Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer

SCRI Development Innovations

Status and phase

Completed

Phase 2

Phase 1

Conditions

Kidney Cancer

Treatments

Drug: RAD001

Drug: Sorafenib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00392821

SCRI GU 44

CRAD001C2480

Details and patient eligibility

About

This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer.

Participants will be asked to keep a pill diary.

Full description

The drugs used in this trial are called targeted drugs as they target specific activities that are carried out by cancer cells that make them grow and spread. Sorafenib is an approved drug for the treatment of advanced kidney cancer. RAD001 is an experimental drug that has been used in other research studies with other types of cancer. In this trial, the use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental. In the Phase I portion of this study 13-16 patients will be treated with the same dose of sorafenib and different doses of RAD001. The purpose is to see what is a safe dose of RAD001 when combined with sorafenib in the treatment of kidney cancer. Once this dose of RAD001 is determined, about 65 more patients will be treated to see how effective this combination of drugs is against this kidney cancer.

Both of these drugs are taken by mouth. Sorafenib will be taken twice a day. RAD001 is taken by mouth weekly. Patients will be able to continue treatment as long as their disease does not worsen or side effects become intolerable.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinically documented metastatic or unresectable locally recurrent clear cell renal carcinoma
Previous removal of kidney except if the size of the tumor was less than 5 cm or there was extensive liver or bone metastasis
May have had no prior chemotherapy or up to 1 prior treatment regimen with immunotherapy or chemotherapy
Performance status of 0-1
Measurable disease
Adequate liver, renal, and bone marrow function
Must be able to give written informed consent
Women able to become pregnant must have a negative pregnancy test
Must be 18 or over
Must be able to swallow pills

Exclusion criteria

Prior treatment with sorafenib or m-TOR inhibitors
History of acute MI within the last 6 months
Active brain metastasis or patients with meningeal metastases
Prior treatment for another cancer in the last 5 years
Prior bleeding problems; coughing up or vomiting blood
Non-healing wounds, ulcer, or long bone fracture
Chronic use of systemic steroids or immunosuppressive agents
Uncontrolled hypertension

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.