Cystic Fibrosis - CompletePhase 2TMXNCT07289035
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
A Phase 2 study testing Tamoxifen Citrate 20Mg Tab in people with Cystic Fibrosis - Complete, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate the safety and tolerability of TMX in adults patients with cystic fibrosis who do not have mutations currently eligible for therapy with modulator drugs. The main questions it aims to answer is: . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis - Complete
- What is being tested?
- Tamoxifen Citrate 20Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jan 2026to 31 Dec 2027
- Phase
- Phase 2
- 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
Who may be able to join
- Patients will be included if they meet all the following inclusion criteria at Visit 1:
- Subjects of both sexes, affected by cystic fibrosis, attending the CF Center in Verona
- Patients who do not have mutations currently eligible for therapy with CFTR modulator drugs
- Age 18 years or older
- Predicted forced expiratory volume in 1 second (ppFEV1) ≥ 40% and ≤ 90% (of the predicted value for people of their age, sex, and height) before bronchodilator administration
- Stable routine CF therapy in terms of dose and medication (inhaled antibiotic cycles, bronchodilator, anti-inflammatory, inhaled corticosteroid, physiotherapy technique/schedule) within 28 days prior to Day 1
Show all 12Show fewer
- Clinically stable respiratory disease within 3 weeks before Day 1 (first dose of study drug)
- Subjects able to perform reliable and reproducible pulmonary function test maneuvers
- Subjects able to communicate well with the investigator, understand, and comply with the study requirements
- Female subjects must have a negative serum pregnancy test
- Sexually active subjects able to follow the contraceptive methods defined within the protocol (non-hormonal contraception) during the study and for 2 months after study discontinuation
- Signed informed consent for participation in the study and for the processing of personal data.
Who cannot join
- Patients will be excluded if one or more of the following criteria are met at Visit 1:
- Patients on any CFTR modulator therapy
- Pulmonary exacerbations within 3 weeks before Day 1 (first dose of study drug)
- Changes in therapy for lung disease within 3 weeks before Day 1 (first dose of study drug)
- Family and/or personal history of thromboembolism and thromboembolic conditions up to 1st-degree relatives
- Documented hereditary thrombophilia (hypercoagulability), e.g., protein C, protein S, and antithrombin deficiency; factor V G169A Leiden, prothrombin G20210A (PT20210A), elevated factor VIII levels, hereditary dysfibrinogenemia
Show all 20Show fewer
- History of solid organ or hematopoietic transplant
- History of hypersensitivity to the study drug or drugs of similar chemical classes or any excipients
- History or presence of prolonged QT interval (QTcB > 450 msec)
- History of malignancy in any organ system (other than localized basal cell carcinoma of the skin) in the last 5 years
- Hemoglobin levels < 9.0 g/dl
- Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or that may jeopardize the subject in case of participation in the study
- History of immunodeficiency diseases
- History of drug or alcohol abuse
- History of any disease or condition that, in the investigator's opinion, could confound the study results
- Abnormal liver function, defined as ≥ 3 times the upper limit of normal (ULN) for any of the following: serum aspartate transaminase (AST), serum alanine transaminase (ALT), total bilirubin.
- Presence at baseline visit of endometrial polyps or vaginal symptoms (e.g., blood discharge, spotting, staining)
- Participation in a clinical study where an investigational drug was administered within 30 days prior to enrollment in the study or 5 half-lives of the study drug, whichever is longer
- Female patients who are pregnant or breastfeeding or who wish to become pregnant during the clinical study period and within one month after the end of the study
- Female patients of childbearing potential who do not use adequate contraception. A woman is considered of childbearing potential (WOCBP), i.e., fertile, after menarche and until reaching post-menopause, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as the absence of menstruation for 12 months without an alternative medical cause. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of menstrual cycle, a single FSH measurement is not sufficient.* *Low failure rate contraceptive methods (less than 1% per year) if used consistently, including: some intrauterine devices, abstinence, or vasectomized partner. Contraception must be maintained until 1 month after the last visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
UOC Fibrosi Cistica - AOUI Verona
Verona, Veneto, 37126
About this study
Official title: Exploratory Study to Evaluate the Safety and Tolerability of Tamoxifen Citrate in the Treatment of Cystic Fibrosis in Patients Without Mutations Currently Eligible for Therapy With CFTR Modulator Drugs
The goal of this clinical trial is to evaluate the safety and tolerability of TMX in adults patients with cystic fibrosis who do not have mutations currently eligible for therapy with modulator drugs.
The main questions it aims to answer is:
. What medical problems do participants have when taking drug TMX?
Participants will:
- Take drug TMX every day for 6 months
- Visit the clinic once every 28 days for checkups and tests
Read the detailed description
Normal airways regulate the volume of airway surface liquid (ASL) through the activation of both cyclic adenosine monophosphate (cAMP) and Ca2+-dependent ion channels. In cystic fibrosis, the genetic defect causes a deficiency of cAMP-dependent CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) activity, leading to reduced Cl- and water secretion from airway epithelial cells and the consequent accumulation of mucus, facilitating bacterial and fungal infections. Women with CF have reduced survival compared with men with CF, although the mechanisms underlying this sex-related disadvantage are unknown. Despite the lack of CFTR, CF airways maintain a limited ability to regulate ASL volume, as ATP release, induced by breathing, activates purinergic pathways that increase intracellular Ca2+ concentration to stimulate an alternative Cl- secretion pathway. It has been hypothesized that estrogen might influence this pathway by reducing the ability of airway epithelia to adequately respond to nucleotides. They found that UTP-mediated Cl- secretion was reduced during periovulatory estrogen peaks in both CF and healthy women. Estrogen also inhibited Ca2+ signaling and ASL volume homeostasis in both non-CF and CF airway epithelia by attenuating Ca2+ influx. 17ß-estradiol inhibits the intracellular Ca2+ signaling, thus impairing the activity of calcium-activated chloride channels (CaCC). This suggests that antiestrogens, such as tamoxifen, could be beneficial in the treatment of CF lung diseases because they may increase Cl- secretion in the airways.
It has been demonstrated that TMX can restore CaCC function by inhibiting estrogen signaling. Furthermore, authors showed that TMX can directly activate CaCC regardless of estrogen signaling, therefore generating a significant amount of chloride current.
The results of these experiments indicate that:
- TMX can increase CaCC currents through two mechanisms:
- Indirectly, as an antagonist of the negative effect of 17β-estradiol on the currents
- Directly, regardless of the antiestrogen effect, by acting on CaCC, the alternative chloride transport pathway
- The action of TMX is not affected by the different class of CFTR mutations since it regulates CaCC
- The effect of TMX on CaCC currents is long-lasting and quantitatively significant, superior to the CFTR-dependent currents obtained from the combination of ivacaftor and lumacaftor
- Both women and men can benefit from TMX
- TMX antagonizes the inhibitory action of estradiol E2 on CaCC currents: TMX could counteract the negative effects of estrogens on CaCC currents during the periovulatory period (about 1 week per month) and acts directly on CaCC currents during all remaining days
- It can be used in combination with other therapeutic agents: given the complexity of intracellular trafficking and the short half-life of mutant CFTR proteins, it is conceivable that the currently available CFTR modulators will improve but not cure cystic fibrosis. Therefore, the treatment of cystic fibrosis may require the combination of different therapeutic agents. TMX treatment could be complementary and synergistic with CFTR modulators.
In conclusion, although effective therapies for CF have been already authorized in the European Union, the use of tamoxifen citrate is justified by the current scientific literature and preclinical data. Patients with CF should benefit from this treatment. Importantly, given its mechanism of action, TMX is expected to be beneficial for patients both with F508del CFTR mutation and other rare variants that still remain orphan of therapies. It follows that the European Commission has considered TMX treatment as a possible clinically relevant advantage for patients with CF.
Based on the results emerged from different studies, the European Commission has granted orphan designation (EU/3/17/1877) to GB Pharma S.r.l. for tamoxifen citrate for the treatment of cystic fibrosis.
Primary Objective The study aims to evaluate the safety and tolerability of TMX in patients with cystic fibrosis who do not have mutations currently eligible for therapy with modulator drugs.
Secondary Objectives
The study also aims to evaluate the effects of TMX on:
- lung function
- quality of life
- pulmonary exacerbations
- hospitalizations for pulmonary exacerbations
- antibiotic cycles
- BMI
- sputum microbiology
- sweat test
- Conditions
- Cystic Fibrosis - Complete
- Being tested
- Tamoxifen Citrate 20Mg Tab
- Keywords
- Cystic Fibrosis, Tamoxifen, CaCC
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen Citrate 20Mg TabDrug
Also called TMX
One tablet per day (20 mg/day), in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen citrate | Experimental | Patients will receive TMX 20 mg/day, in the morning. The choice of this dosage is based on pharmacokinetic and pharmacodynamic data in the literature in patients with breast cancer. Based on this scientific evidence, the dose of 20 mg/day is the minimum dose to ensure safety and efficacy of treatment.
Women should start treatment with TMX between 8 and 12 days after the onset of menstruation. A longer screening period to allow for this timing will not be considered a protocol violation. Men will start treatment at V2 (day 1) and continue at home for 24 weeks. After screening, visits will be performed on the first day of TMX administration (baseline) and after 4, 8, 12, 16, and 24 weeks. Patients will discontinue TMX treatment at week 24 and will be followed for an additional 4 weeks for safety evaluation. Receives: Drug: Tamoxifen Citrate 20Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The primary endpoint of this study will be evaluated by calculating between baseline and week 24 the incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) and treatment discontinuation due to AEs. In addition, frequency of specific, indication-relevant adverse events (e.g., thromboembolic events, elevation of liver enzymes, pulmonary exacerbations) and cumulative AE analyses, such as the number of AEs per patient, will be also evaluated.
Measured: Calculating between baseline and week 24
Secondary outcomes (8)
Changes in respiratory function values
The relative change from baseline to week 24 in ppFEV1
Measured: From baseline to week 24
Changes in pulmonary exacerbation
The number of pulmonary exacerbations up to week 24 and the time to the first pulmonary exacerbation up to week 24
Measured: Up to week 24
Changes in hospitalizations
The number of hospitalizations for cystic fibrosis lasting > 24 hours and the time to the first hospitalization for cystic fibrosis
Measured: From baseline to week 24
Changes in quality of life
The absolute change in the respiratory domain score of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) (the more the value increases, the greater the perceived well-being)
Measured: From baseline to week 24
Changes in antibiotic use
- the use of intravenous antibiotics during the study (total number of days of intravenous antibiotics for sino-pulmonary signs and symptoms up to week 24)
- the use of oral antibiotics during the study (total number of days of oral antibiotics for sino-pulmonary signs and symptoms up to week 24)
Measured: Up to week 24
Changes in BMI
Changes in BMI from baseline to week 24
Measured: From baseline to week 24
Changes in sputum microbiology
Changes in sputum microbiology from screening to week 24
Measured: From screening to week 24
Sweat test - Changes in amount of chloride
Changes in the amount of chloride measured with the sweat test
Measured: At the beginning and end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start22 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis - CompleteStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289035
- Sponsor's protocol ID
- CRCFC-TAMOXI063
- Other IDs
- 2024-519657-11-00
- Acronym
- TMX
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Evaluate the Safety and Tolerability of Tamoxifen Citrate in the Treatment of Cystic Fibrosis in Patients Without Mutations Currently Eligible for Therapy With CFTR Modulator Drugs
- ClinicalTrials.gov ID
- NCT07289035
- Acronym / sponsor ID
- TMX / CRCFC-TAMOXI063
- Conditions
- Cystic Fibrosis - Complete
- Keywords
- Cystic Fibrosis, Tamoxifen, CaCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2025 (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.
The goal of this clinical trial is to evaluate the safety and tolerability of TMX in adults patients with cystic fibrosis who do not have mutations currently eligible for therapy with modulator drugs.
The main questions it aims to answer is:
. What medical problems do participants have when taking drug TMX?
Participants will:
- Take drug TMX every day for 6 months
- Visit the clinic once every 28 days for checkups and tests
Detailed description
Normal airways regulate the volume of airway surface liquid (ASL) through the activation of both cyclic adenosine monophosphate (cAMP) and Ca2+-dependent ion channels. In cystic fibrosis, the genetic defect causes a deficiency of cAMP-dependent CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) activity, leading to reduced Cl- and water secretion from airway epithelial cells and the consequent accumulation of mucus, facilitating bacterial and fungal infections. Women with CF have reduced survival compared with men with CF, although the mechanisms underlying this sex-related disadvantage are unknown. Despite the lack of CFTR, CF airways maintain a limited ability to regulate ASL volume, as ATP release, induced by breathing, activates purinergic pathways that increase intracellular Ca2+ concentration to stimulate an alternative Cl- secretion pathway. It has been hypothesized that estrogen might influence this pathway by reducing the ability of airway epithelia to adequately respond to nucleotides. They found that UTP-mediated Cl- secretion was reduced during periovulatory estrogen peaks in both CF and healthy women. Estrogen also inhibited Ca2+ signaling and ASL volume homeostasis in both non-CF and CF airway epithelia by attenuating Ca2+ influx. 17ß-estradiol inhibits the intracellular Ca2+ signaling, thus impairing the activity of calcium-activated chloride channels (CaCC). This suggests that antiestrogens, such as tamoxifen, could be beneficial in the treatment of CF lung diseases because they may increase Cl- secretion in the airways.
It has been demonstrated that TMX can restore CaCC function by inhibiting estrogen signaling. Furthermore, authors showed that TMX can directly activate CaCC regardless of estrogen signaling, therefore generating a significant amount of chloride current.
The results of these experiments indicate that:
- TMX can increase CaCC currents through two mechanisms:
- Indirectly, as an antagonist of the negative effect of 17β-estradiol on the currents
- Directly, regardless of the antiestrogen effect, by acting on CaCC, the alternative chloride transport pathway
- The action of TMX is not affected by the different class of CFTR mutations since it regulates CaCC
- The effect of TMX on CaCC currents is long-lasting and quantitatively significant, superior to the CFTR-dependent currents obtained from the combination of ivacaftor and lumacaftor
- Both women and men can benefit from TMX
- TMX antagonizes the inhibitory action of estradiol E2 on CaCC currents: TMX could counteract the negative effects of estrogens on CaCC currents during the periovulatory period (about 1 week per month) and acts directly on CaCC currents during all remaining days
- It can be used in combination with other therapeutic agents: given the complexity of intracellular trafficking and the short half-life of mutant CFTR proteins, it is conceivable that the currently available CFTR modulators will improve but not cure cystic fibrosis. Therefore, the treatment of cystic fibrosis may require the combination of different therapeutic agents. TMX treatment could be complementary and synergistic with CFTR modulators.
In conclusion, although effective therapies for CF have been already authorized in the European Union, the use of tamoxifen citrate is justified by the current scientific literature and preclinical data. Patients with CF should benefit from this treatment. Importantly, given its mechanism of action, TMX is expected to be beneficial for patients both with F508del CFTR mutation and other rare variants that still remain orphan of therapies. It follows that the European Commission has considered TMX treatment as a possible clinically relevant advantage for patients with CF.
Based on the results emerged from different studies, the European Commission has granted orphan designation (EU/3/17/1877) to GB Pharma S.r.l. for tamoxifen citrate for the treatment of cystic fibrosis.
Primary Objective The study aims to evaluate the safety and tolerability of TMX in patients with cystic fibrosis who do not have mutations currently eligible for therapy with modulator drugs.
Secondary Objectives
The study also aims to evaluate the effects of TMX on:
- lung function
- quality of life
- pulmonary exacerbations
- hospitalizations for pulmonary exacerbations
- antibiotic cycles
- BMI
- sputum microbiology
- sweat test
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen citrate | Experimental | Drug: Tamoxifen Citrate 20Mg TabPatients will receive TMX 20 mg/day, in the morning. The choice of this dosage is based on pharmacokinetic and pharmacodynamic data in the literature in patients with breast cancer. Based on this scientific evidence, the dose of 20 mg/day is the minimum dose to ensure safety and efficacy of treatment. Women should start treatment with TMX between 8 and 12 days after the onset of menstruation. A longer screening period to allow for this timing will not be considered a protocol violation. Men will start treatment at V2 (day 1) and continue at home for 24 weeks. After screening, visits will be performed on the first day of TMX administration (baseline) and after 4, 8, 12, 16, and 24 weeks. Patients will discontinue TMX treatment at week 24 and will be followed for an additional 4 weeks for safety evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects of both sexes, affected by cystic fibrosis, attending the CF Center in Verona
- Patients who do not have mutations currently eligible for therapy with CFTR modulator drugs
- Age 18 years or older
- Predicted forced expiratory volume in 1 second (ppFEV1) ≥ 40% and ≤ 90% (of the predicted value for people of their age, sex, and height) before bronchodilator administration
- Stable routine CF therapy in terms of dose and medication (inhaled antibiotic cycles, bronchodilator, anti-inflammatory, inhaled corticosteroid, physiotherapy technique/schedule) within 28 days prior to Day 1
Key exclusion criteria (20 listed)
- Patients on any CFTR modulator therapy
- Pulmonary exacerbations within 3 weeks before Day 1 (first dose of study drug)
- Changes in therapy for lung disease within 3 weeks before Day 1 (first dose of study drug)
- Family and/or personal history of thromboembolism and thromboembolic conditions up to 1st-degree relatives
- Documented hereditary thrombophilia (hypercoagulability), e.g., protein C, protein S, and antithrombin deficiency; factor V G169A Leiden, prothrombin G20210A (PT20210A), elevated factor VIII levels, hereditary dysfibrinogenemia
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 |
|---|---|---|
| Tamoxifen Citrate 20Mg TabAlso: TMXOne tablet per day (20 mg/day), in the morning. | Drug | Tamoxifen citrate |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Calculating between baseline and week 24
The primary endpoint of this study will be evaluated by calculating between baseline and week 24 the incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) and treatment discontinuation due to AEs. In addition, frequency of specific, indication-relevant adverse events (e.g., thromboembolic events, elevation of liver enzymes, pulmonary exacerbations) and cumulative AE analyses, such as the number of AEs per patient, will be also evaluated.
8 secondary outcomes
Changes in respiratory function values
Time frame: From baseline to week 24
Changes in pulmonary exacerbation
Time frame: Up to week 24
Changes in hospitalizations
Time frame: From baseline to week 24
Changes in quality of life
Time frame: From baseline to week 24
Changes in antibiotic use
Time frame: Up to week 24
Changes in BMI
Time frame: From baseline to week 24
Changes in sputum microbiology
Time frame: From screening to week 24
Sweat test - Changes in amount of chloride
Time frame: At the beginning and end of the study
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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 Phase 2 study testing Tamoxifen Citrate 20Mg Tab in people with Cystic Fibrosis - Complete, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 12 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 Italy. 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?
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 Marco Cipolli, MD (+390458122293, marco.cipolli@aovr.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Calculating between baseline and week 24). 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 5 Nov 2026.