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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Tumors, Neoplasm Metastasis

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Trial Information

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


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

- 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

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

- 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

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Principal Investigator

Novartis

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis

Authority:

United States: Food and Drug Administration

Study ID:

CPTK787 0134/306220

NCT ID:

NCT00171587

Start Date:

May 2002

Completion Date:

March 2007

Related Keywords:

  • Tumors
  • Neoplasm Metastasis
  • Metastatic solid tumors
  • PTK787/ZK 222584
  • Vatalanib
  • Capecitabine
  • VEGF (vascular endothelial growth factor)
  • Histologically confirmed metastatic solid tumors
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

University of Chicago Chicago, Illinois  60637