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Study of the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Effects of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer

Primary Purpose

Tumors, Neoplasm Metastasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PTK787/ZK 222584 (vatalanib)
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumors focused on measuring Metastatic solid tumors, PTK787/ZK 222584, Vatalanib, Capecitabine, VEGF (vascular endothelial growth factor), Histologically confirmed metastatic solid tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago

Outcomes

Primary Outcome Measures

Safety
Tolerability

Secondary Outcome Measures

Pharmacokinetics

Full Information

First Posted
September 12, 2005
Last Updated
November 18, 2009
Sponsor
Novartis
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00171587
Brief Title
Study of the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Effects of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer
Official Title
A Phase IB, Open-label, Dose-escalating Study of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Bayer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors, Neoplasm Metastasis
Keywords
Metastatic solid tumors, PTK787/ZK 222584, Vatalanib, Capecitabine, VEGF (vascular endothelial growth factor), Histologically confirmed metastatic solid tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PTK787/ZK 222584 (vatalanib)
Primary Outcome Measure Information:
Title
Safety
Title
Tolerability
Secondary Outcome Measure Information:
Title
Pharmacokinetics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Study of the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Effects of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer

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