Pharmacokinetics Clinical Trial
Official title:
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
The purpose of this study is to assess JNJ-26483327 (a drug in development for cancer) for the safety of the drug in patients with advanced solid tumors that have not responded or are no longer responding to available therapies. The absorption, breakdown and elimination of the drug will also be studied.
Status | Completed |
Enrollment | 19 |
Est. completion date | July 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Confirmed diagnosis of solid malignancy that is advanced or refractory and progressing and for which standard treatments do not exist or are no longer effective - radiological assessment of disease within 4 weeks of first study drug administration - overall health status as determined by the Eastern Cooperative Oncology Group (ECOG) < = 2 - life expectancy > 3 months - adequate gastrointestinal absorption and ability to swallow - left ventricular ejection fraction (LVEF) > 50% and protocol-defined criteria for laboratory tests. Exclusion Criteria: - Cancer has spread to the central nervous system - chemotherapy, radiotherapy, immunotherapy within 4 weeks before study drug administration or incomplete recovery from preceding surgery or toxicity of prior anticancer therapy (excluding peripheral neuropathy and alopecia) - history of uncontrolled heart disease as defined in the protocol - history of pulmonary fibrosis - acute infection requiring systemic therapy. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Janssen Pharmaceutica N.V., Belgium |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the safety (effects on the body) and the maximum tolerated dose of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 taken by patients as an oral capsule is absorbed, broken down and eliminated. | |||
Secondary | Assess the anti-cancer activity of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 works in patients with cancer. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04092725 -
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04181008 -
Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
|
Early Phase 1 | |
Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
Completed |
NCT04406415 -
Oral Nafamostat in Healthy Volunteers
|
Phase 1 | |
Not yet recruiting |
NCT05421312 -
Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip
|
Phase 4 | |
Completed |
NCT02534753 -
A Pharmacokinetics Study of Intravenous Ascorbic Acid
|
Phase 1 | |
Completed |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
Completed |
NCT01682408 -
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
|
Phase 1 | |
Completed |
NCT01976078 -
Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents
|
N/A | |
Completed |
NCT01214941 -
Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
|
Phase 4 | |
Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
Completed |
NCT01208155 -
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
|
Phase 1 | |
Completed |
NCT01260025 -
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
|
Phase 1 | |
Completed |
NCT00984009 -
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
|
Phase 1 | |
Completed |
NCT00983242 -
Drug-Drug Interaction Between Colchicine and Verapamil ER
|
Phase 1 | |
Completed |
NCT00746499 -
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
|
Phase 1 | |
Completed |
NCT00856570 -
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
|
Phase 1 | |
Completed |
NCT00747721 -
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
|
Phase 1 | |
Completed |
NCT01055964 -
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
|
Phase 3 | |
Completed |
NCT01276119 -
The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
|
Phase 1 |