very sick and make it hard for them to finish their cancer treatment. Right now, there are no approved drugs that can prevent or treat severe RIOM. This study will test different doses of NG11-2 to find the best one, and then more patients will take that dose to see if it works. This study is being done at multiple hospitals in the UK.
Detailed description
The main objective of the trial is to see if the use of NG11-2, when administered as a mouthwash in head and neck cancer patients prior to their radiotherapy, is tolerable and can reduce or prevent the development of severe radiation induced oral mucositis. More specifically, the trial aims to identify an appropriate dose of NG11-2 IMP based on safety and activity/preliminary efficacy for subsequent assessment in follow-up clinical trials.
Although the primary objective of the trial is to evaluate the safety \& tolerability of NG11-2 mouthwash, the secondary objective is to obtain preliminary data on the activity/efficacy of NG11-2 mouthwash in the reduction of severe RIOM.
This is a Phase-1b unblinded, dose escalation, multi-centre study of NG11-2 for the reduction of severe RIOM in Head and Neck cancer patients undergoing radiotherapy, with or without concurrent chemotherapy.
The study design is a "2+4" Dose Escalation design with the following escalation schema (a) If 0 out of 2 enrolled patients have a Dose Limiting Toxicity (DLT) , then escalate to the next Dose Level and enroll 2 more patients (b) if 1 out of 2 patients has a DLT, then add 4 more patients at the same Dose Level (c) if 2 out of 2, or 2 or more out of 6 patients experience a DLT, then stop the dose escalation.
The Maximum Tolerated Dose (MTD) is one dose level below the level at which 2/2 or 2+/6 patients experienced a DLT.
On completion of the Dose Escalation, the Safety Committee will review the available data and a small cohort of patients will be treated at the dose(s) selected by the Safety Committee..
Dosing will start at the 0.92mg/mL (5mM) Dose Level with patients being treated with NG11-2 prior to Radiotherapy on days 1-5 each week for up to 7 weeks.
The proposed patient population for this study includes male and female patients, aged 18 or older with histologically confirmed Head and Neck cancer (preferring oral cavity, oropharyngeal, nasopharyngeal cancer), undergoing primary radical chemoradiotherapy/radiotherapy or adjuvant chemoradiotherapy/radiotherapy with either (a) Extended Oral Cavity, or (b) Buccal Mucosa, or (c) Lips receiving a mean radiation dose of at least 30Gy.
Safety assessments will include evaluation of adverse events (AEs) using NCI CTCAE v5), clinical laboratory assessments (biochemistry, haematology), vital sign measurements (blood pressure, heart rate), 12-lead electrocardiogram (ECG) measurements, and physical examination.
An inspection of the Oral Mucosa will take place every day prior to NG11-2 treatment, except on those days where the Oral Mucositis Scoring Assessment has already occurred, to inspect the condition of the oral mucosa.
The severity of Oral Mucositis (OM) will be scored by trained site staff using WHO, RTOG and NCI-CTCAE v5 scales twice weekly (assessments 72hrs apart) from enrolment to the last study drug treatment, then at weeks 1, 2, 4 and 6 post RT. The WHO scale is the primary scoring scale and the RTOG \& NCI-CTCAE v5 scales are exploratory scoring scales.
Additionally, a Patient Reported Outcome Measure - Oral Mucositis (PROM-OM) questionnaire will be performed at each Oral Mucositis Scoring Assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an unblinded, single-arm study
| Arm | Type | Receives |
|---|---|---|
| NG11-2 Treatment | Experimental | Drug: NG11-2Patients will undergo daily treatment with NG11-2 immediately prior to radiotherapy for 5 days/week (Mon-Fri) for up to 7 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female head and neck cancer patients scheduled for radiotherapy, aged 18 or over on day of signing informed consent;
- Histologically confirmed head and neck cancer with or without previous resective surgery, having not been previously treated with radiation therapy
- Scheduled to receive a mean radiation dose of no less than 30 Gy on either (a) Extended Oral Cavity, or (b) Buccal Mucosa, or (c) Lips, according to CT-based delineation of Organ-At-Risk (OAR) Guideline, with or without concurrent chemotherapy (Section 13.8 for guidance);
- Rendered dentally fit for radiotherapy;
- Have a Performance Status >60 on the Karnofsky scale
Key exclusion criteria (14 listed)
- Tumour of the larynx
- Mentally or legally incapacitated, in the opinion of the PI, which could interfere with the ability of the patient to understand or adhere to the requirements of the study;
- Open or unhealed non-cancerous wounds or ulcers in the oral cavity;
- WHO Oral Mucositis grade of 2 or more
- Uncontrolled Hypertension, defined as blood pressure in adults >150/100mm Hg at screening;
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 |
|---|---|---|
| NG11-2NG11-2 dose level will vary from 0.92 mg/mL to 5.5 mg/mL during the dose escalation process. The NG11-2 is given as an oral rinse. Throughout the radiotherapy regimen, no more than 60 minutes prior to the completion of radiotherapy, on each weekday the patient will rinse their mouth with 12.5 ml of NG11-2 for between 90 \& 120 seconds duration, gargling twice for approximately three seconds each if possible during this period then expectorate the solution. | Drug | NG11-2 Treatment |
Primary outcome
Occurence of Dose Limiting Toxicities (DLT)
Time frame: Dose Limiting Toxicities will be evaluated throughout the study from time of patient consent until 42 days after last IMP dose
Occurence of Serious Adverse Events (SAE)
Time frame: Serious Adverse Events will be evaluated throughout the study from time of patient consent until 42 days after last IMP dose
10 secondary outcomes
Duration of severe Radiation-Induced Oral Mucositis (World Health Organisation Grade 0-4, higher = worse)
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Duration of severe Radiation-Induced Oral Mucositis (Radiation Therapy Oncology Group Grade 0-4, higher = worse)
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Duration of severe Radiation-Induced Oral Mucositis (National Cancer Institute - Common Toxicity Criteria for Adverse Events V5 Grade 1-5, higher = worse)
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Incidence of severe Radiation-Induced Oral Mucositis (World Health Organisation Grade 0-4, higher = worse
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Incidence of severe Radiation-Induced Oral Mucositis (Radiation Therapy Oncology Group Grade 0-4, higher = worse)
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Incidence of severe Radiation-Induced Oral Mucositis (National Cancer Institute - Common Toxicity Criteria for Adverse Events V5 Grade 1-5, higher = worse)
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Time to onset of severe Radiation-Induced Oral Mucositis (World Health Organisation Grade 0-4, higher = worse
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Time to onset of severe Radiation-Induced Oral Mucositis (Radiation Therapy Oncology Group Grade 0-4, higher = worse)
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Time to Onset of severe Radiation-Induced Oral Mucositis (National Cancer Institute - Common Toxicity Criteria for Adverse Events V5 Grade 1-5, higher = worse)
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Impact of Oral Mucositis on patient's oral pain and ability to eat and drink
Time frame: From screening and twice weekly in each week of study treatment and then at up to 42 days post end of Radiotherapy, in the follow-up period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
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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.
Dr Mary Lei principal investigator
Guy's & St Thomas' Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NG11-2 in people with Oral Mucositis, run by VasoDynamics Ltd at 4 sites in United Kingdom.
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 14 inclusion and 14 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurence of Dose Limiting Toxicities (DLT) (time frame: Dose Limiting Toxicities will be evaluated throughout the study from time of patient consent until 42 days after last IMP dose). The study lists 2 primary outcomes in all. 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 1 Nov 2024.