Cystic Fibrosis - Complete study: Tamoxifen Citrate
Official title Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
ClinicalTrials.gov ID: NCT07289035
What this study is testing
What is Tamoxifen Citrate 20Mg Tab?
Tamoxifen Citrate 20Mg Tab is an investigational medicine, taken by mouth, being studied as a potential treatment for cystic fibrosis - complete.
Also referred to as TMX.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to look at how safe it is of TMX in adults patients with cystic fibrosis who do not have mutations currently eligible for therapy with modulator drugs.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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...
- Stable routine CF therapy in terms of dose and medication (inhaled antibiotic cycles, bronchodilator, anti-inflammatory, inhaled corticosteroid...
You likely can't join if
- 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
- History of solid organ or hematopoietic transplant
See the full eligibility criteria
- people 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
- Clinically stable respiratory disease within 3 weeks before Day 1 (first dose of study drug)
- people able to perform reliable and reproducible pulmonary function test maneuvers
- people able to communicate well with the investigator, understand, and comply with the study requirements
- Female people must have a negative serum pregnancy test
- Sexually active people 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.
- 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Verona, Veneto, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Verona, Veneto, Italy. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.