ThrombocytopeniaPhase 2NCT00303472
Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)
A Phase 2 study testing Romiplostim in people with Thrombocytopenia and MDS, run by Amgen.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia, MDS, Myelodysplastic Syndromes
- What is being tested?
- Romiplostim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to May 2008
- 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
- Diagnosis of MDS using the World Health Organization classification
- Low or Intermediate-1 risk MDS using the International Prognostic Scoring System (IPSS)
- The mean of two platelet counts taken during the screening period must be ≤ 50 x 10^9/L, with no individual count > 55 x 10^9/L (The mean platelet counts of 5 subjects enrolled at the maximum tolerated dose (MTD) must be ≤ 20 x 10^9/L). Standard of care platelet assessments taken prior to Informed Consent may be used as 1 of the 2 counts taken within 3 weeks prior to study day 1.
- Must be ≥ 18 years of age at the time of obtaining informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the time of screening
- Adequate Liver Function, as evidenced by a serum bilirubin ≤ 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilbert's Disease), alanine aminotransferase (ALT) ≤ 3 times the laboratory normal range, and aspartate aminotransferase (AST) ≤ 3 times the laboratory normal range
- A serum creatinine concentration ≤ 2 mg/dL (≤ 176.6 µmol/L)
- Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 12.1)
Who cannot join
- Currently receiving any treatment for MDS other than transfusions and erythropoietic growth factors. If granulocyte growth factors are currently being received, they cannot be used on or after study day 1
- Clinically significant bleeding within 2 weeks prior to screening (eg, gastrointestinal (GI) bleeds, intracranial hemorrhage)
- Prior malignancy (other than controlled prostate cancer, in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years before screening
- Prior history of bone marrow transplantation
- Persistent peripheral blood monocytosis (≥ 3 months with an absolute monocyte count > 1,000/µL)
- Unstable angina, congestive heart failure (New York Heart Association [NYHA] > class II), uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
Show all 22Show fewer
- Received Anti-Thymocyte Globuline (ATG) within 6 months of screening
- Received hypomethylating agents, immunomodulating agents, histone deacetylase inhibitors, cyclosporine or mycophenolate within 6 weeks of screening
- Received interleukin (IL)-11 (oprelvekin) within 4 weeks before screening
- Concurrent use of granulocyte growth factors (i.e. granulocyte-colony stimulating factor [G-CSF; Neupogen, Granocyte], pegfilgrastim [Neulasta], granulocyte macrophage-colony stimulating factor [GM-CSF; Leukine, Prokine, Sargramostim])
- Have ever previously received recombinant thrombopoietin (rTPO), pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), eltrombopag, or romiplostim
- Less than 4 weeks since receipt of any therapeutic drug or device that is not Food and Drug Administration (FDA) approved for any indication
- Other investigational procedures are excluded
- History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year
- History of venous thrombosis that currently requires anti-coagulation therapy
- Untreated B12 or folate deficiency
- Subject is evidently pregnant (eg, positive human chorionic gonadotropin [HCG] test) or is breast feeding
- Subject is not using adequate contraceptive precautions
- Subject has known hypersensitivity to any recombinant E coli-derived product
- Subject previously has enrolled in this study
- Subject will not be available for follow-up assessment
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
About this study
Official title: An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.
- Being tested
- Romiplostim
- Keywords
- MDS, Myelodysplastic Syndromes, Refractory Cytopenias, Thrombocytopenia
- Medical subject headings
- Thrombocytopenia, Myelodysplastic Syndromes, Cytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomiplostimDrug
Also called AMG 531, Nplate®
| Study group | Role | What they receive |
|---|---|---|
| Part A: 300 µg romiplostim | Experimental | Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. Receives: Drug: Romiplostim |
| Part A: 700 µg romiplostim | Experimental | Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. Receives: Drug: Romiplostim |
| Part A: 1000 µg romiplostim | Experimental | Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. Receives: Drug: Romiplostim |
| Part A: 1500 µg romiplostim | Experimental | Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. Receives: Drug: Romiplostim |
| Part B: 750 µg romiplostim SC QW | Experimental | Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who complete Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. Receives: Drug: Romiplostim |
| Part B: 750 µg romiplostim SC Q2W | Experimental | Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who complete Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase. Receives: Drug: Romiplostim |
| Part B: 750 µg romiplostim IV Q2W | Experimental | Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who complete Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase. Receives: Drug: Romiplostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants With Adverse Events
The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part A.
Measured: Treatment period (4 weeks) plus treatment extension (1 year)
Part B: Number of Participants With Adverse Events
The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part B.
Measured: Treatment period (8 weeks) plus treatment extension (1 year)
Secondary outcomes (15)
Part A: Number of Participants With a Complete or Major Platelet Response
Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.
Measured: Treatment Period (4 weeks)
Part B: Number of Participants With a Complete or Major Platelet Response
Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.
Measured: Treatment Period (8 weeks)
Part A: Number of Participants With a Platelet Response Per IWG Criteria
The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.
Measured: Treatment period (4 weeks) and extension period (52 weeks).
Part B: Number of Participants With a Platelet Response Per IWG
The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.
Measured: Treatment period (8 weeks) and extension period (52 weeks).
Part B: Peak Platelet Count
Peak platelet count (10^9/L) during the treatment period.
Measured: Treatment Period (8 weeks)
Part B: Time to First Platelet Response
Participants achieving first platelet response according to IWG criteria, by study week. Platelet response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks. Platelet counts obtained within 72 hours of platelet transfusion were not evaluable for platelet response.
Measured: Treatment Period (8 weeks) and extension period (52 weeks).
Part B: Duration of Platelet Response
Duration of platelet response per IWG criteria (absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks).
Measured: Treatment Period (8 weeks) and extension period (52 weeks)
Part B: Week 1 Cmax
Maximum observed serum concentration (Cmax) of romiplostim during Week 1
Measured: Week 1
Part B: Week 1 Ctrough
Measured romiplostim concentration at the end of the week 1 dosing interval (Ctrough)
Measured: Week 1
Part B: Week 1 AUC0-4
Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 1
Measured: Week 1
Part B: Week 7 Cmax
Maximum observed serum concentration (Cmax) of romiplostim during Week 7.
Measured: Week 7
Part B: Week 7 Ctrough
Measured romiplostim concentration at the end of the Week 7 dosing interval (Ctrough)
Measured: Week 7
Part B: Week 7 AUC0-4
Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 7.
Measured: Week 7
Part B: Week 1 Tmax
Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 1
Measured: Week 1
Part B: Week 7 Tmax
Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 7
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2008
- Study completionMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303472
- Sponsor's protocol ID
- 20050159
- Status last verified
- Nov 2013
- First submitted
- 16 Mar 2006
- Last updated
- 16 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Kantarjian H, Fenaux P, Sekeres MA, Becker PS, Boruchov A, Bowen D, Hellstrom-Lindberg E, Larson RA, Lyons RM, Muus P, Shammo J, Siegel R, Hu K, Franklin J, Berger DP. Safety and efficacy of romiplostim in patients with lower-risk myelodysplastic syndrome and thrombocytopenia. J Clin Oncol. 2010 Jan 20;28(3):437-44. doi: 10.1200/JCO.2009.24.7999. Epub 2009 Dec 14.
PubMed 20008626
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT00303472
- Acronym / sponsor ID
- 20050159
- Keywords
- MDS, Myelodysplastic Syndromes, Refractory Cytopenias, Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Posted 19 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A: 300 µg romiplostim | Experimental | Drug: RomiplostimCohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. |
| Part A: 700 µg romiplostim | Experimental | Drug: RomiplostimCohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. |
| Part A: 1000 µg romiplostim | Experimental | Drug: RomiplostimCohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. |
| Part A: 1500 µg romiplostim | Experimental | Drug: RomiplostimCohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. |
| Part B: 750 µg romiplostim SC QW | Experimental | Drug: RomiplostimPart B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who complete Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. |
| Part B: 750 µg romiplostim SC Q2W | Experimental | Drug: RomiplostimPart B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who complete Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase. |
| Part B: 750 µg romiplostim IV Q2W | Experimental | Drug: RomiplostimPart B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who complete Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of MDS using the World Health Organization classification
- Low or Intermediate-1 risk MDS using the International Prognostic Scoring System (IPSS)
- The mean of two platelet counts taken during the screening period must be ≤ 50 x 10^9/L, with no individual count > 55 x 10^9/L (The mean platelet counts of 5 subjects enrolled at the maximum tolerated dose (MTD) must be ≤ 20 x 10^9/L). Standard of care platelet assessments taken prior to Informed Consent may be used as 1 of the 2 counts taken within 3 weeks prior to study day 1.
- Must be ≥ 18 years of age at the time of obtaining informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the time of screening
Key exclusion criteria (22 listed)
- Currently receiving any treatment for MDS other than transfusions and erythropoietic growth factors. If granulocyte growth factors are currently being received, they cannot be used on or after study day 1
- Clinically significant bleeding within 2 weeks prior to screening (eg, gastrointestinal (GI) bleeds, intracranial hemorrhage)
- Prior malignancy (other than controlled prostate cancer, in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years before screening
- Prior history of bone marrow transplantation
- Persistent peripheral blood monocytosis (≥ 3 months with an absolute monocyte count > 1,000/µL)
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 |
|---|---|---|
| RomiplostimAlso: AMG 531, Nplate® | Drug | Part A: 1000 µg romiplostim, Part A: 1500 µg romiplostim, Part A: 300 µg romiplostim, Part A: 700 µg romiplostim, Part B: 750 µg romiplostim IV Q2W, Part B: 750 µg romiplostim SC Q2W, Part B: 750 µg romiplostim SC QW |
Primary outcome
Part A: Number of Participants With Adverse Events
Time frame: Treatment period (4 weeks) plus treatment extension (1 year)
The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part A.
Part B: Number of Participants With Adverse Events
Time frame: Treatment period (8 weeks) plus treatment extension (1 year)
The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part B.
15 secondary outcomes
Part A: Number of Participants With a Complete or Major Platelet Response
Time frame: Treatment Period (4 weeks)
Part B: Number of Participants With a Complete or Major Platelet Response
Time frame: Treatment Period (8 weeks)
Part A: Number of Participants With a Platelet Response Per IWG Criteria
Time frame: Treatment period (4 weeks) and extension period (52 weeks).
Part B: Number of Participants With a Platelet Response Per IWG
Time frame: Treatment period (8 weeks) and extension period (52 weeks).
Part B: Peak Platelet Count
Time frame: Treatment Period (8 weeks)
Part B: Time to First Platelet Response
Time frame: Treatment Period (8 weeks) and extension period (52 weeks).
Part B: Duration of Platelet Response
Time frame: Treatment Period (8 weeks) and extension period (52 weeks)
Part B: Week 1 Cmax
Time frame: Week 1
Part B: Week 1 Ctrough
Time frame: Week 1
Part B: Week 1 AUC0-4
Time frame: Week 1
Part B: Week 7 Cmax
Time frame: Week 7
Part B: Week 7 Ctrough
Time frame: Week 7
Part B: Week 7 AUC0-4
Time frame: Week 7
Part B: Week 1 Tmax
Time frame: Week 1
Part B: Week 7 Tmax
Time frame: Week 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20008626Kantarjian H, Fenaux P, Sekeres MA, Becker PS, Boruchov A, Bowen D, Hellstrom-Lindberg E, Larson RA, Lyons RM, Muus P, Shammo J, Siegel R, Hu K, Franklin J, Berger DP. Safety and efficacy of romiplostim in patients with lower-risk myelodysplastic syndrome and thrombocytopenia. J Clin Oncol. 2010 Jan 20;28(3):437-44. doi: 10.1200/JCO.2009.24.7999. Epub 2009 Dec 14.
- AmgenTrials clinical trials 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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Romiplostim in people with Thrombocytopenia and MDS, run by Amgen.
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 8 inclusion and 22 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 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 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?
Part A: Number of Participants With Adverse Events (time frame: Treatment period (4 weeks) plus treatment extension (1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00303472, which also lists 1 linked publication.
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 16 Dec 2013.