Gastric AdenocarcinomaPhase 2NCT05709574
Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer
A Phase 2 study testing Tadalafil 20 MG in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by University of Arizona at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the ability of Tadalafil alone and in combination with neoadjuvant FLOT (5-Fluorouracil, Oxaliplatin, and Docetaxel) chemotherapy to suppress myeloid derived suppressor cells (MDSCs) in patients with resectable gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Tadalafil 20 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 30 Oct 2026
- 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
- Stage I-III (T1-3Nx) Gastric or GEJ (Siewert 3) adenocarcinoma, confirmed by histology or cytology.
- Radiographically measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Images (MRI or CT scan) must be completed within 28 days prior to treatment start.
- Age ≥ 18 years.
- Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:
- Absolute neutrophil count (ANC) ≥ 1500/µL without granulocyte colony-stimulating factor support within 2 weeks.
- White blood cell count ≥ 2500/µL including Lymphocyte count ≥ to 500/µL.
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- Platelets ≥ 100,000/µL without transfusion.
- Hemoglobin ≥ 9 g/dL (≥ 90 g/L).
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN) with the following exceptions: Patients with documented liver metastases: AST and ALT ≤ 5 x ULN. Patients with documented liver or bone metastases: ALP ≤ 5 x ULN.
- Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN).
- Serum albumin ≥ 2.8 g/dl.
- (PT)/INR or partial thromboplastin time (PTT) test < 1.3 x the laboratory ULN.
- Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 mL/min using the Cockcroft- Gault equation:
- Males: (140 - age) x weight (kg)/(serum creatinine [mg/dL] × 72)
- Females: [(140 - age) x weight (kg)/(serum creatinine [mg/dL] × 72)] × 0.85
- ECOG performance status ≤ 1.
- Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 6 months after the last dose of study treatment.
- Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes. Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Prior treatment for gastric cancer.
- Prior treatment with Tadalafil or other PDE inhibitors within 28 days.
- Known metastatic disease.
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Cardiovascular disorders: i. Congestive heart failure New York Heart Association Class II-IV, unstable angina pectoris, serious cardiac arrhythmias.
- Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment. iii. Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment. iv. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of study treatment. v. Ventricular tachyarrhythmia requiring ongoing treatment vi. Unstable angina pectoris vii. Sinus bradycardia b) Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: i. The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction. ii. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment. iii. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.
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- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix III for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: i. Rash must cover < 10% of body surface area. ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
- No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
- Active infection requiring systemic treatment with the following exceptions:
- Urinary tract infections.
- HCV on active treatment.
- Patients with SARS-COV-2 infections with the following exceptions:
- Recovery from active symptoms 30 days prior to treatment start.
- Known history of infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or a known positive test for tuberculosis due to tuberculosis infection.
- Concomitant medication uses of nitrates, α-blockers and other interacting medications (CYP3A4 inhibitors and CYP3A4 inductors).
- Other clinically significant disorders as deemed by the investigator, that would preclude safe study participation.
- Serious non-healing wound/ulcer/bone fracture.
- Uncompensated/symptomatic hypothyroidism.
- Moderate to severe hepatic impairment.
- Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
- Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment of within 6 months after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within screening. Test will need to be repeated if last completed >3 days prior to initiation of study treatment.
- Inability to swallow tablets.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Previous episode of Non-arteritic anterior ischemic optic neuropathy (NAION)
- Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at UMC North/University Medical Center
Tucson, Arizona, 85719
About this study
Official title: An Open-Label, Phase II Single-Arm, Window Trial of Tadalafil Effect + Chemotherapy in Patients With Resectable Gastric/GEJ Adenocarcinoma
The goal of this clinical trial is to assess the ability of Tadalafil alone and in combination with neoadjuvant FLOT (5-Fluorouracil, Oxaliplatin, and Docetaxel) chemotherapy to suppress myeloid derived suppressor cells (MDSCs) in patients with resectable gastric or gastroesophageal junction adenocarcinoma. Resectable means the tumor may be removed through surgical intervention. Neoadjuvant chemotherapy is chemotherapy received before the primary course of treatment i.e.surgical intervention.
The main questions it aims to answer are:
Read more
- Is Tadalafil treatment with FLOT feasible and safe?
- How does tadalafil treatment with FLOT affect the tumor microenvironment (TME)?
- Will 8 weeks of neoadjuvant exposure to tadalafil with chemotherapy reduce MDSCs in the TME?
Participants will receive Tadalafil for 14 days followed by combination of Tadalafil + FLOT for approximately 8 weeks as a part of standard of care neoadjuvant treatment in the window between cancer diagnosis and surgical intervention to remove their tumor. Tumor tissue, blood, and urine will be collected at the start of the study, after 2 weeks of treatment with Tadalafil alone, and around the time of surgical intervention. Saliva will also be collected at the start of the study.
Read the detailed description
Despite the availability of multimodality approaches for localized gastric cancer, the survival rates remain dismal for resectable disease. There is a large unmet need to identify new therapeutic options, to be used in combination with chemotherapy and to improve survival outcomes. Emerging data have shown the implication of myeloid derived suppressor cells (MDSCs) in the alteration of tumor microenvironment. The MDSCs are involved in tumor progression by promoting immune suppression, tumor angiogenesis, drug resistance, tumor metastasis and limiting the effects of cancer immunotherapy. In vitro and animal studies have demonstrated that phosphodiesterase 5 inhibitors (PDE5i) such as Sildenafil or Tadalafil inhibit MDSCs, augment the endogenous antitumor immunity and improve the effectiveness of chemotherapy. There have been similar reports of enhanced chemotherapeutic efficacy with PDE5i in murine models of melanoma, multiple myeloma, lung, breast, head and neck, colorectal and brain cancer. PDE5 inhibitors suppress nitric oxide synthetase (Nos)-expressing myeloid derived stem cells (MDSCs). There have been no prior clinical studies using a PDE5,6 inhibitor to enhance chemotherapeutic cell death in the upper gastrointestinal cancers. Therefore, the investigators propose this trial to study the effect of the long-acting PDE5,6i Tadalafil in combination with chemotherapy (FLOT) in resectable Gastric/GEJ cancers.
This is a single arm, phase II, window trial to assess the ability of Tadalafil to suppress MDSCs as monotherapy and in combination with neoadjuvant FLOT chemotherapy in patients with resectable gastric or gastroesophageal junction adenocarcinoma.
The study will enroll 10 patients. Patients will receive Tadalafil for 14 days followed by combination of Tadalafil + FLOT for approximately 8 weeks as a part of standard of care neoadjuvant treatment. Tumor specimens, blood, and urine will be collected at baseline, after 2 weeks of monotherapy treatment with Tadalafil, and around the time of surgical intervention to analyze the tumor microenvironment (TME) and to determine whether PDE5, 6 inhibition reduces the immune suppressive microenvironment. Saliva will also be collected at baseline.
Hypothesis: The investigators hypothesize that daily dosing of Tadalafil with chemotherapy will significantly reduce myeloid-derived suppressor cells (MDSCs) in the TME.
- Being tested
- Tadalafil 20 MG
- Keywords
- PDE5,6i inhibitor, chemotherapeutic cell death, resectable Gastric/GEJ cancer, tadalafil, FLOT chemotherapy, Myeloid Derived Suppressor Cells (MDSCs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 20 MGDrug
Also called Cialis
Tadalafil 20 mg tablets will be taken daily for 2 weeks alone and then for 8 weeks in combination with neoadjuvant chemotherapy in the window between gastric/GEJ adenocarcinoma diagnosis and interventional surgery.
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil + chemotherapy | Experimental | Subjects will receive Tadalafil monotherapy for 2 weeks followed by Tadalafil in combination with neoadjuvant FLOT chemotherapy for 8 weeks in the window between their cancer diagnosis and surgical intervention. Receives: Drug: Tadalafil 20 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the safety and tolerability of tadalafil treatment with FLOT chemotherapy by assessing the number of participants with treatment related adverse events usting CTCAE v. 5.0.
To evaluate the safety and tolerability by assessing the number of participants with treatment related adverse events using CTCAE v5.0.
Measured: 10 weeks
Secondary outcomes (2)
Pathological response after PDE5 inhibition and treatment using Becker's Criteria
To evaluate the pathologic response using Becker's Criteria.
Measured: 10 weeks
Radiographic response after PDE5 inhibition and treatment based on RECIST1.1
To evaluate the radiologic response based on response evaluation criteria in solid tumors version 1.1 (RECIST1.1)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start20 Apr 2023
- Primary completion3 Jun 2026
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junaid Arshad, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709574
- Sponsor's protocol ID
- STUDY00001728
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase II Single-Arm, Window Trial of Tadalafil Effect + Chemotherapy in Patients With Resectable Gastric/GEJ Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05709574
- Acronym / sponsor ID
- STUDY00001728
- Keywords
- PDE5,6i inhibitor, chemotherapeutic cell death, resectable Gastric/GEJ cancer, tadalafil, FLOT chemotherapy, Myeloid Derived Suppressor Cells (MDSCs)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 2 Feb 2023 (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 assess the ability of Tadalafil alone and in combination with neoadjuvant FLOT (5-Fluorouracil, Oxaliplatin, and Docetaxel) chemotherapy to suppress myeloid derived suppressor cells (MDSCs) in patients with resectable gastric or gastroesophageal junction adenocarcinoma. Resectable means the tumor may be removed through surgical intervention. Neoadjuvant chemotherapy is chemotherapy received before the primary course of treatment i.e.surgical intervention.
The main questions it aims to answer are:
- Is Tadalafil treatment with FLOT feasible and safe?
- How does tadalafil treatment with FLOT affect the tumor microenvironment (TME)?
- Will 8 weeks of neoadjuvant exposure to tadalafil with chemotherapy reduce MDSCs in the TME?
Participants will receive Tadalafil for 14 days followed by combination of Tadalafil + FLOT for approximately 8 weeks as a part of standard of care neoadjuvant treatment in the window between cancer diagnosis and surgical intervention to remove their tumor. Tumor tissue, blood, and urine will be collected at the start of the study, after 2 weeks of treatment with Tadalafil alone, and around the time of surgical intervention. Saliva will also be collected at the start of the study.
Detailed description
Despite the availability of multimodality approaches for localized gastric cancer, the survival rates remain dismal for resectable disease. There is a large unmet need to identify new therapeutic options, to be used in combination with chemotherapy and to improve survival outcomes. Emerging data have shown the implication of myeloid derived suppressor cells (MDSCs) in the alteration of tumor microenvironment. The MDSCs are involved in tumor progression by promoting immune suppression, tumor angiogenesis, drug resistance, tumor metastasis and limiting the effects of cancer immunotherapy. In vitro and animal studies have demonstrated that phosphodiesterase 5 inhibitors (PDE5i) such as Sildenafil or Tadalafil inhibit MDSCs, augment the endogenous antitumor immunity and improve the effectiveness of chemotherapy. There have been similar reports of enhanced chemotherapeutic efficacy with PDE5i in murine models of melanoma, multiple myeloma, lung, breast, head and neck, colorectal and brain cancer. PDE5 inhibitors suppress nitric oxide synthetase (Nos)-expressing myeloid derived stem cells (MDSCs). There have been no prior clinical studies using a PDE5,6 inhibitor to enhance chemotherapeutic cell death in the upper gastrointestinal cancers. Therefore, the investigators propose this trial to study the effect of the long-acting PDE5,6i Tadalafil in combination with chemotherapy (FLOT) in resectable Gastric/GEJ cancers.
This is a single arm, phase II, window trial to assess the ability of Tadalafil to suppress MDSCs as monotherapy and in combination with neoadjuvant FLOT chemotherapy in patients with resectable gastric or gastroesophageal junction adenocarcinoma.
The study will enroll 10 patients. Patients will receive Tadalafil for 14 days followed by combination of Tadalafil + FLOT for approximately 8 weeks as a part of standard of care neoadjuvant treatment. Tumor specimens, blood, and urine will be collected at baseline, after 2 weeks of monotherapy treatment with Tadalafil, and around the time of surgical intervention to analyze the tumor microenvironment (TME) and to determine whether PDE5, 6 inhibition reduces the immune suppressive microenvironment. Saliva will also be collected at baseline.
Hypothesis: The investigators hypothesize that daily dosing of Tadalafil with chemotherapy will significantly reduce myeloid-derived suppressor cells (MDSCs) in the TME.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tadalafil + chemotherapy | Experimental | Drug: Tadalafil 20 MGSubjects will receive Tadalafil monotherapy for 2 weeks followed by Tadalafil in combination with neoadjuvant FLOT chemotherapy for 8 weeks in the window between their cancer diagnosis and surgical intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Stage I-III (T1-3Nx) Gastric or GEJ (Siewert 3) adenocarcinoma, confirmed by histology or cytology.
- Radiographically measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Images (MRI or CT scan) must be completed within 28 days prior to treatment start.
- Age ≥ 18 years.
- Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:
- ECOG performance status ≤ 1.
Key exclusion criteria (31 listed)
- Prior treatment for gastric cancer.
- Prior treatment with Tadalafil or other PDE inhibitors within 28 days.
- Known metastatic disease.
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix III for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:
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 |
|---|---|---|
| Tadalafil 20 MGAlso: CialisTadalafil 20 mg tablets will be taken daily for 2 weeks alone and then for 8 weeks in combination with neoadjuvant chemotherapy in the window between gastric/GEJ adenocarcinoma diagnosis and interventional surgery. | Drug | Tadalafil + chemotherapy |
Primary outcome
Evaluating the safety and tolerability of tadalafil treatment with FLOT chemotherapy by assessing the number of participants with treatment related adverse events usting CTCAE v. 5.0.
Time frame: 10 weeks
To evaluate the safety and tolerability by assessing the number of participants with treatment related adverse events using CTCAE v5.0.
2 secondary outcomes
Pathological response after PDE5 inhibition and treatment using Becker's Criteria
Time frame: 10 weeks
Radiographic response after PDE5 inhibition and treatment based on RECIST1.1
Time frame: 10 weeks
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 2 Jul 2026.
- 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.
Junaid Arshad, MD principal investigator
University of Arizona
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 Tadalafil 20 MG in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by University of Arizona at 1 site in United States.
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 19 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 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 United States. 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?
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?
Evaluating the safety and tolerability of tadalafil treatment with FLOT chemotherapy by assessing the number of participants with treatment related adverse events usting CTCAE v. 5.0. (time frame: 10 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 2 Jul 2026.