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mTOR inhibitor
Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone
Phase 2
Waitlist Available
Led By Marcia Brose, MD, PhD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
The goal of this study is to determine the effect of combining everolimus and sorafenib in patients with metastatic differentiated thyroid cancer who progressed on sorafenib alone.
Eligible Conditions
- Thyroid Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2020 Phase 2 trial • 40 Patients • NCT0190000212%
AST increase
12%
Hypertension
9%
Hyponatremia
9%
Fatigue
6%
ALT increase
6%
Vomiting
6%
Nausea
6%
Dizziness
6%
Diarrhea
3%
Hypophosphatemia
3%
Mucositis
3%
Encephalopathy
3%
Weight Loss
3%
Hypertenstion
3%
Duodenal Ulcer
3%
Sepsis
3%
Acute Renal Failure
3%
Hypotension
3%
Hematuria
3%
Hepatic Hemorrhage
3%
Urinary Retention
3%
Dyspnea
3%
Weakness
3%
Abdominal Pain
3%
Rectal Bleed
3%
Palmar-Planta Erythrodysesthesia
3%
Thrombocytopenia
3%
Hyperbilirubinemia
3%
Proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Sorafenib Tosylate, TheraSphere)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Everolimus and sorafenibExperimental Treatment2 Interventions
All patients will receive everolimus and sorafenib daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
FDA approved
Sorafenib
FDA approved
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,450 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
465 Previous Clinical Trials
176,817 Total Patients Enrolled
BayerIndustry Sponsor
2,276 Previous Clinical Trials
25,540,676 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,918 Previous Clinical Trials
4,254,288 Total Patients Enrolled
Marcia Brose, MD, PhDPrincipal InvestigatorHospital of the University of Pennsylvania- Abramson Cancer Center
3 Previous Clinical Trials
48 Total Patients Enrolled