An Open-label, Phase I Study to determine the Safety and Pharmacokinetics of JNJ-26483327, a Multi-targeted Kinase Inhibitor, administered to Subjects with Advanced Stage and/or Refractory Solid Malignancies

An Open-label, Phase I Study to determine the Safety and Pharmacokinetics of JNJ-26483327, a Multi-targeted Kinase Inhibitor, administered to Subjects with Advanced Stage and/or Refractory Solid Malignancies - Dose escalation safety and Pharmacokinetic study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29756

Enrollment

Registered

2006-06-13

Start date

2006-10-26

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male or female, Age 18 years or older, Histologically or cytologically confirmed solid malignancy that is advanced stage and/or refractory and progressing and for which standard treatments do not exist or are no longer effective , ECOG Performance Status 0 - 2, Life expectancy > 3 months.

Exclusion criteria

Exclusion criteria: Known central nervous system metastases, female patient who is pregnant or is breast-feeding, Chemotherapy, radiotherapy, immunotherapy within 4 weeks before dosing with JNJ-26483327, History of uncontrolled heart disease.

Design outcomes

Primary

Measure	Time frame
To determine the safety [(adverse event profile, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)] of JNJ-26483327in male and female subjects with cancer. To determine the pharmacokinetics (PK) of JNJ-26483327 following oral administration in male and female subjects with cancer.	—

Secondary

Measure	Time frame
To monitor the anti-tumor activity of JNJ-26483327 subjects with cancer. To explore pharmacodynamic effects of JNJ-26483327 in skin/tumor biopsies and in blood/serum in subjects with cancer.	—

Countries

Netherlands

Outcome results