Clinical trial · Interventional
A Safety and Dose-finding Study of JNJ-26481585 for Patients With Advanced Solid Malignancies and Lymphoma.
An Open-Label Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of JNJ-26481585 in Subjects With Advanced Stage and/or Refractory Solid Malignancies and Lymphomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-26481585 | Drug | Quisinostat | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available