Status:
COMPLETED
A Safety and Dose-finding Study of JNJ-26481585 for Patients With Advanced Solid Malignancies and Lymphoma.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Lymphoma
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00677105
Start Date
August 1 2007
End Date
September 1 2011
Last Update
September 17 2012
Active Locations (6)
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1
Glasgow, United Kingdom
2
Leeds, United Kingdom
3
London, United Kingdom
4
Manchester, United Kingdom