A Phase IB, Open-label, Dose-escalating Study of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer

Novartis1 site in 1 country22 target enrollmentMay 2002

ConditionsTumors Neoplasm Metastasis

DrugsPTK787/ZK 222584 (vatalanib)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Tumors
Sponsor: Novartis
Enrollment: 22
Locations: 1
Primary Endpoint: Safety
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to assess the safety, tolerability, dose limiting toxicity, and maximum tolerated dose of vatalanib administered orally once daily in combination with capecitabine in patients with advanced cancer. The study is also designed to determine the effect of vatalanib on the pharmacokinetics of capecitabine and the effect of capecitabine on the pharmacokinetics of vatalanib, and to describe the anti-tumor activity of this combination regimen.

Registry

clinicaltrials.gov

Start Date

May 2002

End Date

March 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•Patients with histologically confirmed advanced cancer that is refractory to standard therapy or for which no standard therapy exists (for dose escalation phase of the study only)
•Patients with histologically confirmed metastatic solid tumors or colorectal cancer presenting with metastatic disease and who received up to four prior chemotherapies for metastatic disease (for dose expansion phase of the study only)
•Measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
•Age \>= 18 years old
•Karnofsky Performance Status (KPS) of \>= 70
•Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
•Hemoglobin (Hgb) \>= 9 g/dl
•Platelets \>= 100 x 10\^9/L
•Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \<= 3.0 x upper limit of normal (ULN)
•Serum bilirubin \<= 1.5 x ULN

Exclusion Criteria

•Patients who have acute or chronic leukemias, lymphoma, or multiple myeloma
•Patients who have known bone marrow involvement with tumor
•Patients with a history of primary central nervous system tumors or brain metastases
•Prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant
•Patients who have had more than two prior chemotherapy regimens for metastatic disease (for dose escalation phase of the study only)
•Patients who have received chemotherapy less than 4 weeks (6 weeks for nitrosoureas or mitomycin-C and 2 weeks for vincristine) prior to entry on this study or who have not recovered from side effects of such therapy
•Patients who have received immunotherapy within 2 weeks or who have not recovered from side effects of such therapy
•Patients who have received radiotherapy within 2 weeks or who have not recovered from side effects of such therapy. The site of radiotherapy should not be the only site of measurable disease.
•Major surgery within 2 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy
•Patients who have received investigational drugs within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy