MyelomaPhase 1/2NCT00469209
Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients
A Phase 1/2 study testing Trisenox (Arsenic Trioxide), Velcade (Bortezomib) and Melphalan in people with Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma 2. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Myeloma
- What is being tested?
- Trisenox (Arsenic Trioxide), Velcade (Bortezomib) and Melphalan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2008
- Phase
- Phase 1/2
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a) Primary Refractory Disease (defined as failure to achieve even a partial response to induction therapy) b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) Relapsing after prior therapy (disease relapsing after achieving a partial or complete response to prior conventional or high-dose therapy).
- Age up to 75 years.
- Zubrod performance status of <2.
- Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced expiratory volume (FEV1), forced volume vital capacity (FVC) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >40%. No symptomatic pulmonary disease.
- Serum bilirubin <2 times upper limit of normal, alanine aminotransferase/SGPT <4 times upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites >1L prior to drainage.
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- HIV-negative.
- Negative Beta human chorionic gonadotrophin (hCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
- Patient or guardian able to sign informed consent
- Corrected QT interval less than 470 msec.
Who cannot join
- Corrected QT interval greater than 470 msec.
- Patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
- Patients with non-secretory myeloma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of the Combination of Bortezomib With Arsenic Trioxide, Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma
Primary Objectives:
- To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
- To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
- To determine the effects of bortezomib on melphalan pharmacokinetics
Read the detailed description
Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die. High-dose melphalan is considered the standard of care for multiple myeloma. Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die. Arsenic trioxide may cause cancer cells to die, and researchers want to find out if arsenic trioxide helps melphalan in killing cancer cells. Vitamin C makes arsenic trioxide more available inside the cancer cells, and researchers want to learn if Vitamin C makes arsenic trioxide more effective.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Your complete medical history will be recorded. You will have a dental exam to check for any infected teeth or gums that may flare up after chemotherapy.
You will have a bone marrow aspirate and biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. Cytogenetic tests will be performed on the aspirate sample to look for any genetic abnormalities in your DNA. You will have x-rays of your bones taken. The study doctor will look at the x-rays to see if there are any myeloma-related bone changes. You will also have a chest x-ray.
You will have blood (about 2 tablespoons) and urine collected for routine tests. You will have a pulmonary function test, to check if your lungs are strong enough for high-dose chemotherapy. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will also have a MUGA scan to evaluate the function of your heart. Women who are able to have children must have a negative blood pregnancy test. The blood will be drawn as part of the 2 tablespoons drawn at screening.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of dice) to one of 3 treatment groups. There is an equal chance of being assigned to any of the 3 groups. All 3 groups will receive melphalan, arsenic trioxide, and Vitamin C. The second and third groups will also receive bortezomib, but at different dose levels. The first 3 participants assigned to receive bortezomib on this study will receive the lower of 2 bortezomib dose levels.
You will receive arsenic trioxide through a needle in a vein over 2 hours, once a day for 7 days (Days -9 to -3). At the same time, you will receive Vitamin C once a day through the vein for 7 days. After you receive the arsenic trioxide on Days -4 and -3, you will receive melphalan through the vein over 30 minutes.
If you are in Group 2 or 3, you will receive bortezomib by an intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
You will receive standard inpatient and outpatient stem cell transplant care and testing. You will have to sign a separate consent form that describes the transplant procedure and its risks. Your stem cells will be reinfused 2 days after the last dose of melphalan. To check for any side effects, you will have an ECG performed 14 days after the transplant.
If intolerable side effects from the chemotherapy occur or there is sign of disease after the transplant, you will be taken off study. If you have already received melphalan and side effects occur, then the transplant will happen. However, if intolerable side effects develop before melphalan, then you may be taken off study without having the transplant. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant physician decides it is necessary.
If there is no sign of disease after the transplant, you will have routine follow-up visits. Blood (about 2 tablespoons) will be drawn for routine tests at least once a week during the first month after the transplant, and then once every month for the next 3 months after that. At about 3, 6, and 12 months after the transplant, you will have bone marrow biopsies and aspirates performed to check the status of the disease. You will have blood (about 2 tablespoons) and urine collected for routine tests. At 12 months after the transplant, you will have x-rays of your bones taken.
One (1) year after the transplant, your participation in this study will be over.
This is an investigational study. Bortezomib, arsenic trioxide, and melphalan are commercially available and FDA-approved for use in patients with myeloma. However, their use in combination with Vitamin C (also commercially available) is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trisenox (Arsenic Trioxide)Drug
Also called ATO
0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
Velcade (Bortezomib)Drug
Also called PDP-341, MLN341, PS-341
Arm 1 (Level 1):
1.0 mg/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
Arm 2 (Level 2):
1.5 mg/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
MelphalanDrug
Also called Alkeran
100 mg/m2 by vein days -4,-3, over 30 minutes
Vitamin C (Ascorbic Acid)Drug
1000 mg once a day through the vein for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| No Bortezomib | Active comparator | Arm 1: Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily Receives: Drug: Trisenox (Arsenic Trioxide); Drug: Melphalan; Drug: Vitamin C (Ascorbic Acid) |
| Bortezomib 1.0 mg/m^2 | Active comparator | Arm 2: Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily Receives: Drug: Trisenox (Arsenic Trioxide); Drug: Velcade (Bortezomib); Drug: Melphalan; Drug: Vitamin C (Ascorbic Acid) |
| Bortezomib 1.5 mg/m^2 | Active comparator | Arm 3: Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily Receives: Drug: Trisenox (Arsenic Trioxide); Drug: Velcade (Bortezomib); Drug: Melphalan; Drug: Vitamin C (Ascorbic Acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Reaching Complete Response (CR)
Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with <5% plasma cells, <1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.
Measured: Baseline through Day 180, with assessments at Day 90 and Day 180
Secondary outcomes (1)
Time to Toxicity
The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3.
Measured: Baseline to event occurence (assessed weekly first 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startJun 2006
- Primary completionDec 2008
- Study completionDec 2008
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 MyelomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Muzaffar H. Qazilbash, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469209
- Sponsor's protocol ID
- 2005-0893
- Status last verified
- Sep 2020
- First submitted
- 3 May 2007
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Combination of Bortezomib With Arsenic Trioxide, Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00469209
- Acronym / sponsor ID
- 2005-0893
- Conditions
- Myeloma
- Keywords
- Multiple Myeloma, Melphalan, Trisenox, Arsenic Trioxide, Ascorbic Acid, Vitamin C, Velcade, Bortezomib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Posted 25 Apr 2011
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 toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
- To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
- To determine the effects of bortezomib on melphalan pharmacokinetics
Detailed description
Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die. High-dose melphalan is considered the standard of care for multiple myeloma. Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die. Arsenic trioxide may cause cancer cells to die, and researchers want to find out if arsenic trioxide helps melphalan in killing cancer cells. Vitamin C makes arsenic trioxide more available inside the cancer cells, and researchers want to learn if Vitamin C makes arsenic trioxide more effective.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Your complete medical history will be recorded. You will have a dental exam to check for any infected teeth or gums that may flare up after chemotherapy.
You will have a bone marrow aspirate and biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. Cytogenetic tests will be performed on the aspirate sample to look for any genetic abnormalities in your DNA. You will have x-rays of your bones taken. The study doctor will look at the x-rays to see if there are any myeloma-related bone changes. You will also have a chest x-ray.
You will have blood (about 2 tablespoons) and urine collected for routine tests. You will have a pulmonary function test, to check if your lungs are strong enough for high-dose chemotherapy. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will also have a MUGA scan to evaluate the function of your heart. Women who are able to have children must have a negative blood pregnancy test. The blood will be drawn as part of the 2 tablespoons drawn at screening.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of dice) to one of 3 treatment groups. There is an equal chance of being assigned to any of the 3 groups. All 3 groups will receive melphalan, arsenic trioxide, and Vitamin C. The second and third groups will also receive bortezomib, but at different dose levels. The first 3 participants assigned to receive bortezomib on this study will receive the lower of 2 bortezomib dose levels.
You will receive arsenic trioxide through a needle in a vein over 2 hours, once a day for 7 days (Days -9 to -3). At the same time, you will receive Vitamin C once a day through the vein for 7 days. After you receive the arsenic trioxide on Days -4 and -3, you will receive melphalan through the vein over 30 minutes.
If you are in Group 2 or 3, you will receive bortezomib by an intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
You will receive standard inpatient and outpatient stem cell transplant care and testing. You will have to sign a separate consent form that describes the transplant procedure and its risks. Your stem cells will be reinfused 2 days after the last dose of melphalan. To check for any side effects, you will have an ECG performed 14 days after the transplant.
If intolerable side effects from the chemotherapy occur or there is sign of disease after the transplant, you will be taken off study. If you have already received melphalan and side effects occur, then the transplant will happen. However, if intolerable side effects develop before melphalan, then you may be taken off study without having the transplant. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant physician decides it is necessary.
If there is no sign of disease after the transplant, you will have routine follow-up visits. Blood (about 2 tablespoons) will be drawn for routine tests at least once a week during the first month after the transplant, and then once every month for the next 3 months after that. At about 3, 6, and 12 months after the transplant, you will have bone marrow biopsies and aspirates performed to check the status of the disease. You will have blood (about 2 tablespoons) and urine collected for routine tests. At 12 months after the transplant, you will have x-rays of your bones taken.
One (1) year after the transplant, your participation in this study will be over.
This is an investigational study. Bortezomib, arsenic trioxide, and melphalan are commercially available and FDA-approved for use in patients with myeloma. However, their use in combination with Vitamin C (also commercially available) is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Bortezomib | Active comparator | Drug: Trisenox (Arsenic Trioxide), Drug: Melphalan, Drug: Vitamin C (Ascorbic Acid)Arm 1: Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily |
| Bortezomib 1.0 mg/m^2 | Active comparator | Drug: Trisenox (Arsenic Trioxide), Drug: Velcade (Bortezomib), Drug: Melphalan, Drug: Vitamin C (Ascorbic Acid)Arm 2: Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily |
| Bortezomib 1.5 mg/m^2 | Active comparator | Drug: Trisenox (Arsenic Trioxide), Drug: Velcade (Bortezomib), Drug: Melphalan, Drug: Vitamin C (Ascorbic Acid)Arm 3: Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- a) Primary Refractory Disease (defined as failure to achieve even a partial response to induction therapy) b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) Relapsing after prior therapy (disease relapsing after achieving a partial or complete response to prior conventional or high-dose therapy).
- Age up to 75 years.
- Zubrod performance status of <2.
- Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced expiratory volume (FEV1), forced volume vital capacity (FVC) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >40%. No symptomatic pulmonary disease.
Key exclusion criteria (3 listed)
- Corrected QT interval greater than 470 msec.
- Patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
- Patients with non-secretory myeloma.
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 |
|---|---|---|
| Trisenox (Arsenic Trioxide)Also: ATO0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3). | Drug | Bortezomib 1.0 mg/m^2, Bortezomib 1.5 mg/m^2, No Bortezomib |
| Velcade (Bortezomib)Also: PDP-341, MLN341, PS-341Arm 1 (Level 1): 1.0 mg/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). Arm 2 (Level 2): 1.5 mg/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). | Drug | Bortezomib 1.0 mg/m^2, Bortezomib 1.5 mg/m^2 |
| MelphalanAlso: Alkeran100 mg/m2 by vein days -4,-3, over 30 minutes | Drug | Bortezomib 1.0 mg/m^2, Bortezomib 1.5 mg/m^2, No Bortezomib |
| Vitamin C (Ascorbic Acid)1000 mg once a day through the vein for 7 days. | Drug | Bortezomib 1.0 mg/m^2, Bortezomib 1.5 mg/m^2, No Bortezomib |
Primary outcome
Number of Patients Reaching Complete Response (CR)
Time frame: Baseline through Day 180, with assessments at Day 90 and Day 180
Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with <5% plasma cells, <1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.
1 secondary outcome
Time to Toxicity
Time frame: Baseline to event occurence (assessed weekly first 30 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- 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.
Muzaffar H. Qazilbash, MD principal investigator
M.D. 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 1/2 study testing Trisenox (Arsenic Trioxide), Velcade (Bortezomib) and Melphalan in people with Myeloma, 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 10 inclusion and 3 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 24 Sep 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 combined 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.
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 25 Apr 2011). 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 Reaching Complete Response (CR) (time frame: Baseline through Day 180, with assessments at Day 90 and Day 180). 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 24 Sep 2020.