Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments everolimus (rad 001), placebo
Phase phase 2
Targets mTOR, FKBP-12
Sponsor University of Chicago
Collaborator Novartis Pharmaceuticals
Start date April 2010
End date December 2016
Trial size 160 participants
Trial identifier NCT01111058, 09-266-B

Summary

Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Subjects will receive Everolimus
everolimus (rad 001)
10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).
(Experimental)
Subjects will receive placebo
placebo

Primary Outcomes

Measure
2 year Tumor Progression free survival
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of Squamous cell carcinoma of the head and neck (stage IVa or IVb). No evidence (absence)of disease by scan. - 18 years or older. - Performance status 70% or better. - Adequate marrow, renal and liver function (will be tested by labs). _ Able give consent. Exclusion Criteria: - Currently receiving anti-cancer treatment. - Major surgery or traumatic injury within 4 weeks. - Radiotherapy related toxicities. - Lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors - Receiving other investigational drugs. - Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. - Receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this . - Show evidence of disease (cancer). - Uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function. - Liver disease such as cirrhosis, severe hepatic impairment, Hepatitis B or C. - Active, uncontrolled severe infections - Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. - Known History of HIV positivity. - Impaired gastrointestinal function that may alter absorption of Everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection. - Patients with an active, bleeding diathesis. - Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. ) - Male patient whose sexual partner(s) are Women of child bearing potential who are not willing to use adequate. contraception, during the study and for 8 weeks after the end of treatment - Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus). - Patients with a known hypersensitivity to Everolimus or other rapamycin analogues (sirolimus, temsirolimus) or to its excipients. - History of noncompliance to medical regimens. - Patients unwilling to or unable to comply with the protocol.

Additional Information

Official title Randomized Phase II Trial of Everolimus Versus Placebo as Adjuvant Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
Principal investigator Tanguy Seiwert, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Chicago.