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

NCT01263951 | Unknown Phase 2 DMC

• 2 other identifiers: UPCC 19309812004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Differentiated Thyroid Cancer

Keywords

Differentiated metastatic thyroid cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Every 4 weeks

Secondary Outcomes (6)

• To evaluate the secondary endpoints of best response in patients receiving everolimus and sorafenib.

  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.

  Every 4 weeks

• To investigate the effectiveness of mTOR and Raf kinase inhibition in surrogate tissue and tumor samples.

  Every 4 weeks

• To evaluate the activity of additional signaling pathways in surrogate tissue and tumor samples and explore their relevance to outcome measures.

  Every 4 weeks

• To evaluate the secondary endpoints of time to disease progression in patients receiving everolimus and sorafenib.

  Every 4 weeks

Study Arms (1)

Everolimus and sorafenib

EXPERIMENTAL

All patients will receive everolimus and sorafenib daily.

Drug: Everolimus; Drug: Sorafenib

Interventions

Everolimus DRUG

One 5 mg. tablet daily.

Also known as: Afinitor

Everolimus and sorafenib

Sorafenib DRUG

200 mg. twice daily.

Also known as: Nexavar

Everolimus and sorafenib

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Bayer: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Everolimus; Sorafenib

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Marcia Brose, MD, PhD

  Hospital of the University of Pennsylvania- Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 21, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2021
• Study Completion: May 1, 2022
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)