Multiple MyelomaPhase 2NCT00165347
Protein Tyrosine Kinases (PTK) in Multiple Myeloma
A Phase 2 study testing PTK787/ZK222584 in people with Multiple Myeloma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- PTK787/ZK222584
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Oct 2006
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years of age.
- Confirmed diagnosis of active progressive multiple myeloma
- History of > 2 prior cytotoxic treatment regimens. Bone marrow transplantation will be considered as one regimen.
- Current measurable disease based on serum and/or urine M protein and/or measurable plasmacytoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Absolute neutrophil count (ANC) > 1,500 mm3
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- Platelets > 100,000 mm3
- Serum creatinine < 1.5 upper limit of normal (ULN)
- Serum bilirubin < 1.5 ULN
- AST/AGOT and ALT/SGPT < 3.0 ULN
- Life expectancy > 12 weeks
Who cannot join
- Chemotherapy < 3 weeks prior to registration.
- Biologic or immunotherapy < 2 weeks prior to registration
- Full field radiotherapy < 4 weeks or limited field radiotherapy < 2 weeks prior to registration.
- History or presence of central nervous system (CNS) disease
- History of leukemia
- History of another primary malignancy with the exception of inactive basal or squamous cell carcinoma of the skin
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- Major surgery < 4 weeks prior to registration
- Prior therapy with anti-vascular endothelial growth factor (VEGF) agents excluding thalidomide, Revimid, velcade and arsenic trioxide
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Pleural effusion or ascites that cause respiratory compromise
- Female patients that are pregnant or breast feeding
- Uncontrolled high blood pressure, history of labile hypertension or history of poor compliance with an antihypertensive regimen
- Unstable angina pectoris
- Symptomatic congestive heart failure
- Myocardial infarction < 6 months prior to registration
- Serious uncontrolled cardiac arrhythmia
- Uncontrolled diabetes
- Active or uncontrolled infection
- Acute or chronic liver disease
- Impairment of gastrointestinal (GI) function or GI disease
- Confirmed HIV infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of PTK787/ZK222584 in Multiple Myeloma
The purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells.
Read the detailed description
Patients will take PTK orally once a day for the duration of their time on the study. Each cycle of chemotherapy will last for 4 weeks.
Measurement of vital signs will be done weekly during the first month of treatment.
Physical exam, vital signs, blood work, a quality of life assessment, and x-ray or MRI wil be performed every 4 weeks.
Patients will remain on the study until their disease fails to respond to treatment or there are intolerable side effects. Typically treatment is performed for 12 weeks and up to one year in patients that are stable and responding.
- Conditions
- Multiple Myeloma
- Being tested
- PTK787/ZK222584
- Keywords
- Multiple myeloma, PTK, Relapsed multiple myeloma, Refractory Multiple myeloma, Myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTK787/ZK222584Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma
Secondary outcomes (2)
To evaluate the progression free survival of patients treated with PTK
to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Novartis
- Investigators
- Nikhil Munshi, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165347
- Sponsor's protocol ID
- 03-257
- Status last verified
- Dec 2007
- First submitted
- 9 Sep 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of PTK787/ZK222584 in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00165347
- Acronym / sponsor ID
- 03-257
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, PTK, Relapsed multiple myeloma, Refractory Multiple myeloma, Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Novartis
- Study start
- Dec 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 14 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 purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells.
Detailed description
Patients will take PTK orally once a day for the duration of their time on the study. Each cycle of chemotherapy will last for 4 weeks.
Measurement of vital signs will be done weekly during the first month of treatment.
Physical exam, vital signs, blood work, a quality of life assessment, and x-ray or MRI wil be performed every 4 weeks.
Patients will remain on the study until their disease fails to respond to treatment or there are intolerable side effects. Typically treatment is performed for 12 weeks and up to one year in patients that are stable and responding.
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 (11 listed)
- Older than 18 years of age.
- Confirmed diagnosis of active progressive multiple myeloma
- History of > 2 prior cytotoxic treatment regimens. Bone marrow transplantation will be considered as one regimen.
- Current measurable disease based on serum and/or urine M protein and/or measurable plasmacytoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (21 listed)
- Chemotherapy < 3 weeks prior to registration.
- Biologic or immunotherapy < 2 weeks prior to registration
- Full field radiotherapy < 4 weeks or limited field radiotherapy < 2 weeks prior to registration.
- History or presence of central nervous system (CNS) disease
- History of leukemia
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/ZK222584 | Drug | – |
Primary outcome
To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma
2 secondary outcomes
To evaluate the progression free survival of patients treated with PTK
to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma
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 21 Dec 2007.
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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.
Nikhil Munshi, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTK787/ZK222584 in people with Multiple Myeloma, run by Dana-Farber Cancer Institute 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 11 inclusion and 21 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 21 Dec 2007. 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 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?
To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma. 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 21 Dec 2007.