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Tadalafil + Chemotherapy for Stomach Cancer
Phase 2
Recruiting
Led By Junaid Arshad, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Study Summary
This trial aims to assess the effect of combining Tadalafil with chemotherapy before surgery to remove tumors in patients with gastric/gastroesophageal junction adenocarcinoma. Tumor tissue, blood, urine & saliva will be collected.
Who is the study for?
Adults with resectable gastric or gastroesophageal junction adenocarcinoma, who haven't had prior treatments for their cancer. They must have a certain level of albumin in the blood, measurable disease by scans, and adequate organ function. Participants should not be pregnant or breastfeeding and must agree to use contraception during the study and for six months after.Check my eligibility
What is being tested?
The trial is testing Tadalafil's effect on immune cells in the tumor environment when given alone and alongside standard chemotherapy (FLOT) before surgery. Patients will take Tadalafil for two weeks then combine it with FLOT for eight weeks, aiming to reduce suppressor cells that can hinder anti-cancer responses.See study design
What are the potential side effects?
Tadalafil may cause headaches, indigestion, back pain, muscle aches, flushing, stuffy or runny nose. The combination with chemotherapy could add side effects like nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
Pathological response after PDE5 inhibition and treatment using Becker's Criteria
Radiographic response after PDE5 inhibition and treatment based on RECIST1.1
Other outcome measures
Change in PBMCs biomarkers MIR130b before and after treatment.
Change in PBMCs biomarkers SLFN12L before and after treatment.
Change in intrinsic genetic biomarker MIR130b before and after treatment.
+11 moreSide effects data
From 2017 Phase 4 trial • 635 Patients • NCT022248469%
Viral upper respiratory tract infection
3%
Periodontitis
3%
Prostatitis
2%
Alanine aminotransferase increased
2%
Upper respiratory tract infection
2%
Abdominal pain upper
2%
Chronic gastritis
2%
Blood uric acid increased
2%
Insomnia
1%
Eczema
1%
Gout
1%
Back pain
1%
Rhinitis
1%
Sleep disorder
1%
Rhinitis allergic
1%
Pharyngitis
1%
Influenza
1%
Diabetes mellitus
1%
Enteritis
1%
Gastritis
1%
Urinary tract infection
1%
Dizziness
1%
Epistaxis
1%
Renal cyst
1%
Gastric polyps
1%
Gastrooesophageal reflux disease
1%
Nephrolithiasis
1%
Hypertension
1%
Pyrexia
1%
Large intestine polyp
1%
Abdominal distension
1%
Abdominal pain
1%
Dental caries
1%
Diarrhoea
1%
Gamma-glutamyltransferase increased
1%
Headache
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
2.5 mg/5 mg Tadalafil
5 mg Tadalafil
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tadalafil + chemotherapyExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadalafil 20 MG
2019
Completed Phase 3
~200
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,584 Total Patients Enrolled
Junaid Arshad, MDPrincipal InvestigatorUniversity of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the early to mid stages and is located in my stomach or the junction connecting my stomach and esophagus.I have received treatment for stomach cancer before.I haven't taken Tadalafil or similar drugs in the last 28 days.My cancer has spread to other parts of my body.My cancer can be measured on scans taken within the last 28 days.I am not taking nitrates, α-blockers, or similar medications.I do not have any other cancer that needs treatment.I am fully active and can carry on all my pre-disease activities without restriction.I currently have or recently had a COVID-19 infection.I have symptoms of underactive thyroid that aren't treated.I have a serious wound, ulcer, or bone fracture that isn’t healing.I cannot swallow pills.I have a history of HIV/AIDS or tested positive for tuberculosis.My recent tests show my organs and bone marrow are functioning well.I am 18 years old or older.My liver is not working well.I have not had major surgery in the last 2 weeks.I am currently on medication for an infection.I haven't taken any immunosuppressive drugs in the last 2 weeks.I do not have any major ongoing health issues like heart disease or autoimmune disorders.I am not pregnant and can become pregnant based on specific criteria.I have had an episode of vision loss due to optic nerve damage.
Research Study Groups:
This trial has the following groups:- Group 1: Tadalafil + chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Tadalafil in combination with chemotherapy?
"With prior data confirming the safety of Tadalafil + chemotherapy, but no clinical evidence for efficacy yet, our team gave this combination treatment a rating of 2."
Answered by AI
Are any participants being accepted for this research study at present?
"This trial, which was initially posted on March 1st 2023 and most recently edited on February 1st has ceased actively seeking out individuals. According to clinicaltrials.gov, however, there are 783 medical trials still recruiting patients in this moment."
Answered by AI
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