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Phosphodiesterase Inhibitor

Tadalafil for Glioblastoma

Phase 1

Waitlist Available

Led By Jiayi Huang, M.D.

Research Sponsored by Washington University School of Medicine

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 baseline through 30 days after last dose of tadalafil (estimated to be 90 days)

Awards & highlights

Study Summary

This trial is testing whether adding the drug tadalafil to standard radiation therapy and temozolomide chemotherapy can improve treatment of patients with a certain type of brain tumor by targeting a type of cell that drives immunosuppression in the tumor.

Eligible Conditions

Glioblastoma
Astrocytoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 30 days after last dose of tadalafil (estimated to be 90 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 30 days after last dose of tadalafil (estimated to be 90 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 30 days after last dose of tadalafil (estimated to be 90 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of adverse events as measured by CTCAE v5.0

Relative change of MDSCs in peripheral blood

Secondary outcome measures

Number of imaging changes on heterogeneity diffusion imaging (HDI)

Overall survival (OS)

Progression-free survival (PFS)

+1 more

Side effects data

From 2017 Phase 4 trial • 635 Patients • NCT02224846

Viral upper respiratory tract infection

Periodontitis

Prostatitis

Alanine aminotransferase increased

Upper respiratory tract infection

Abdominal pain upper

Chronic gastritis

Blood uric acid increased

Insomnia

Eczema

Gout

Back pain

Rhinitis allergic

Rhinitis

Sleep disorder

Pharyngitis

Influenza

Diabetes mellitus

Enteritis

Gastritis

Urinary tract infection

Dizziness

Epistaxis

Renal cyst

Gastric polyps

Gastrooesophageal reflux disease

Nephrolithiasis

Hypertension

Pyrexia

Large intestine polyp

Abdominal distension

Abdominal pain

Dental caries

Diarrhoea

Gamma-glutamyltransferase increased

Headache

Cough

100%

80%

60%

40%

20%

Study treatment Arm

2.5 mg/5 mg Tadalafil

5 mg Tadalafil

Trial Design

1Treatment groups

Experimental Treatment

Group I: TadalafilExperimental Treatment1 Intervention

Tadalafil will be given orally once daily for a total of 60 days at a weight-normalized dose as follows: 10 mg/day if weight ≤63.5 kg 15 mg/day if weight >63.5 kg and ≤104.3 kg 20 mg/day for weight >104.3 kg Standard of care fractionated radiation therapy (RT) to 60 Gy in 30 daily fractions will be administered in this study. Concurrent temozolomide (TMZ) will be administered as per standard of care, i.e., continuously (Monday through Sunday) from Day 1 of RT to the last day of RT at a daily oral dose of 75 mg/m^2 at the discretion of treating medical oncologist. Adjuvant therapy will administered as per standard of care. Typically, this consists of adjuvant TMZ initiated 4 to 6 weeks after completion of RT for 6 cycles at 150-200 mg/m^2 PO per day on Days 1-5 of every 28-day cycle. Tumor-treating fields or Optune device (Novocure) as per routine clinical care during adjuvant TMZ is permitted at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tadalafil

2014

Completed Phase 4

~3280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,691 Total Patients Enrolled

17 Trials studying Glioblastoma

603 Patients Enrolled for Glioblastoma

Jiayi Huang, M.D.Principal InvestigatorWashington University School of Medicine

6 Previous Clinical Trials

196 Total Patients Enrolled

2 Trials studying Glioblastoma

56 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being recruited for this scientific experiment currently?

"According to clinicaltrials.gov, this medical test has stopped enrolling volunteers and is no longer seeking participants. Initially posted on May 14th 2021, the last update made was June 9th 2022; however, 481 other studies are currently inviting patients to join in their trials."

Answered by AI

Has the FDA given approval to Tadalafil?

"Since this is a Phase 1 trial, there is only sparse data to suggest safety and efficacy for Tadalafil. Therefore it was assigned a score of 1 on our rating scale."

Answered by AI

How many participants are involved in this trial?

"This clinical trial is no longer accpeting patients, having been initially posted on May 14th 2021 and lastly updated June 9th 2022. For those seeking alternative trials, 466 studies with glioblastoma are actively recruiting participants while 15 medical experiments looking at Tadalafil are also accepting volunteers."

Answered by AI

Are there any analogous studies that have employed Tadalafil?

"Presently, there are 15 active clinical trials studying the efficacy of Tadalafil with 3 phases in Phase 3. Although most of these studies take place at Shibīn Al Kawm, Menoufia, 189 different medical centres across the world are conducting research on this drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma

2021. "Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04757662.