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

NCT00677105 | Completed Phase 1 DMC

• 1 other identifier: CR013924
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Lymphoma; Neoplasms

Keywords

Lymphoma; Neoplasms; Solid Tumors; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Determine the safety and the maximum tolerated dose of JNJ-26481585. Determine how JNJ-26481585 and its metabolite, JNJ-26395018, are absorbed, broken down and eliminated after oral administration

Secondary Outcomes (1)

• Investigate the effect of food on the absorption, break down and elimination of JNJ-26481585 and its metabolite, JNJ-26395018. Monitor the antitumor activity of JNJ-26481585.

Interventions

JNJ-26481585 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Janssen Pharmaceutica N.V., Belgium: collaborator

Study Sites (6)

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Leeds, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Newcastel Upon Tyne, United Kingdom

Location

Unknown Facility

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Neoplasms

Interventions

quisinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 13, 2008
• Study Start: August 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

GB (6)