Clinical trial · Interventional
A Research Study of JNJ-26854165 to Determine the Safety and Dose in Patients With Advanced Stage or Refractory Solid Tumors.
A Phase I Study to Determine the Safety, Pharmacology, and Pharmacodynamics of JNJ26854165 in Subjects With Advanced Stage and/or Refractory Solid Tumors
NCT00676910CI-TRIAL-00003295completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 JNJ-26854165 (a new drug in development for cancer) in patients with advanced or refractory solid tumors on the maximum dose tolerated by these patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-26854165 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the safety of JNJ-26854165 and the maximum tolerated dose in patients with advanced stage or refractory solid tumors.
Secondary outcomes (1)
- measure
- Determine how JNJ-26854165 is absorbed, broken down and eliminated and the effect of food on these processes. Explore how JNJ-26854165 effects the body and the disease.Determine how JNJ-26854165 interacts with other specific drugs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed solid malignancy, in advanced, incurable stage or not responsive to available therapies * performance status (based on the Eastern Cooperative Oncology Group assessments) of \<= 2 * life expectancy \> 3 months * must consent to skin biopsies * must meet protocol-defined criteria for lab assessments and heart function. Exclusion Criteria: * Known central nervous system metastasis * chemotherapy, radiotherapy, immunotherapy or use of any investigational agent within 2 weeks before dosing * treatment within last 6 months or expected to require treatment with amiodarone derivates during study participation * currently treated and/or expected to require treatment with warfarin/coumarine derivates during study participation * history of uncontrolled heart disease or uncontrolled arterial hypertension * eye abnormality at screening examination * \>70% stenosis of lumen on Carotid duplex assessment at screening.
References
Publications (0)
Data not yet available
No reference posted for this study.