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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety of the drug (JNJ-24681585 a drug in development for cancer) in patients with advanced or refractory solid malignancies or lymphoma on the maximum dose that can be tolerated by these patients. The absorption, breakdown and elimination of the drug will be studied and in some patients, the effect of the food on these processes will also be examined.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Janssen Pharmaceutica N.V., Belgium

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)