A Phase I Trial of ABT-263 (Navitoclax), a Bcl-2 inhibitor, and Sorafenib (Nexavar) in Patients with Relapsed or Refractory Solid Organ Tumors

Protocol: 
AAAQ9684
Phase: 
I

A Phase I Trial of ABT-263 (Navitoclax), a Bcl-2 inhibitor, and Sorafenib (Nexavar) in Patients with Relapsed or Refractory Solid Organ Tumors

This study is testing the Addition of Oral Navitoclax Combined with Approved Oral Systemic Therapy (Sorafenib) in Advanced Cancer Tumors. The purpose of this study is to test the safety of a study drug called naviltoclax in combination with sorafenib to find out what effects if any, it has on people.There will be about 44 people taking part in this study.

Are you Eligible? (Inclusion Criteria)

-Known cirrhosis or chronic HBV or HCV infection,
-Hypervascular liver masses > 2 cm, and either serum alpha fetoprotein (AFP)
> 400 ng/ml,
-AFP > three times normal and doubling in value in the antecedent 3 months.
- In the expansion cohort, prior treatment with sorafenib as first-line
therapy allowed.