Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00091299
Warfarin and Vatalanib in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing warfarin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Vatalanib may stop the growth of tumor cells by stopping blood flow to the tumor. Warfarin may be effective in preventing the formation of blood clots in patients who are undergoing treatment for advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Aug 2012
- Phase
- Phase 1
- 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
- Histologically confirmed advanced solid tumor
- Progressed despite standard therapy OR no known standard therapy exists
- -- Currently receiving OR a candidate for prophylactic low-dose warfarin (1 mg/day)
- INR ≤ 1.4
- Must be an extensive metabolizer of CYP2C9 (at least 1 wild type allelle: *1)
- 18 and over
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- Hemoglobin ≥ 9 g/dL
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Albumin ≥ 3.0 g/dL
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- Creatinine ≤ 1.5 ULN OR
- Creatinine clearance > 50 mL/min
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- More than 14 days since prior anticancer chemotherapy
- More than 14 days since prior anticancer hormonal therapy
- More than 14 days since prior anticancer radiotherapy
- More than 14 days since other prior anticancer therapy
- More than 30 days since prior investigational drugs
- No ethanol for 2 days prior to and for the first 17 days of study treatment
Who cannot join
- No poor metabolizers of CYP2C9 (2 alleles of either *2 or *3)
- brain metastases
- history of or active coagulation disorders
- significant risk for bleeding
- uncontrolled high blood pressure (BP), defined as diastolic BP > 90 mm Hg or systolic BP > 140 mm Hg
- history of cerebral or aortic aneurysm
Show all 18Show fewer
- pregnant or nursing
- recent history or evidence of drug or alcohol abuse
- active peptic ulcer disease or gastrointestinal bleeding
- contraindication or allergy to warfarin or related compounds
- risk for adverse events related to prolonged PT/PTT due to warfarin administration
- other medical condition that would preclude study participation
- concurrent chemotherapy
- concurrent hormonal therapy
- concurrent radiotherapy
- other concurrent CYP2C9 substrates or inhibitors
- concurrent CYP3A4 inducers or inhibitors
- concurrent food or dietary supplement known to alter the metabolism of CYP3A4 (e.g., grapefruit or Hypericum perforatum [St. John's wort])
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-7187
About this study
Official title: An Open Label, Non Randomized , One Sequence, Add-On Study to Investigate the Effects of PTK787/ZK 222584 on the Pharmacokinetics and Pharmacodynamics of Warfarin at Steady-States in Cancer Patients
RATIONALE: Vatalanib may stop the growth of tumor cells by stopping blood flow to the tumor. Warfarin may be effective in preventing the formation of blood clots in patients who are undergoing treatment for advanced solid tumors.
PURPOSE: This phase I trial is studying how well giving warfarin together with vatalanib works in treating patients with advanced solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the acute and chronic changes in INR in patients with advanced solid tumors treated with low-dose warfarin and vatalanib.
Secondary
- Determine the steady-state pharmacokinetics of this regimen in these patients.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
- Pharmacokinetic (PK) phase: Patients receive oral low-dose warfarin once daily on days 1-14 and oral vatalanib once daily, 1 hour before warfarin administration, on days 2-14 in the absence of disease progression or unacceptable toxicity.
- Continuation phase: Patients not experiencing a drug interaction in the PK phase continue to receive oral vatalanib and oral low-dose warfarin once daily. Patients experiencing a drug interaction (INR > 2.0) in the PK phase receive oral vatalanib alone once daily. Continuation therapy continues indefinitely in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Being tested
- warfarin
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarinDrug
| Study group | Role | What they receive |
|---|---|---|
| warfarin | Experimental | Not described Receives: Drug: warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate acute and chronic changes in INR when Warfarin is co-administered with PTK787/ZK 222584
Measured: 2 weeks
Secondary outcomes (2)
To evaluate the steady state pharmacokinetics of (R) and (S) Warfarin when co-administered with PTK787/ZK 222584
Measured: 2 weeks
Safety of low dose warfarin when co-administered with PTK787/ZK 222584
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study startMay 2004
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Joel R. Hecht, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091299
- Sponsor's protocol ID
- CDR0000386239
- Other IDs
- UCLA-0403067-01, NOVARTIS-CPTK7870113
- Status last verified
- Aug 2012
- First submitted
- 7 Sep 2004
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non Randomized , One Sequence, Add-On Study to Investigate the Effects of PTK787/ZK 222584 on the Pharmacokinetics and Pharmacodynamics of Warfarin at Steady-States in Cancer Patients
- ClinicalTrials.gov ID
- NCT00091299
- Acronym / sponsor ID
- CDR0000386239
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- May 2004
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Sep 2004 (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.
RATIONALE: Vatalanib may stop the growth of tumor cells by stopping blood flow to the tumor. Warfarin may be effective in preventing the formation of blood clots in patients who are undergoing treatment for advanced solid tumors.
PURPOSE: This phase I trial is studying how well giving warfarin together with vatalanib works in treating patients with advanced solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the acute and chronic changes in INR in patients with advanced solid tumors treated with low-dose warfarin and vatalanib.
Secondary
- Determine the steady-state pharmacokinetics of this regimen in these patients.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
- Pharmacokinetic (PK) phase: Patients receive oral low-dose warfarin once daily on days 1-14 and oral vatalanib once daily, 1 hour before warfarin administration, on days 2-14 in the absence of disease progression or unacceptable toxicity.
- Continuation phase: Patients not experiencing a drug interaction in the PK phase continue to receive oral vatalanib and oral low-dose warfarin once daily. Patients experiencing a drug interaction (INR > 2.0) in the PK phase receive oral vatalanib alone once daily. Continuation therapy continues indefinitely in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| warfarin | Experimental | Drug: warfarin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically confirmed advanced solid tumor
- Progressed despite standard therapy OR no known standard therapy exists
- -- Currently receiving OR a candidate for prophylactic low-dose warfarin (1 mg/day)
- INR ≤ 1.4
- Must be an extensive metabolizer of CYP2C9 (at least 1 wild type allelle: *1)
Key exclusion criteria (18 listed)
- No poor metabolizers of CYP2C9 (2 alleles of either *2 or *3)
- brain metastases
- history of or active coagulation disorders
- significant risk for bleeding
- uncontrolled high blood pressure (BP), defined as diastolic BP > 90 mm Hg or systolic BP > 140 mm Hg
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 |
|---|---|---|
| warfarin | Drug | warfarin |
Primary outcome
To evaluate acute and chronic changes in INR when Warfarin is co-administered with PTK787/ZK 222584
Time frame: 2 weeks
2 secondary outcomes
To evaluate the steady state pharmacokinetics of (R) and (S) Warfarin when co-administered with PTK787/ZK 222584
Time frame: 2 weeks
Safety of low dose warfarin when co-administered with PTK787/ZK 222584
Time frame: 2 weeks
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 5 Aug 2020.
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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.
Joel R. Hecht, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing warfarin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Jonsson Comprehensive Cancer Center 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 23 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 5 Aug 2020. 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 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.
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?
To evaluate acute and chronic changes in INR when Warfarin is co-administered with PTK787/ZK 222584 (time frame: 2 weeks). 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 5 Aug 2020.