A Safety and Dose-finding Study of JNJ-26481585 for Patients With Advanced Solid Malignancies and Lymphoma.

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · May 12, 2008

Keywords

ClinConnect Summary

JNJ-24681585 is a histone deacetylase (HDAC) inhibitor. It is a drug in development for treatment of cancer. In this study, the safety (the effect on the body) of the drug in patients with advanced or refractory solid malignancies or lymphoma will be studied. The maximum dose that can be tolerated by patients will be determined. The absorption, break down, and elimination of the drug will be studied and in some patients the effect of food on these processes will be examined. Antitumor activity of JNJ-26481585 will be evaluated.

JNJ-26481585 will be administered in a continuous regimen with...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective
• • Performance status (based on the Eastern Cooperative Oncology Group assessments) of \<= 2
• • Life expectancy \> 3 months
• • Adequate gastrointestinal absorption status
• • Adequate liver, kidney and bone marrow function
• • Adequate heart function (Left Ventricular Ejection Fraction \>= 50%)
• Exclusion Criteria:
• • Known brain metastases
• • Chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks before study drug administration
• • History of uncontrolled heart disease or uncontrolled arterial hypertension (protocol-defined)
• • Patients taking medications known to have a risk of causing heart function abnormalities (i.e.
• • QTc prolongation and Torsades de Pointes)
• • Neuropathy (malfunction of the nerves) at baseline of Grade \> = 2
• • Positive serology for Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV)