Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasm Metastases

In brief

The purpose of this study is to test the safety of the combination of two drugs called RAD001 and AMG479. This study will see what effects (good and bad) RAD001 and AMG479 have on cancer. This study will also find the highest doses of RAD001 and AMG479 that can be given without causing severe side effects.

Key facts

Study ID

NCT01122199

Run by

Shadia Jalal

People needed

27

Starts

2010-05-14

Expected to finish

2015-01-19

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological proof of metastatic solid tumor refractory to standard therapies, or for which no standard therapies are available.
• Patients in the expansion cohort must have a measurable site of disease according to RECIST (v 1.0)
• Laboratory values must be obtained within protocol limits and obtained within 14 days prior to registration
• Patients must have disease which is not amenable to potentially curative surgical resection of metastatic disease (curative metastasectomy).
• Must be willing to provide metastatic tissue biopsy samples (may be paraffin embedded) at baseline
• Must be willing to undergo a metastatic tissue biopsy after 2 cycles of therapy to perform pharmacodynamic research biomarkers testing.
• Subjects must be willing and able to abstain from using strong or moderate CYP3A4 inhibitors or inducers during the study period.

You may not qualify if…

• No symptomatic brain metastasis
• No prior treatment with an mTOR inhibitor or with an IGF-1R inhibitor
• No known history of diabetes mellitus
• No thrombosis or vascular ischemic events within the last twelve months
• No chronic treatment with systemic steroids or another immunosuppressive agent
• No active bleeding or a pathological condition that is associated with a high risk of bleeding
• No known history of HIV seropositivity
• No known history of Hepatitis B or Hepatitis C seropositivity
• No known hypersensitivity to AMG 479, RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus), or to its excipients
• No planned immunization with attenuated live viruses during the study period

Where it is running

• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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