LymphomaPhase 2NCT00810576
Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma
A Phase 2 study testing Vorinostat and Bortezomib in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib 2. To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Vorinostat and Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must have an established diagnosis of relapsed or refractory T-cell NHL Eligible histologies include; Peripheral T-cell lymphoma (unspecified), CD 30 + anaplastic large cell lymphoma ( ALK-1 positive and ALK-1 negative), angioimmunoblastic T-cell lymphoma, angiocentric/nasal type T/NK-cell lymphoma, intestinal T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma, transformed Mycosis fungoides; All patients must have had at last one prior system regimen (radiation therapy does not qualify as systemic treatment).
- Patients who are eligible for blood and marrow transplant can receive this treatment to maximal reduction of tumor bulk: A minimum of two cycles of therapy will be given before crossing over to transplant.
- Patients must have at least one clear-cut bi-dimensionally measurable site by physical exam and/or computed tomography: Baseline measurements of measurable sites and evaluation of evaluable disease must be obtained within four weeks prior to registration of this study.
- Patient may have had prior radiation therapy for localized disease: Therapy must be completed at last four weeks before the enrollment in the study.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Patients must be age 18 years old and above.
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- Patients are required to have adequate bone marrow reserve as indicated: Absolute neutrophil count (ANC) >/= 1000/mm^3; Platelets >/= 80,000/mm^3; Hemoglobin >/= 8g/dL; If there is bone marrow involvement by lymphoma then there is no minimum level of counts required; These values must be obtained within two weeks before protocol entry.
- Patients must have adequate liver function as indicated by:Bilirubin </= 1.5 times the upper limit of normal (ULN); Alanine transaminase (ALT) </= 2 times the (ULN) or aspartate transaminase (AST) </= 2 times the ULN; These values must be obtained within two weeks before protocol entry.
- Patients are required to have adequate renal function as indicated by a serum creatinine </= 2.5 mg/dL; This value must be obtained within two weeks before protocol entry.
- Male patients must agree to use an accepted and effective method of contraception for the duration of the study.
- Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized).
- Female patients of childbearing potential must have a negative serum pregnancy test (Beta hCG) within 72 hours of receiving the first dose of vorinostat.
- Patients must have the ability able to give informed consent.
Who cannot join
- Patients with: T-cell lymphoma with skin involvement only are excluded if they have no evidence of systemic disease; T-cell prolymphocytic leukemia (T-PLL); T-cell large granular lymphocytic leukemia; Primary cutaneous CD30+ disorders: anaplastic large cell lymphoma and lymphomatoid papulosis
- Patients with active Hepatitis B and/or Hepatitis C infection.
- Patients with known HIV infection are excluded: These patients are excluded secondary to potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy.
- Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
- Patients with left ventricular ejection fraction (LVEF) < 45%.
- Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: Congestive heart failure; Severe CAD; Cardiomyopathy; Uncontrolled cardiac arrhythmia; Unstable angina pectoris; Recent MI.
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- Patients with prior exposure to either vorinostat (including other HDAC inhibitors except valproic acid) or bortezomib: Patients who have received valproic acid (VPA) for the treatment of seizures may be enrolled on this study, but must not have received VPA within 30 days of study enrollment.
- Patients who are pregnant or breast-feeding: Effects of this treatment on the fetus and young children are unknown at this time.
- Patients who have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast who is currently without evidence of disease.
- Patients undergoing anti-neoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within the past four weeks. Receipt of systemic corticosteroids within 7 days of study treatment unless patient has been taking a continuous dose of no more than 10 mg/day of prednisone for at least 1 month.
- Patients with deep vein thrombosis within three months.
- Patients with lymphoma involvement of the CNS.
- Patients who have undergone prior allogenic transplantation: Prior autologous transplantation is accepted.
- Patient with concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and anti-tumor activity of vorinostat and/or bortezomib.
- Patient with a history of allergic reaction attributable to compounds containing boron or mannitol.
- Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
- Patients with grade 2 or more neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study To Determine The Safety and Efficacy Of The Combination of Vorinostat and Bortezomib In Patients With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
Primary Objectives:
- To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib
- To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL.
Secondary Objectives:
- To assess overall survival and time to treatment failure in patients with T-cell NHL treated with the combination of vorinostat and bortezomib.
- Correlative studies will be done to assess the role of vorinostat mediated apoptosis along with bortezomib synergy. Changes in marker expression from baseline to post treatment will be correlated with patient clinical response.
Read the detailed description
The Study Drugs:
Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die.
Bortezomib is designed to block a protein that plays a role in cell function and growth. This may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Days 1-14 of each 21-day study cycle, you will take vorinostat. Vorinostat capsules are taken by mouth, 2 times a day (1 time in the morning and 1 time in the evening). The capsules must be taken with food (within 30 minutes after a meal).
On Days 1, 4, 8, and 11 of all cycles you will receive bortezomib through a needle in your vein. This will take less than 1 minute.
If you begin to experience severe or intolerable side effects, the study drug schedule may be stopped for up to 2 weeks. If the side effects improve, you may be able to begin to receive the study drugs again, with a lower dose of bortezomib. The vorinostat dose will not be changed. If you continue to have severe or intolerable side effects with the lower dose of bortezomib, you will be taken off study.
Study Visits:
On Day 1 of all cycles, the following tests and procedures will be performed:
- You will receive the vorinostat capsules (a 14-day supply for each study cycle) and instructions on how to take the drug. You will be instructed to return any unused vorinostat capsules back to the study staff at the end of each cycle.
- Your medical history will be recorded, including any drugs that you are taking.
- You will be asked about any side effects you may have.
- You will have a physical exam.
- You will have a neurological exam.
On Day 1, 4, 8, and 11 of all cycles, your vital signs will be measured.
On Day 8 of all cycles, blood will be drawn (about 5 teaspoons) for routine tests.
On Day 1 of every other cycle (Cycles 3, 5, 7, and so on), the following tests and procedures will be performed:
- You will have CT scans and/or Positron emission tomography (PET) scans to check the status of the disease.
- Blood (about 5 teaspoons) will be drawn for routine tests and to check the status of the disease.
- If the doctor thinks it is necessary, you may have a bone marrow aspirate and/or biopsy.
You will have computed tomography (CT) scans and/or PET scans, as needed, every 2 cycles (Cycles 2, 4, 6 and so on), to check the status of the disease.
Length of Study:
You will receive the study drugs for up to 6 months (8 cycles). After 6 months (8 cycles) of receiving the study drugs, if the disease has not gotten worse or has become better, you may be able to stay on study and continue receiving the study drugs. The study drugs would continue to be given at the same dose and on the same schedule. The study visits, blood collections, and optional biopsies will also continue on the same schedule.
If the disease gets worse or you develop severe or intolerable side effects at any time, you will be taken off the study drugs.
End-of-Study Visit:
If you go off study treatment for any reason, you will have an end-of-study visit within 4 weeks of your last dose of study drug or before starting a new treatment. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including a measurement of your vital signs.
- You will have a neurological exam.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
- Blood (about 5 teaspoons) will be drawn for routine tests.
- You will have a CT scan and PET scans to check the status of the disease.
Follow-Up Visits:
After you are off study treatment, you will be contacted by phone call every 2 months to check on how you are doing for up to 5 years. These phone calls will last about 5 minutes.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lymphoma
- Being tested
- Vorinostat, Bortezomib
- Keywords
- Relapsed T-Cell Non-Hodgkin's Lymphoma, Refractory T-Cell Non-Hodgkin's Lymphoma, NHL, T-cell NHL, vorinostat, SAHA, Suberoylanilide Hydroxamic Acid, MSK-390, Zolinza, Bortezomib, Velcade, LDP-341, MLN341, PS-341, Peripheral T-cell lymphoma, CD 30 + anaplastic large cell lymphoma, Angioimmunoblastic T-cell lymphoma, Angiocentric/nasal type T/NK-cell lymphoma, Intestinal T-cell lymphoma, Hepatosplenic gamma delta T-cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, T-Cell, Lymphoma, T-Cell, Peripheral, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Enteropathy-Associated T-Cell Lymphoma, Subcutaneous panniculitis-like T-cell lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorinostatDrug
Also called SAHA, Suberoylanilide Hydroxamic Acid, MSK-390, Zolinza
Dose of 200 mg by mouth twice daily on days 1-14 of each 21-day study.
BortezomibDrug
Also called Velcade, LDP-341, MLN341, PS-341
Dose of 1.3 mg/m^2 by vein on days 1, 4, 8, and 11 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Vorinostat + Bortezomib | Experimental | Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenous (IV) on Days 1, 4, 8, 11. Receives: Drug: Vorinostat; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Response
Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.
Measured: Every two 21-day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Barbara Pro, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810576
- Sponsor's protocol ID
- 2007-0658
- Status last verified
- Aug 2012
- First submitted
- 16 Dec 2008
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study To Determine The Safety and Efficacy Of The Combination of Vorinostat and Bortezomib In Patients With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00810576
- Acronym / sponsor ID
- 2007-0658
- Conditions
- Lymphoma
- Keywords
- Relapsed T-Cell Non-Hodgkin's Lymphoma, Refractory T-Cell Non-Hodgkin's Lymphoma, NHL, T-cell NHL, vorinostat, SAHA, Suberoylanilide Hydroxamic Acid, MSK-390
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Posted 9 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib
- To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL.
Secondary Objectives:
- To assess overall survival and time to treatment failure in patients with T-cell NHL treated with the combination of vorinostat and bortezomib.
- Correlative studies will be done to assess the role of vorinostat mediated apoptosis along with bortezomib synergy. Changes in marker expression from baseline to post treatment will be correlated with patient clinical response.
Detailed description
The Study Drugs:
Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die.
Bortezomib is designed to block a protein that plays a role in cell function and growth. This may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Days 1-14 of each 21-day study cycle, you will take vorinostat. Vorinostat capsules are taken by mouth, 2 times a day (1 time in the morning and 1 time in the evening). The capsules must be taken with food (within 30 minutes after a meal).
On Days 1, 4, 8, and 11 of all cycles you will receive bortezomib through a needle in your vein. This will take less than 1 minute.
If you begin to experience severe or intolerable side effects, the study drug schedule may be stopped for up to 2 weeks. If the side effects improve, you may be able to begin to receive the study drugs again, with a lower dose of bortezomib. The vorinostat dose will not be changed. If you continue to have severe or intolerable side effects with the lower dose of bortezomib, you will be taken off study.
Study Visits:
On Day 1 of all cycles, the following tests and procedures will be performed:
- You will receive the vorinostat capsules (a 14-day supply for each study cycle) and instructions on how to take the drug. You will be instructed to return any unused vorinostat capsules back to the study staff at the end of each cycle.
- Your medical history will be recorded, including any drugs that you are taking.
- You will be asked about any side effects you may have.
- You will have a physical exam.
- You will have a neurological exam.
On Day 1, 4, 8, and 11 of all cycles, your vital signs will be measured.
On Day 8 of all cycles, blood will be drawn (about 5 teaspoons) for routine tests.
On Day 1 of every other cycle (Cycles 3, 5, 7, and so on), the following tests and procedures will be performed:
- You will have CT scans and/or Positron emission tomography (PET) scans to check the status of the disease.
- Blood (about 5 teaspoons) will be drawn for routine tests and to check the status of the disease.
- If the doctor thinks it is necessary, you may have a bone marrow aspirate and/or biopsy.
You will have computed tomography (CT) scans and/or PET scans, as needed, every 2 cycles (Cycles 2, 4, 6 and so on), to check the status of the disease.
Length of Study:
You will receive the study drugs for up to 6 months (8 cycles). After 6 months (8 cycles) of receiving the study drugs, if the disease has not gotten worse or has become better, you may be able to stay on study and continue receiving the study drugs. The study drugs would continue to be given at the same dose and on the same schedule. The study visits, blood collections, and optional biopsies will also continue on the same schedule.
If the disease gets worse or you develop severe or intolerable side effects at any time, you will be taken off the study drugs.
End-of-Study Visit:
If you go off study treatment for any reason, you will have an end-of-study visit within 4 weeks of your last dose of study drug or before starting a new treatment. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including a measurement of your vital signs.
- You will have a neurological exam.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
- Blood (about 5 teaspoons) will be drawn for routine tests.
- You will have a CT scan and PET scans to check the status of the disease.
Follow-Up Visits:
After you are off study treatment, you will be contacted by phone call every 2 months to check on how you are doing for up to 5 years. These phone calls will last about 5 minutes.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vorinostat + Bortezomib | Experimental | Drug: Vorinostat, Drug: BortezomibVorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenous (IV) on Days 1, 4, 8, 11. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have an established diagnosis of relapsed or refractory T-cell NHL Eligible histologies include; Peripheral T-cell lymphoma (unspecified), CD 30 + anaplastic large cell lymphoma ( ALK-1 positive and ALK-1 negative), angioimmunoblastic T-cell lymphoma, angiocentric/nasal type T/NK-cell lymphoma, intestinal T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma, transformed Mycosis fungoides; All patients must have had at last one prior system regimen (radiation therapy does not qualify as systemic treatment).
- Patients who are eligible for blood and marrow transplant can receive this treatment to maximal reduction of tumor bulk: A minimum of two cycles of therapy will be given before crossing over to transplant.
- Patients must have at least one clear-cut bi-dimensionally measurable site by physical exam and/or computed tomography: Baseline measurements of measurable sites and evaluation of evaluable disease must be obtained within four weeks prior to registration of this study.
- Patient may have had prior radiation therapy for localized disease: Therapy must be completed at last four weeks before the enrollment in the study.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Key exclusion criteria (17 listed)
- Patients with: T-cell lymphoma with skin involvement only are excluded if they have no evidence of systemic disease; T-cell prolymphocytic leukemia (T-PLL); T-cell large granular lymphocytic leukemia; Primary cutaneous CD30+ disorders: anaplastic large cell lymphoma and lymphomatoid papulosis
- Patients with active Hepatitis B and/or Hepatitis C infection.
- Patients with known HIV infection are excluded: These patients are excluded secondary to potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy.
- Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
- Patients with left ventricular ejection fraction (LVEF) < 45%.
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 |
|---|---|---|
| VorinostatAlso: SAHA, Suberoylanilide Hydroxamic Acid, MSK-390, ZolinzaDose of 200 mg by mouth twice daily on days 1-14 of each 21-day study. | Drug | Vorinostat + Bortezomib |
| BortezomibAlso: Velcade, LDP-341, MLN341, PS-341Dose of 1.3 mg/m^2 by vein on days 1, 4, 8, and 11 of a 21 day cycle. | Drug | Vorinostat + Bortezomib |
Primary outcome
Number of Patients With Response
Time frame: Every two 21-day cycles
Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Barbara Pro, MD principal investigator
UT MD Anderson 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 2 study testing Vorinostat and Bortezomib in people with Lymphoma, run by M.D. Anderson 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 13 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 Aug 2012. 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?
Yes. Results are posted in the registry (first posted 9 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Response (time frame: Every two 21-day cycles). 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 7 Aug 2012.