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mTOR inhibitor
Sorafenib for Thyroid Cancer
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 every 4 weeks
Awards & highlights
Study Summary
This study is evaluating whether a drug combination can improve the survival of people with metastatic differentiated thyroid cancer.
Eligible Conditions
- Thyroid Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the efficacy of everolimus and sorafenib (progression free survival, objective response rate and stable disease) in patients with advanced differentiated thyroid cancer who have progressed on sorafenib alone.
Secondary outcome measures
To evaluate the activity of additional signaling pathways in surrogate tissue and tumor samples and explore their relevance to outcome measures.
To evaluate the secondary endpoints of best response in patients receiving everolimus and sorafenib.
To evaluate the secondary endpoints of duration of response in patients receiving everolimus and sorafenib.
+3 moreSide effects data
From 2020 Phase 2 trial • 40 Patients • NCT0190000212%
AST increase
12%
Hypertension
9%
Hyponatremia
9%
Fatigue
6%
Vomiting
6%
Nausea
6%
Dizziness
6%
Diarrhea
6%
ALT increase
3%
Weight Loss
3%
Hypertenstion
3%
Duodenal Ulcer
3%
Sepsis
3%
Acute Renal Failure
3%
Hypotension
3%
Hypophosphatemia
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
3%
Mucositis
3%
Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Sorafenib Tosylate, TheraSphere)
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
105,009 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,954 Total Patients Enrolled
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,742 Total Patients Enrolled
Frequently Asked Questions
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