Prostate CancerPhase 2NCT00134355
Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer
A Phase 2 study testing PTK787 in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center.
Trial summary
The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PTK787
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Mar 2007
- Phase
- Phase 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic diagnosis of prostate cancer
- No evidence of metastatic disease
- PSA-only progression despite androgen depravation therapy and antiandrogen withdrawal
- Patients must maintain castrate levels of testosterone (<50ng/mL) or continue on LHRH ( Luteinizing Hormone-releasing Hormone) analog therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (A measure of quality of life where 0 represents asymptomatic and 5 represents death)
- No prior anti-VEGF therapy is allowed
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- No investigational or commercial agents or therapies other than LHRH agonists/antagonists may be administered concurrently with intent to treat the patient's malignancy
- Age greater than or equal to 18 years
- Life expectancy greater than 6 months
- Normal organ and marrow function obtained within 14 days prior to registration
- Must use adequate contraception prior to study entry and for the duration of study participation.
Who cannot join
- Patients may continue on a daily multivitamin, but all other herbal or alternative food supplements must be discontinued before registration.
- Patients must be on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy.
- Uncontrolled incurrent illness
- Patients with a "currently active" second malignancy are not eligible.
- Major surgery less than or equal to 4 weeks prior to randomization
- Prior chemotherapy less than or equal to 3 weeks prior to registration
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- Prior biologic or immunotherapy less than or equal to 2 weeks prior to registration
- Prior investigational drugs of any kind less than or equal to 4 weeks prior to registration
- Patients who have had full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy equal or less than 2 weeks prior to registration.
- Patients must not be on nonsteroidal antiandrogen blockade.
- Patients must have no evidence of disease on bone scan or computed tomography (CT) scan of the abdomen/pelvis.
About this study
Official title: Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer
The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate serum vascular endothelial growth factor (VEGF) levels.
Read the detailed description
This is an open-label, phase II trial of PTK787/ZK 222584. Patients will receive 750 mg daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter.
Response Assessment: In the absence of toxicity or clinical progression, patients will remain in the study until their PSA (Prostate-specific Antigen) has doubled from pretreatment baseline.
- Conditions
- Prostate Cancer
- Being tested
- PTK787
- Keywords
- antiangiogenesis therapy, vatalanib
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTK787Drug
| Study group | Role | What they receive |
|---|---|---|
| PTK787 | Experimental | PTK787:
250 mg orally twice daily x 2 wks, then 250 mg orally am, 500 mg orally pm x 1 wk, then 500 mg orally twice daily Receives: Drug: PTK787 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Progression (TTP) in Weeks
Measured: 12 Months
Secondary outcomes (2)
Number of Toxicities in Patients Treated with PTK787
Measured: 30 Days After Last Dose
Overall Survival
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionNov 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Kathleen W. Beekman, MD, Principal investigator, The University of Michigan Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134355
- Sponsor's protocol ID
- UMCC 2005.014
- Status last verified
- Jan 2015
- First submitted
- 23 Aug 2005
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00134355
- Acronym / sponsor ID
- UMCC 2005.014
- Conditions
- Prostate Cancer
- Keywords
- antiangiogenesis therapy, vatalanib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jul 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 24 Aug 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 purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate serum vascular endothelial growth factor (VEGF) levels.
Detailed description
This is an open-label, phase II trial of PTK787/ZK 222584. Patients will receive 750 mg daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter.
Response Assessment: In the absence of toxicity or clinical progression, patients will remain in the study until their PSA (Prostate-specific Antigen) has doubled from pretreatment baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTK787 | Experimental | Drug: PTK787PTK787: 250 mg orally twice daily x 2 wks, then 250 mg orally am, 500 mg orally pm x 1 wk, then 500 mg orally twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologic or cytologic diagnosis of prostate cancer
- No evidence of metastatic disease
- PSA-only progression despite androgen depravation therapy and antiandrogen withdrawal
- Patients must maintain castrate levels of testosterone (<50ng/mL) or continue on LHRH ( Luteinizing Hormone-releasing Hormone) analog therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (A measure of quality of life where 0 represents asymptomatic and 5 represents death)
Key exclusion criteria (11 listed)
- Patients may continue on a daily multivitamin, but all other herbal or alternative food supplements must be discontinued before registration.
- Patients must be on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy.
- Uncontrolled incurrent illness
- Patients with a "currently active" second malignancy are not eligible.
- Major surgery less than or equal to 4 weeks prior to randomization
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 | Drug | PTK787 |
Primary outcome
Time To Progression (TTP) in Weeks
Time frame: 12 Months
2 secondary outcomes
Number of Toxicities in Patients Treated with PTK787
Time frame: 30 Days After Last Dose
Overall Survival
Time frame: 12 Months
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 Jan 2015.
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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.
Kathleen W. Beekman, MD principal investigator
The University of Michigan Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTK787 in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center.
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 11 inclusion and 11 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 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Time To Progression (TTP) in Weeks (time frame: 12 Months). 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 Jan 2015.