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Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01263951
Recruitment Status : Active, not recruiting
First Posted : December 21, 2010
Last Update Posted : October 26, 2021
Sponsor:
Collaborators:
Bayer
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date  ICMJE November 29, 2010
First Posted Date  ICMJE December 21, 2010
Last Update Posted Date October 26, 2021
Study Start Date  ICMJE November 2010
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
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. [ Time Frame: Every 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
  • To evaluate the secondary endpoints of best response in patients receiving everolimus and sorafenib. [ Time Frame: Every 4 weeks ]
  • To perform correlative scientific studies to determine the relationship between clinical response to everolimus and sorafenib and multiple parameters including the mutational status of BRAF, N-RAS and other relevant cancer genes in the tumor. [ Time Frame: Every 4 weeks ]
  • To investigate the effectiveness of mTOR and Raf kinase inhibition in surrogate tissue and tumor samples. [ Time Frame: Every 4 weeks ]
  • To evaluate the activity of additional signaling pathways in surrogate tissue and tumor samples and explore their relevance to outcome measures. [ Time Frame: Every 4 weeks ]
  • To evaluate the secondary endpoints of time to disease progression in patients receiving everolimus and sorafenib. [ Time Frame: Every 4 weeks ]
  • To evaluate the secondary endpoints of duration of response in patients receiving everolimus and sorafenib. [ Time Frame: Every 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone
Official Title  ICMJE A Phase II Study of Everolimus and Sorafenib in Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Sorafenib Alone
Brief 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.
Detailed Description

The purpose of this research study is to:

  1. Find out if sorafenib and everolimus prevent the growth of tumors that have grown when treated with sorafenib alone
  2. Find out how long one might benefit from treatment with sorafenib and everolimus
  3. Find out what side effects this drug may cause
  4. Measure the amount of sorafenib and everolimus in the blood and see if "markers" can be found to help understand who might benefit from sorafenib and everolimus.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Differentiated Thyroid Cancer
Intervention  ICMJE
  • Drug: Everolimus
    One 5 mg. tablet daily.
    Other Name: Afinitor
  • Drug: Sorafenib
    200 mg. twice daily.
    Other Name: Nexavar
Study Arms  ICMJE Experimental: Everolimus and sorafenib
All patients will receive everolimus and sorafenib daily.
Interventions:
  • Drug: Everolimus
  • Drug: Sorafenib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 7, 2020)
35
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2010)
40
Estimated Study Completion Date  ICMJE May 2022
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of thyroid cancer, that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  • All patients will have been required to have had sorafenib for entry and have had documented progression while on previous treatment with sorafenib.
  • Measurable disease defined as at least one malignant lesion that can be accurately measured on computerized tomography (CT) and/or magnetic resonance imaging (MRI) scan.
  • ECOG performance status < 2.
  • Life expectancy greater than 3 months.
  • Intellectual, emotional, and physical ability to comply with oral medication.

Exclusion Criteria:

  • Restrictions regarding certain prior treatments will apply.
  • Significant medical disease including: uncontrolled congestive heart failure; active symptoms of coronary artery disease, uncontrolled seizure disorder; active infection; uncontrolled diabetes mellitus; requirement for chronic high dose corticosteroid treatment (Topical or inhaled corticosteroids are allowed); requirement for concurrent immunosuppressive drug(s); active autoimmune disease.
  • Organ allografts.
  • Known HIV-infection (HIV testing is not required for participation).
  • Pregnant or breast feeding. Women of childbearing potential and sexually active males must be advised to take precautions to prevent pregnancy during treatment
  • History of second cancer (except adequately treated basal cell or squamous cell skin cancer, in situ treated cervical cancer, colon cancer or melanoma, or any other cancer for which the patient has been disease-free for three or more years).
  • Known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients
  • Use of any experimental therapy within 4 weeks prior to baseline evaluations done prior to enrollment (with the exception of sorafenib which may be continued until treatment start). Therefore, all experimental treatments other than sorafenib must be discontinued 4 weeks prior to baseline studies or enrollment.
  • Patients who did not previously tolerate sorafenib at 200 mg once daily are excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01263951
Other Study ID Numbers  ICMJE UPCC 19309
812004 ( Other Identifier: University of Pennsylvania IRB #1 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not at this time
Current Responsible Party Thomas Jefferson University
Original Responsible Party Marcia Brose, MD PhD, Hospital of the University of Pennsylvania- Abramson Comprehensive Cancer Center
Current Study Sponsor  ICMJE Thomas Jefferson University
Original Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • Bayer
  • Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Marcia Brose, MD, PhD Hospital of the University of Pennsylvania- Abramson Cancer Center
PRS Account Thomas Jefferson University
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP