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Phosphodiesterase Inhibitor

Tadalafil for Astrocytoma

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 within 12 weeks from start of radiation therapy
Awards & highlights

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
  • Astrocytoma
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 12 weeks from start of radiation therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 12 weeks from start of radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Overall survival (OS)
Progression-free survival (PFS)
Rate of severe lymphopenia

Side effects data

From 2017 Phase 4 trial • 635 Patients • NCT02224846
9%
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%
Sleep disorder
1%
Rhinitis
1%
Pharyngitis
1%
Enteritis
1%
Rhinitis allergic
1%
Influenza
1%
Eczema
1%
Diabetes mellitus
1%
Gout
1%
Back pain
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: 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

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,605 Total Patients Enrolled
5 Trials studying Astrocytoma
25 Patients Enrolled for Astrocytoma
Jiayi Huang, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
196 Total Patients Enrolled
1 Trials studying Astrocytoma
12 Patients Enrolled for Astrocytoma
~4 spots leftby Sep 2025
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