Clareo Health | Study of the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Effects of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer
Study of the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Effects of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
With
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Serum creatinine \<= 1.5 x ULN and 24-hour creatinine clearance \>= 50 ml/min
Total urinary protein in a 24-hour urine collection \<= 500 mg
Life expectancy of greater than 3 months
Written informed consent obtained according to local guidelines
You may not be if
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
Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. Oral, implantable, or injectable contraceptives are not considered an effective method of birth control for this study. (Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of chemotherapy).
Concurrent severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
Acute or chronic liver disease (e.g., hepatitis, cirrhosis)
Confirmed diagnosis of HIV infection
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets)
Patients who are taking Coumadin (warfarin sodium)
Patients unwilling to or unable to comply with the protocol
