Advanced Non-small Cell Lung CancerPhase 2NCT01240447
Immunotherapy With Racotumomab Versus Support Treatment in Advanced Non-small Cell Lung Cancer Patients
A Phase 2 study testing racotumomab and Best support treatment in people with Advanced Non-small Cell Lung Cancer, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
Trial summary
This study is designed to evaluate safety and immunogenicity of racotumomab in patients with advanced Non-small Cell Lung Cancer (NSCLC), in concomitance with chemotherapy (docetaxel) when a second-line therapy is indicated. The study will also compare survival and progression free survival on both study arms. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- racotumomab and Best support treatment
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteArgentina
- Study dates
- Sep 2009to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient (aged over 21 years, either sex) can comply with the protocol and scheduled appointments and sign voluntarily the informed consent form
- Diagnosis of Non-small cell lung cancer (NSCLC) stages IIIA (surgically unresectable), IIIB or IV, according to the TNM classification (Tumor-Nodes-Metastases) version 6a, confirmed by cytology or histology, if possible available for determination of ganglioside expression
- Patients may enter the study if they have accomplished an objective response (complete response or partial response) or disease stabilisation (by Response Evaluation Criteria In Solid Tumours [RECIST]) after completion of standard onco-specific treatment. In all cases, response should be documented.
- For stage IIIA and IIIB without pleural effusion ("dry IIIB") standard treatment is considered as follows: 2 - 4 cycles of platinum-based chemotherapy and/or radiotherapy with curative intent in accordance with National Comprehensive Cancer Network (NCCN) guidelines For stage IIIB with pleural effusion ("wet IIIB") and stage IV standard treatment is considered as follows: 4 - 6 cycles of chemotherapy based on platinum. In case of pleural or pericardial effusion requiring local treatment, it will be provided prior to study entry.
- Patients with an interval greater than 30 and not more than 90 days between the completion of oncospecific treatment and study entry. Completion of treatment is defined as the last day of administration of chemotherapy or the last day of radiotherapy. Patients should have recovered from any related episode of acute toxicity of degree greater than 1 (except alopecia). Patients who have received a monoclonal antibody (eg bevacizumab) should also have discontinued its use for at least 30 days before inclusion.
- The subject is male or female, aged greater than or equal to 21 years
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- Performance status (Eastern Cooperative Oncology Group [ECOG]) less than or equal to 1
- Acceptable organ functionality as defined by the following parameters:
- Electrocardiogram (ECG) without significant abnormalities, performed within 14 days prior to admission
- Haemoglobin greater than or equal to 90 g/L
- Total leukocyte count greater than or equal to 3.0 x 10^9/L
- Absolute neutrophil count greater than or equal to 1.5 x 10^9/L
- Total bilirubin less than or equal to 1.5 times upper limit of normal or twice the limit normal than in case liver metastases are present
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 times upper limit of normal (less than or equal to five times the normal maximum in case liver metastases are present)
- Creatinine less than or equal to 2 mg/dL
- Life expectancy of at least four months
Who cannot join
- Patient is pregnant or breastfeeding
- Has received chemotherapy, radiotherapy, immunotherapy or surgery within 30 days prior to inclusion
- Hypersensitivity to any component of the formulation
- Patients of childbearing potential of either sex who are not using an adequate method of contraception during treatment to avoid pregnancy (own or of partner). For females: intrauterine devices, hormonal contraceptives, barrier methods or sterilisation. For males: vasectomy or condoms with spermicide.
- Patients receiving or having received other investigational drugs 30 days prior to study entry
- History of autoimmune diseases
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- Decompensated chronic diseases
- Acute allergic disorders or history of severe allergic reactions
- Known brain metastases uncontrolled with surgery and/or radiation therapy or under current corticosteroid therapy
- History of inflammatory or demyelinating disease of the central or peripheral nervous system
- Uncontrolled intercurrent illnesses, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric diseases implying patient incompetence
- Other malignancies, with the exception of basal cell carcinoma, in situ cervical carcinoma, incidental prostate cancer (T1a, Gleason less than or equal to 6, prostate specific antigen [PSA] less than 0.5 ng/ml), tumour or any other tumour adequately treated and with a disease-free period greater than or equal to 5 years
- Chronic treatment with systemic corticosteroids at doses greater than 0.5 mg/kg/day or a maximum of 40 mg/day of prednisone or equivalent
- The subject has a history of drug abuse (illicit drugs) or alcohol abuse (defined as regular or periodic ingestion of more than four drinks a day) in the last 2 years
- Positive serology for hepatitis B, C or known human immunodeficiency virus (HIV) infection
- Uncontrolled hypercalcaemia greater than or equal to 2.9 mmol/L (or grade greater than 1 according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Instituto de Oncología "Angel H. Roffo"
Buenos Aires, Buenos Aires, C1417DTB
About this study
Official title: A Prospective, Randomised, Open Label Phase II Study of Active Specific Immunotherapy With Racotumomab Versus Support Treatment in Patients With Advanced Non-small Cell Lung Cancer
This study is designed to evaluate safety and immunogenicity of racotumomab in patients with advanced Non-small Cell Lung Cancer (NSCLC), in concomitance with chemotherapy (docetaxel) when a second-line therapy is indicated. The study will also compare survival and progression free survival on both study arms.
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- racotumomab, Best support treatment
- Keywords
- NSCLC, lung cancer, small-cell, advanced lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
racotumomabBiological
Also called 1E10
Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), subcutaneously, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and a second line therapy is indicated, the patient will only be able to continue in the study if the drug indicated is docetaxel. Vaccination will not be interrupted during docetaxel administration unless criteria for vaccine discontinuation are met.
Best support treatmentOther
Patients will receive best support treatment as indicated by the investigator. In case a second line therapy is indicated, docetaxel is the only drug allowed to continue in the study.
| Study group | Role | What they receive |
|---|---|---|
| Best support treatment | Other | Not described Receives: Other: Best support treatment |
| Racotumomab vaccine | Experimental | Not described Receives: Biological: racotumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse events as a measure of safety and tolerability
Safety will be evaluated at each study visit according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and will include physical examination with vital signs, performance status as per the Eastern Cooperative Oncology Group scale(ECOG scale), laboratory tests and clinical history.
Measured: Until death, on average during 17 months
Evaluation of the reactivity if the antibodies against X63 tumor line
Measured: Baseline
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Measured: Baseline
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Measured: Baseline
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Measured: Baseline
Measurement of pro-inflammatory and anti-inflammatory cytokines
Measured: Baseline
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Measured: Month 2
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Measured: Month 4
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Measured: Month 8
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Measured: Month 12
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Measured: Baseline
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Measured: Month 2
Measurement of pro-inflammatory and anti-inflammatory cytokines.
Measured: Baseline
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Measured: Month 2
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Measured: Month 8
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Measured: Month 4
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Measured: Month 12
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Measured: Every 4 months (after the first year, on average during 17 months)
Evaluation of the reactivity if the antibodies against X63 tumor line
Measured: Month 2
Evaluation of the reactivity if the antibodies against X63 tumor line
Measured: Month 12
Evaluation of the reactivity if the antibodies against X63 tumor line
Measured: Every 4 months (after the first year, on average during 17 months)
Evaluation of the reactivity if the antibodies against X63 tumor line
Measured: Month 4
Evaluation of the reactivity if the antibodies against X63 tumor line
Measured: Month 8
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Measured: Month 4
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Measured: Month 8
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Measured: Month 12
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Measured: Every 4 months (after the first year, on average during 17 months)
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Measured: Month 2
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Measured: Month 4
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Measured: Month 8
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Measured: Month 12
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Measured: Every 4 months (after the first year, on average during 17 months)
Measurement of pro-inflammatory and anti-inflammatory cytokines
Measured: Month 2
Measurement of pro-inflammatory and anti-inflammatory cytokines
Measured: Month 4
Measurement of pro-inflammatory and anti-inflammatory cytokines
Measured: Month 8
Measurement of pro-inflammatory and anti-inflammatory cytokines
Measured: Month 12
Measurement of pro-inflammatory and anti-inflammatory cytokines
Measured: Every 4 months (after the first year, on average during 17 months)
Secondary outcomes (2)
Survival
On average, during 17 months
Measured: Until date of death or last censored observation
Progression free survival
Tumour evaluations will be performed every 2 months and evaluated as per Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Until first progression of disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Elea Phoenix S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriela Cinat, MD, Principal investigator, Instituto de Oncología "Angel H. Roffo"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240447
- Sponsor's protocol ID
- AR-RACO-02-08
- Other IDs
- ISRCTN47153584
- Status last verified
- Jul 2014
- First submitted
- 23 Sep 2010
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Open Label Phase II Study of Active Specific Immunotherapy With Racotumomab Versus Support Treatment in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01240447
- Acronym / sponsor ID
- AR-RACO-02-08
- Conditions
- Advanced Non-small Cell Lung Cancer
- Keywords
- NSCLC, lung cancer, small-cell, advanced lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Laboratorio Elea Phoenix S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Nov 2010 (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.
This study is designed to evaluate safety and immunogenicity of racotumomab in patients with advanced Non-small Cell Lung Cancer (NSCLC), in concomitance with chemotherapy (docetaxel) when a second-line therapy is indicated. The study will also compare survival and progression free survival on both study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best support treatment | Other | Other: Best support treatment |
| Racotumomab vaccine | Experimental | Biological: racotumomab |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The patient (aged over 21 years, either sex) can comply with the protocol and scheduled appointments and sign voluntarily the informed consent form
- Diagnosis of Non-small cell lung cancer (NSCLC) stages IIIA (surgically unresectable), IIIB or IV, according to the TNM classification (Tumor-Nodes-Metastases) version 6a, confirmed by cytology or histology, if possible available for determination of ganglioside expression
- Patients may enter the study if they have accomplished an objective response (complete response or partial response) or disease stabilisation (by Response Evaluation Criteria In Solid Tumours [RECIST]) after completion of standard onco-specific treatment. In all cases, response should be documented.
- For stage IIIA and IIIB without pleural effusion ("dry IIIB") standard treatment is considered as follows: 2 - 4 cycles of platinum-based chemotherapy and/or radiotherapy with curative intent in accordance with National Comprehensive Cancer Network (NCCN) guidelines For stage IIIB with pleural effusion ("wet IIIB") and stage IV standard treatment is considered as follows: 4 - 6 cycles of chemotherapy based on platinum. In case of pleural or pericardial effusion requiring local treatment, it will be provided prior to study entry.
- Patients with an interval greater than 30 and not more than 90 days between the completion of oncospecific treatment and study entry. Completion of treatment is defined as the last day of administration of chemotherapy or the last day of radiotherapy. Patients should have recovered from any related episode of acute toxicity of degree greater than 1 (except alopecia). Patients who have received a monoclonal antibody (eg bevacizumab) should also have discontinued its use for at least 30 days before inclusion.
Key exclusion criteria (16 listed)
- Patient is pregnant or breastfeeding
- Has received chemotherapy, radiotherapy, immunotherapy or surgery within 30 days prior to inclusion
- Hypersensitivity to any component of the formulation
- Patients of childbearing potential of either sex who are not using an adequate method of contraception during treatment to avoid pregnancy (own or of partner). For females: intrauterine devices, hormonal contraceptives, barrier methods or sterilisation. For males: vasectomy or condoms with spermicide.
- Patients receiving or having received other investigational drugs 30 days prior to study entry
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 |
|---|---|---|
| racotumomabAlso: 1E10Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), subcutaneously, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and a second line therapy is indicated, the patient will only be able to continue in the study if the drug indicated is docetaxel. Vaccination will not be interrupted during docetaxel administration unless criteria for vaccine discontinuation are met. | Biological | Racotumomab vaccine |
| Best support treatmentPatients will receive best support treatment as indicated by the investigator. In case a second line therapy is indicated, docetaxel is the only drug allowed to continue in the study. | Other | Best support treatment |
Primary outcome
Number of Participants with Adverse events as a measure of safety and tolerability
Time frame: Until death, on average during 17 months
Safety will be evaluated at each study visit according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and will include physical examination with vital signs, performance status as per the Eastern Cooperative Oncology Group scale(ECOG scale), laboratory tests and clinical history.
Evaluation of the reactivity if the antibodies against X63 tumor line
Time frame: Baseline
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Time frame: Baseline
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Time frame: Baseline
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Time frame: Baseline
Measurement of pro-inflammatory and anti-inflammatory cytokines
Time frame: Baseline
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Time frame: Month 2
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Time frame: Month 4
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Time frame: Month 8
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.
Time frame: Month 12
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Time frame: Baseline
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Time frame: Month 2
Measurement of pro-inflammatory and anti-inflammatory cytokines.
Time frame: Baseline
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Time frame: Month 2
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Time frame: Month 8
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Time frame: Month 4
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Time frame: Month 12
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside
Time frame: Every 4 months (after the first year, on average during 17 months)
Evaluation of the reactivity if the antibodies against X63 tumor line
Time frame: Month 2
Evaluation of the reactivity if the antibodies against X63 tumor line
Time frame: Month 12
Evaluation of the reactivity if the antibodies against X63 tumor line
Time frame: Every 4 months (after the first year, on average during 17 months)
Evaluation of the reactivity if the antibodies against X63 tumor line
Time frame: Month 4
Evaluation of the reactivity if the antibodies against X63 tumor line
Time frame: Month 8
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Time frame: Month 4
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Time frame: Month 8
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Time frame: Month 12
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)
Time frame: Every 4 months (after the first year, on average during 17 months)
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Time frame: Month 2
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Time frame: Month 4
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Time frame: Month 8
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Time frame: Month 12
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.
Time frame: Every 4 months (after the first year, on average during 17 months)
Measurement of pro-inflammatory and anti-inflammatory cytokines
Time frame: Month 2
Measurement of pro-inflammatory and anti-inflammatory cytokines
Time frame: Month 4
Measurement of pro-inflammatory and anti-inflammatory cytokines
Time frame: Month 8
Measurement of pro-inflammatory and anti-inflammatory cytokines
Time frame: Month 12
Measurement of pro-inflammatory and anti-inflammatory cytokines
Time frame: Every 4 months (after the first year, on average during 17 months)
2 secondary outcomes
Survival
Time frame: Until date of death or last censored observation
Progression free survival
Time frame: Until first progression of disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
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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.
Gabriela Cinat, MD principal investigator
Instituto de Oncología "Angel H. Roffo"
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 racotumomab and Best support treatment in people with Advanced Non-small Cell Lung Cancer, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
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 16 inclusion and 16 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 10 Jul 2014. 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 Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse events as a measure of safety and tolerability (time frame: Until death, on average during 17 months). The study lists 37 primary outcomes in all. 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 10 Jul 2014.