Advanced CancersPhase 1NCT00939172
TTP607 in Refractory Solid Malignancies
A Phase 1 study testing TTP607 in people with Advanced Cancers and Lymphoma, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of TTP607 that can be given to patients with a solid tumor or lymphoma. The safety of TTP607 will also be studied. Researchers will also do pharmacokinetic (PK) testing of TTP607. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers, Lymphoma
- What is being tested?
- TTP607
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to not given
- 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
- Patients with pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which there is no standard therapy.
- Measurable disease at baseline.
- At least four weeks since the last dose of prior chemotherapy, radiation therapy, or investigational agents, six weeks if the last regimen included BCNU or mitomycin C, six weeks if the agent was an antibody, four weeks if a chimeric antibody. For targeted therapies such as Gleevec®, Tarceva®, Nexavar®, Iressa®, or Sutent® at least five half-lives need to have elapsed since the last dose. Patients must be recovered from the adverse effects of prior therapy at the time of enrollment.
- Age >/=18 years, male or female patients.
- Women of child-bearing potential or men whose sexual partners are women of child-bearing potential must agree to use two methods of adequate contraception (i.e., hormonal and barrier method of birth control) prior to study entry, for the duration of the study, and for 30 days after the last dose of study medication.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
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- Patients must have normal organ and marrow function as defined: leukocytes >/= 3,000/mcL; absolute neutrophil count >/=1,500/mcL; platelets >/= 100,000/mcL; total bilirubin </= 2.0 mg/dL; AST(SGOT)/ALT(SGPT) </= 2.5 x upper limit of normal; and creatinine </= 2.0 mg/dL
- Patients must have an existing patent and viable central venous catheter, or have such a line inserted within 28 days prior to initiation of study drug.
- Patients must be able to understand and willing to sign a written informed consent document and have the capacity to follow study instructions.
Who cannot join
- Uncontrolled concurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, life-threatening cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results. Patients with a history of myocardial infarction in the last three months are also excluded from the trial.
- Patients with known brain metastases that are symptomatic
- Patients with leukemias or myelodysplastic syndrome (MDS).
- Patients who have undergone bone marrow or stem cell transplantation within the last 5 years.
- A requirement, as judged by the Principal Investigator, for primary prophylaxis with colony stimulating factors based on an expectation by the investigator of a risk of febrile neutropenia of 20% or greater or clinical factors that predispose the patient to increased complications from prolonged neutropenia as discussed in the latest American Society of Clinical Oncology (ASCO) recommendations for the use of white blood cell growth factor guidelines.
- Nursing or pregnant women.
- Documented HIV, HBV or HCV infection.
- Patients with hypersensitivity to compounds of similar chemical or biologic composition to TTP607 or constituents of the intravenous (i.v.) formulation.
About this study
Official title: An Open Label, Phase I, Single Group Assignment Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TTP607 Administered in Cycles of Five Daily One to Four Hour Infusions to Patients With Advanced Refractory Solid Malignancies
The goal of this clinical research study is to find the highest tolerable dose of TTP607 that can be given to patients with a solid tumor or lymphoma. The safety of TTP607 will also be studied.
Researchers will also do pharmacokinetic (PK) testing of TTP607. PK testing measures the amount of a drug in the body at different time points.
Read the detailed description
The Study Drug:
TTP607 is designed to work by blocking the action of certain enzymes (proteins) in the blood that are responsible for abnormal growth of cancer cells. This may cause the cancer cells to eventually die.
Dose Level Assignment:
If you are found to be eligible to take part in this study, you will be enrolled in a group of 3-6 participants. The dose you receive will be based on when you join this study (on how many participants have been enrolled before you, and on the safety data that is available at that time). The first group of participants will receive the lowest dose of TTP607. Each new group of participants will receive the next highest dose of the study drug, as long as no intolerable side effects occur. This process will continue until the highest tolerable dose of TTP607 is reached. Once the highest tolerable dose is found, 12 additional participants will be enrolled and treated at that dose, so that researchers can learn more about the effects of the study drug on the tumor. Both you and your study doctor will know what dose of the study drug you are receiving.
Study Drug Administration:
Starting on Day 1 of Cycle 1, you will receive TTP607 by central venous catheter (CVC or central venous line). There are several types of central venous catheters. Each type of catheter is a flexible, long, thin tube that is inserted through a vein, under a local anesthetic, through a small cut in your chest (near your heart). Some chemotherapy drugs are not suitable to be given into the veins in your hand or arm, so these drugs must be given into a larger vein. The CVC may also be used for drawing blood samples that are needed regularly. Using the CVC for these blood draws will lower the need for repeated blood draws from your arm. TTP607 will be given over 1-4 hours depending on the dose you receive, each day for 5 days in a row, followed by a 10-day "rest period" (no study drug). This 15 days is considered 1 cycle.
Study Visits:
On Day 1 (All Cycles):
You will have the below tests/procedures during your study visits:
- Your vital signs will be taken.
- You will have blood (about 1-2 tablespoons each time) drawn and urine collected for routine tests.
- You will be asked about any other medications that you may be taking and any side effects you may have experienced since your last visit.
- You will have an ECG.
- You will have a brief physical exam and routine eye exam.
- You will have a computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) scan to check the size of the tumor.
- You will complete a questionnaire (1 question only) to rate your quality of life over the past week. It should take about 1 minute to complete.
- Women who are able to have children will have a urine pregnancy test.
On Days 2-5 (All Cycles):
The following tests/procedures will be performed before the start of the study drug infusion:
- You will be asked about any side effects that you may have had since your last visit.
- Your weight will be measured.
After the infusion, your vital signs will be measured.
On Days 2-5 (Cycle 1):
You will have an ECG performed, and blood (about 2-3 teaspoons each time) and urine will be collected for routine tests.
On Days 8, 10, and 12 (Cycle 1):
You will have the below tests/procedures during your study visits:
- You will complete the questionnaire to rate your quality of life over the past week.
- You will be asked about any medications you may have taken since your last visit and if you have had any side effects from them.
- You will have an ECG (Day 8 only).
- You will have blood (about 2-3 teaspoons each time) and urine collected for routine tests.
- You will have a brief physical exam and routine eye exam.
- Your weight will be measured (Days 8 and 12).
- Your vital signs will be measured.
On Days 3 and 5 (Cycles 2 and 3):
You will have an ECG.
On Days 2, 3, and 5 (Cycles 2 and 3):
You will have blood (about 2-3 teaspoons each time) drawn and urine collected for routine tests.
On Days 8-12 (Cycles 2, 3, and Further Cycles):
At least once at some time between Days 8 and 12, you will return to the clinic for the following tests/procedures:
- You will complete the questionnaire to rate your quality of life over the past week (on Day 12 of even-numbered cycles).
- You will be asked about any medications you may have taken since your last visit and if you have had any side effects from them.
- You will have an ECG (Cycles 2 and 3).
- You will have blood (about 2-3 teaspoons each time) and urine collected for routine tests.
- You will have a brief physical exam and routine eye exam.
- Your weight and vital signs will be measured.
On Day 5 (Cycle 4 and Further Cycles):
You will have blood (about 2-3 teaspoons each time) and urine collected for routine tests.
PK Testing:
You will have blood (about 2-3 teaspoons each time) and urine samples collected at different times for PK testing of TTP607.
Cycle 1:
Days 1 and 5:
Blood will be drawn immediately before the infusion, at 30 minutes during the infusion, at 60 minutes immediately after the infusion, and at 15 minutes, 30 minutes, 45 minutes, and at 1, 2, 3, 4, and 6 hours after the infusion.
On Day 1, urine will be collected immediately before the infusion and within 3 hours, between 3 and 7 hours, between 7 and 12 hours, and between 12 and 24 hours after the infusion. On Day 5, urine will be collected before the infusion and within 3 hours and between 3 and 7 hours after the infusion.
Days 2, 3, and 4:
Blood will be drawn immediately before the infusion and at 1 hour after the end of the infusion. Urine will be collected immediately before the infusion and within 2 hours after the end of the infusion.
Day 8:
Blood will be drawn at any convenient time, and urine will be collected when you first arrive in the clinic.
Cycles 2 and 3:
Days 1 and 5:
Blood will be drawn before the infusion and at 1 and 2 hours after the infusion, and urine will be collected before the infusion and within 2 hours after infusion.
Days 8-12:
Blood will be drawn at any convenient time, and urine will be collected when you first arrive in the clinic.
Cycle 4 and Further Cycles:
Day 5:
Blood will be drawn 1 hour after the infusion, and urine will be collected immediately before the infusion and within 2 hours after the infusion.
Length of Study:
You will continue on this study, as long as the study doctor thinks it is safe to continue, the cancer does not get worse, and if no intolerable side effects occur. If you continue on to further cycles, you will be on the same study drug schedule and will have the same tests/procedures for study visits, though they may be performed less often.
End-of-Study Visit:
Once you are off this study for any reason, you will have an end-of-study visit about 30 days after your last dose of the study drug. During this visit, you will have the following tests/procedures:
- You will have a complete physical exam, including measurement of your vital signs.
- Your blood (about 2 teaspoons) will be drawn and urine collected for routine tests.
- You will have an ECG.
- You will complete the questionnaire to rate your quality of life over the past week.
- Women who are able to have children will have a blood (about 1 teaspoon) pregnancy test.
This is an investigational study. TTP607 is not FDA approved or commercially available. At this time, it is being used for research purposes only. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancers, Lymphoma
- Being tested
- TTP607
- Keywords
- Advanced Refractory Solid Malignancies, Solid tumor, Lymphoma, TTP607
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTP607Drug
3.3 mg/m^2 given by central venous catheter over 1-4 hours, each day for 5 days in a row, for a 15 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| TTP607 | Experimental | Not described Receives: Drug: TTP607 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: End of each 15 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- vTv Therapeutics
- Responsible party
- Sponsor
- Investigators
- Jennifer J. Wheler, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939172
- Sponsor's protocol ID
- 2007-0219
- Status last verified
- Jul 2012
- First submitted
- 10 Jul 2009
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase I, Single Group Assignment Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TTP607 Administered in Cycles of Five Daily One to Four Hour Infusions to Patients With Advanced Refractory Solid Malignancies
- ClinicalTrials.gov ID
- NCT00939172
- Acronym / sponsor ID
- 2007-0219
- Conditions
- Advanced Cancers, Lymphoma
- Keywords
- Advanced Refractory Solid Malignancies, Solid tumor, Lymphoma, TTP607
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- vTv Therapeutics
- Study start
- Mar 2010
- First posted
- 14 Jul 2009 (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 goal of this clinical research study is to find the highest tolerable dose of TTP607 that can be given to patients with a solid tumor or lymphoma. The safety of TTP607 will also be studied.
Researchers will also do pharmacokinetic (PK) testing of TTP607. PK testing measures the amount of a drug in the body at different time points.
Detailed description
The Study Drug:
TTP607 is designed to work by blocking the action of certain enzymes (proteins) in the blood that are responsible for abnormal growth of cancer cells. This may cause the cancer cells to eventually die.
Dose Level Assignment:
If you are found to be eligible to take part in this study, you will be enrolled in a group of 3-6 participants. The dose you receive will be based on when you join this study (on how many participants have been enrolled before you, and on the safety data that is available at that time). The first group of participants will receive the lowest dose of TTP607. Each new group of participants will receive the next highest dose of the study drug, as long as no intolerable side effects occur. This process will continue until the highest tolerable dose of TTP607 is reached. Once the highest tolerable dose is found, 12 additional participants will be enrolled and treated at that dose, so that researchers can learn more about the effects of the study drug on the tumor. Both you and your study doctor will know what dose of the study drug you are receiving.
Study Drug Administration:
Starting on Day 1 of Cycle 1, you will receive TTP607 by central venous catheter (CVC or central venous line). There are several types of central venous catheters. Each type of catheter is a flexible, long, thin tube that is inserted through a vein, under a local anesthetic, through a small cut in your chest (near your heart). Some chemotherapy drugs are not suitable to be given into the veins in your hand or arm, so these drugs must be given into a larger vein. The CVC may also be used for drawing blood samples that are needed regularly. Using the CVC for these blood draws will lower the need for repeated blood draws from your arm. TTP607 will be given over 1-4 hours depending on the dose you receive, each day for 5 days in a row, followed by a 10-day "rest period" (no study drug). This 15 days is considered 1 cycle.
Study Visits:
On Day 1 (All Cycles):
You will have the below tests/procedures during your study visits:
- Your vital signs will be taken.
- You will have blood (about 1-2 tablespoons each time) drawn and urine collected for routine tests.
- You will be asked about any other medications that you may be taking and any side effects you may have experienced since your last visit.
- You will have an ECG.
- You will have a brief physical exam and routine eye exam.
- You will have a computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) scan to check the size of the tumor.
- You will complete a questionnaire (1 question only) to rate your quality of life over the past week. It should take about 1 minute to complete.
- Women who are able to have children will have a urine pregnancy test.
On Days 2-5 (All Cycles):
The following tests/procedures will be performed before the start of the study drug infusion:
- You will be asked about any side effects that you may have had since your last visit.
- Your weight will be measured.
After the infusion, your vital signs will be measured.
On Days 2-5 (Cycle 1):
You will have an ECG performed, and blood (about 2-3 teaspoons each time) and urine will be collected for routine tests.
On Days 8, 10, and 12 (Cycle 1):
You will have the below tests/procedures during your study visits:
- You will complete the questionnaire to rate your quality of life over the past week.
- You will be asked about any medications you may have taken since your last visit and if you have had any side effects from them.
- You will have an ECG (Day 8 only).
- You will have blood (about 2-3 teaspoons each time) and urine collected for routine tests.
- You will have a brief physical exam and routine eye exam.
- Your weight will be measured (Days 8 and 12).
- Your vital signs will be measured.
On Days 3 and 5 (Cycles 2 and 3):
You will have an ECG.
On Days 2, 3, and 5 (Cycles 2 and 3):
You will have blood (about 2-3 teaspoons each time) drawn and urine collected for routine tests.
On Days 8-12 (Cycles 2, 3, and Further Cycles):
At least once at some time between Days 8 and 12, you will return to the clinic for the following tests/procedures:
- You will complete the questionnaire to rate your quality of life over the past week (on Day 12 of even-numbered cycles).
- You will be asked about any medications you may have taken since your last visit and if you have had any side effects from them.
- You will have an ECG (Cycles 2 and 3).
- You will have blood (about 2-3 teaspoons each time) and urine collected for routine tests.
- You will have a brief physical exam and routine eye exam.
- Your weight and vital signs will be measured.
On Day 5 (Cycle 4 and Further Cycles):
You will have blood (about 2-3 teaspoons each time) and urine collected for routine tests.
PK Testing:
You will have blood (about 2-3 teaspoons each time) and urine samples collected at different times for PK testing of TTP607.
Cycle 1:
Days 1 and 5:
Blood will be drawn immediately before the infusion, at 30 minutes during the infusion, at 60 minutes immediately after the infusion, and at 15 minutes, 30 minutes, 45 minutes, and at 1, 2, 3, 4, and 6 hours after the infusion.
On Day 1, urine will be collected immediately before the infusion and within 3 hours, between 3 and 7 hours, between 7 and 12 hours, and between 12 and 24 hours after the infusion. On Day 5, urine will be collected before the infusion and within 3 hours and between 3 and 7 hours after the infusion.
Days 2, 3, and 4:
Blood will be drawn immediately before the infusion and at 1 hour after the end of the infusion. Urine will be collected immediately before the infusion and within 2 hours after the end of the infusion.
Day 8:
Blood will be drawn at any convenient time, and urine will be collected when you first arrive in the clinic.
Cycles 2 and 3:
Days 1 and 5:
Blood will be drawn before the infusion and at 1 and 2 hours after the infusion, and urine will be collected before the infusion and within 2 hours after infusion.
Days 8-12:
Blood will be drawn at any convenient time, and urine will be collected when you first arrive in the clinic.
Cycle 4 and Further Cycles:
Day 5:
Blood will be drawn 1 hour after the infusion, and urine will be collected immediately before the infusion and within 2 hours after the infusion.
Length of Study:
You will continue on this study, as long as the study doctor thinks it is safe to continue, the cancer does not get worse, and if no intolerable side effects occur. If you continue on to further cycles, you will be on the same study drug schedule and will have the same tests/procedures for study visits, though they may be performed less often.
End-of-Study Visit:
Once you are off this study for any reason, you will have an end-of-study visit about 30 days after your last dose of the study drug. During this visit, you will have the following tests/procedures:
- You will have a complete physical exam, including measurement of your vital signs.
- Your blood (about 2 teaspoons) will be drawn and urine collected for routine tests.
- You will have an ECG.
- You will complete the questionnaire to rate your quality of life over the past week.
- Women who are able to have children will have a blood (about 1 teaspoon) pregnancy test.
This is an investigational study. TTP607 is not FDA approved or commercially available. At this time, it is being used for research purposes only. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTP607 | Experimental | Drug: TTP607 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which there is no standard therapy.
- Measurable disease at baseline.
- At least four weeks since the last dose of prior chemotherapy, radiation therapy, or investigational agents, six weeks if the last regimen included BCNU or mitomycin C, six weeks if the agent was an antibody, four weeks if a chimeric antibody. For targeted therapies such as Gleevec®, Tarceva®, Nexavar®, Iressa®, or Sutent® at least five half-lives need to have elapsed since the last dose. Patients must be recovered from the adverse effects of prior therapy at the time of enrollment.
- Age >/=18 years, male or female patients.
- Women of child-bearing potential or men whose sexual partners are women of child-bearing potential must agree to use two methods of adequate contraception (i.e., hormonal and barrier method of birth control) prior to study entry, for the duration of the study, and for 30 days after the last dose of study medication.
Key exclusion criteria (8 listed)
- Uncontrolled concurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, life-threatening cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results. Patients with a history of myocardial infarction in the last three months are also excluded from the trial.
- Patients with known brain metastases that are symptomatic
- Patients with leukemias or myelodysplastic syndrome (MDS).
- Patients who have undergone bone marrow or stem cell transplantation within the last 5 years.
- A requirement, as judged by the Principal Investigator, for primary prophylaxis with colony stimulating factors based on an expectation by the investigator of a risk of febrile neutropenia of 20% or greater or clinical factors that predispose the patient to increased complications from prolonged neutropenia as discussed in the latest American Society of Clinical Oncology (ASCO) recommendations for the use of white blood cell growth factor guidelines.
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 |
|---|---|---|
| TTP6073.3 mg/m^2 given by central venous catheter over 1-4 hours, each day for 5 days in a row, for a 15 day cycle. | Drug | TTP607 |
Primary outcome
Maximum Tolerated Dose
Time frame: End of each 15 day cycle
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- 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.
Jennifer J. Wheler, MD study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TTP607 in people with Advanced Cancers and Lymphoma, run by M.D. Anderson 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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 31 Jul 2012. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Maximum Tolerated Dose (time frame: End of each 15 day cycle). 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 31 Jul 2012.