TumorsPhase 1/2NCT00171587
Study of the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Effects of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer
A Phase 1/2 study testing PTK787/ZK 222584 (vatalanib) in people with Tumors and Neoplasm Metastasis, run by Novartis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors, Neoplasm Metastasis
- What is being tested?
- PTK787/ZK 222584 (vatalanib)
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Mar 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IB, Open-label, Dose-escalating Study of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer
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.
- Conditions
- Tumors, Neoplasm Metastasis
- Being tested
- PTK787/ZK 222584 (vatalanib)
- Keywords
- Metastatic solid tumors, PTK787/ZK 222584, Vatalanib, Capecitabine, VEGF (vascular endothelial growth factor), Histologically confirmed metastatic solid tumors
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTK787/ZK 222584 (vatalanib)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Tolerability
Secondary outcomes (1)
Pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171587
- Sponsor's protocol ID
- CPTK787 0134/306220
- Status last verified
- Nov 2009
- First submitted
- 12 Sep 2005
- Last updated
- 19 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB, Open-label, Dose-escalating Study of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00171587
- Acronym / sponsor ID
- CPTK787 0134/306220
- Conditions
- Tumors, Neoplasm Metastasis
- Keywords
- Metastatic solid tumors, PTK787/ZK 222584, Vatalanib, Capecitabine, VEGF (vascular endothelial growth factor), Histologically confirmed metastatic solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- May 2002
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTK787/ZK 222584 (vatalanib) | Drug | – |
Primary outcome
Safety
Tolerability
1 secondary outcome
Pharmacokinetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis study chair
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PTK787/ZK 222584 (vatalanib) in people with Tumors and Neoplasm Metastasis, run by Novartis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2009.