Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herbert Hurwitz
• Collaborators: Novartis; Roche-Genentech
• Treatments: Bevacizumab; Capecitabine; Everolimus; Oxaliplatin; Sirolimus

Criteria

Inclusion Criteria:

• Must be 18 years or older

• Must have a performance status of at least 70% (able to carry on most normal activities)

• Must have life expectancy of at least 3 months

• Must have adequate organ and marrow function as determined by lab tests

• Women of child-bearing potential and men must agree to use two forms of contraception

• Ability and willingness to sign a written informed consent document

• Histologically confirmed solid tumor malignancy that is metastatic or unresectable

Exclusion Criteria:

• Pregnant or breastfeeding and/or lactating women

• Patients who have received any other investigational agents within 28 days of the first day of study drug

• Patients with known CNS metastases

• History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer)

• Inadequately controlled hypertension

• Significant vascular disease

• Invasion or encasement of a major artery

• Evidence of bleeding diathesis or coagulopathy

• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study drug

• Serious illness or medical condition

• History of myocardial infarction, unstable angina, cardiac or other vascular stenting

• History of stroke

• HIV, Hepatitis C, Hepatitis B or other serious chronic infection

• Impairment of Gastrointestinal function or disease

• History of interstitial lung disease

• Patients who have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within 28 days of receiving study drug.