Prostate CancerPhase 3NCT01234311
A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
A Phase 3 study testing tasquinimod in people with Prostate Cancer, run by Active Biotech AB at 204 sites in 37 countries.
Trial summary
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- tasquinimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,245 participants
- Where
- 204 sitesin 37 countries
- Study dates
- Mar 2011to Aug 2015
- Phase
- Phase 3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years at the time of signing the informed consent form. For patients in Taiwan the minimum age is 20 years.
- Histologically confirmed diagnosis of adenocarcinoma of the prostate.
- Evidence of bone metastatic disease on radiographic examination, whether from bone scan or other imaging modality.
- Castrate levels of serum testosterone (≤50 ng/dL or 1.7 nmol/L).
- Evidence of progressive disease.
- Karnofsky score ≥70%.
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- Meet screening laboratory values as specified in thr protocol.
- If sexually active with partner of childbearing potential, patient will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug. The adequate contraceptive method should be continued for 14 days after the patient stops taking study drug.
- No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
- Able to swallow and retain oral medication.
- Able to adhere to the study visit schedule and other protocol requirements.
- Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study.
- Able (or patient's legal guardian, if applicable) to sign and date the written informed consent after being informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information.
Who cannot join
- Prior cytotoxic chemotherapy for the treatment of prostate ca within 2 years or within 4 weeks for Estracyt (estramustine) prior to study treatment.
- Previous anticancer therapy using radiation, biologics or vaccines, including abiraterone, TAK-700 (Orteronel), or MDV3100 within 4 weeks prior or sipuleucel-T (Provenge) within 2 weeks prior to the start of study treatment. If radiation therapy is applied after baseline scan, a new baseline scan needs to be done at least 4 weeks after the radiation therapy.
- Previous therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide eg, Casodex®) prior to study treatment.
- Concurrent use of other anticancer agents or treatments, with the following exceptions:
- Ongoing treatment with luteinizing hormone-releasing hormone agonists or antagonists, denosumab (Prolia) or bisphosphonate (eg, zoledronic acid) is allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed.
- Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
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- Prostate ca pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy.
- Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 (Section 4.6.8.1).
- Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.
- Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone is not allowed within 1 year prior to the start of study treatment.
- Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.
- Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.
- Simultaneous participation in any other study involving treatment with investigational drugs or having received treatment with investigational drugs less than 4 weeks prior to the start of study treatment.
- Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or limb claudication at rest, within 6 months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and uncontrolled atrial or ventricular arrhythmias.
- History of pancreatitis.
- Known brain or epidural metastases.
- Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
- Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients who have recovered from hepatitis will be allowed to enter the study).
- Patients with active tuberculosis (TB), or with known, untreated latent TB. (Country-specific TB therapy should have been given for at least 30 days prior to the start of study treatment and the patient should intend to complete the entire course of that therapy.)
- Any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
- Any patient who in the opinion of the investigator should not participate
Trial locations and contacts
204 sites in 37 countries.
204 sites in 37 countries
United States34 sites
Study site
Atlanta, Georgia
Study site
Bala-Cynwyd, Pennsylvania
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Burien, Washington
Study site
Concord, North Carolina
Study site
Dallas, Texas
Study site
Durham, North Carolina
Study site
Fairfax, Virginia
Study site
Hackensack, New Jersey
Study site
Jefferson City, Missouri
Study site
Jeffersonville, Indiana
Study site
Lancaster, Pennsylvania
Study site
Las Vegas, Nevada
Study site
Lawrenceville, New Jersey
Study site
Melrose Park, Illinois
Study site
Meridian, Idaho
Study site
Myrtle Beach, South Carolina
Study site
Nashville, Tennessee
Study site
Norfolk, Virginia
Study site
Oxnard, California
Study site
Park Ridge, Illinois
Study site
Pittsburgh, Pennsylvania
Study site
Poughkeepsie, New York
Study site
Raleigh, North Carolina
Study site
Rockville, Maryland
Study site
Salem, Virginia
Study site
Salt Lake City, Utah
Study site
Santa Monica, California
Study site
Santa Rosa, California
Study site
Springfield, Oregon
Study site
Tucson, Arizona
Study site
Wellington, Florida
Brazil13 sites
Study site
Botucatu, Sao Paulo
Study site
Cachoeiro de Itapemirim - ES
Study site
Curitiba, Parana
Study site
Florianópolis
Study site
Juiz de Fora, Minas Gerais
Study site
Mogi Das Cruzes, Sao Paulo
Study site
Natal, Rio Grande Do Norte
Study site
Passo Fundo
Study site
Porto Alegre, RS
Study site
Rio de Janeiro
Study site
Salvador/BA
Study site
São Paulo
Study site
Volta Redonda - RJ
Ukraine11 sites
Study site
Chernivtsi
Study site
Dnipropetrovsk
Study site
Donetsk
Study site
Ivano-Frankivsk
Study site
Kharkiv
Study site
Kyiv
Study site
Lutsk
Study site
Lviv
Study site
Odesa
Study site
Uzhhorod
Study site
Zaporizhzhya
Germany10 sites
Study site
Cologne
Study site
Dresden
Study site
Hamburg
Study site
Mannheim
Study site
Marburg
Study site
München
Study site
Münster
Study site
Nürtingen
Study site
Tübingen
Study site
Weiden
Spain10 sites
Study site
Alcorcón, Madrid, Communidad de
Study site
Barcelona
Study site
Oviedo, Principality of Asturias
Study site
Pamplona, Navarre
Study site
Sabadell, Catalonia
Study site
San Sebastián de los Reyes
Study site
Santander, Cantabria
Study site
Seville, Andalusia
Study site
Valencia
Study site
Zaragoza, Aragon
United Kingdom9 sites
Study site
Birmingham
Study site
Chichester
Study site
Leeds
Study site
London
Study site
Northwood
Study site
Nottingham
Study site
Oxford
Study site
Scunthorpe
Study site
Sutton
France8 sites
Study site
Angers
Study site
Cannes
Study site
Marseille
Study site
Montpellier
Study site
Paris
Study site
Pierre-Bénite
Study site
Rennes
Study site
Suresnes
Italy8 sites
Study site
Cremona
Study site
Lecco
Study site
Meldola
Study site
Milan
Study site
Padova
Study site
Ravenna
Study site
Roma
Study site
Torino
Israel7 sites
Study site
Beersheba
Study site
Haifa
Study site
Jerusalem
Study site
Petah Tikva
Study site
Ramat Gan
Study site
Tel Aviv
Study site
Tsrifin
Romania7 sites
Study site
Baia Mare
Study site
Bucharest
Study site
Cluj-Napoca
Study site
Craiova
Study site
Ploieşti
Study site
Suceava
Study site
Timișoara
Australia6 sites
Study site
Camperdown, New South Wales
Study site
Coffs Harbour, New South Wales
Study site
Darlinghurst, New South Wales
Study site
Richmond, Victoria
Study site
Subiaco, Western Australia
Study site
Tweed Heads, New South Wales
Poland6 sites
Study site
Bialystok
Study site
Lodz
Study site
Mysłowice
Study site
Poznan
Study site
Warsaw
Study site
Wroclaw
Russia6 sites
Study site
Moscow
Study site
Novosibirsk
Study site
Omsk
Study site
Saint Petersburg
Study site
Vladimir
Study site
Yekaterinburg
Canada5 sites
Study site
Brantford, Ontario
Study site
Kelowna, British Columbia
Study site
North York, Ontario
Study site
Oakville, Ontario
Study site
Victoria, British Columbia
China5 sites
Study site
Beijing
Study site
Chengdu
Study site
Shanghai
Study site
Shantou
Study site
Wuhan
Mexico5 sites
Study site
Chihuahua, Chih.
Study site
Culiacan, Sinaloa
Study site
Leon, GTO
Study site
Puebla City
Study site
Zapopan, Jalisco
Netherlands5 sites
Study site
Amsterdam
Study site
Groningen
Study site
Leiden
Study site
Nijmegen
Study site
Tilburg
Belgium4 sites
Study site
Brussels
Study site
Ghent
Study site
Kortrijk
Study site
Liège
Bulgaria4 sites
Study site
Pleven
Study site
Plovdiv
Study site
Sofia
Study site
Varna
Czechia4 sites
Study site
Nový Jičín
Study site
Olomouc
Study site
Prague
Study site
Ústí nad Labem
New Zealand4 sites
Study site
Christchurch
Study site
Nelson
Study site
Palmerston North
Study site
Tauranga
Taiwan4 sites
Study site
Kaohsiung City
Study site
Taichung
Study site
Taipei
Study site
Taoyuan
Argentina3 sites
Study site
Buenos Aires
Study site
Santa Rosa
Study site
Venado Tuerto
About this study
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo.
Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).
Read the detailed description
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo.
Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).
- Conditions
- Prostate Cancer
- Being tested
- tasquinimod, Placebo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tasquinimodDrug
Also called ABR-215050
Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
| tasquinimod | Experimental | Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule) Receives: Drug: tasquinimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer
The primary endpoint is progression-free survival (PFS) defined as the time from the date of randomization to the date of radiological progression or death.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionFeb 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Active Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael A Carducci, MD, Principal investigator, Johns Hopkins Kimmel Cancer Center, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234311
- Sponsor's protocol ID
- 10TASQ10
- Status last verified
- Oct 2015
- First submitted
- 1 Nov 2010
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Armstrong AJ, Anand A, Edenbrandt L, Bondesson E, Bjartell A, Widmark A, Sternberg CN, Pili R, Tuvesson H, Nordle O, Carducci MA, Morris MJ. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):944-951. doi: 10.1001/jamaoncol.2018.1093.
PubMed 29799999Sternberg C, Armstrong A, Pili R, Ng S, Huddart R, Agarwal N, Khvorostenko D, Lyulko O, Brize A, Vogelzang N, Delva R, Harza M, Thanos A, James N, Werbrouck P, Bogemann M, Hutson T, Milecki P, Chowdhury S, Gallardo E, Schwartsmann G, Pouget JC, Baton F, Nederman T, Tuvesson H, Carducci M. Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2016 Aug 1;34(22):2636-43. doi: 10.1200/JCO.2016.66.9697. Epub 2016 Jun 13.
PubMed 27298414
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01234311
- Acronym / sponsor ID
- 10TASQ10
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,245 participants (actual)
- Lead sponsor
- Active Biotech ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 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 is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo.
Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).
Detailed description
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo.
Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboMatching placebo |
| tasquinimod | Experimental | Drug: tasquinimodTasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age at least 18 years at the time of signing the informed consent form. For patients in Taiwan the minimum age is 20 years.
- Histologically confirmed diagnosis of adenocarcinoma of the prostate.
- Evidence of bone metastatic disease on radiographic examination, whether from bone scan or other imaging modality.
- Castrate levels of serum testosterone (≤50 ng/dL or 1.7 nmol/L).
- Evidence of progressive disease.
Key exclusion criteria (21 listed)
- Prior cytotoxic chemotherapy for the treatment of prostate ca within 2 years or within 4 weeks for Estracyt (estramustine) prior to study treatment.
- Previous anticancer therapy using radiation, biologics or vaccines, including abiraterone, TAK-700 (Orteronel), or MDV3100 within 4 weeks prior or sipuleucel-T (Provenge) within 2 weeks prior to the start of study treatment. If radiation therapy is applied after baseline scan, a new baseline scan needs to be done at least 4 weeks after the radiation therapy.
- Previous therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide eg, Casodex®) prior to study treatment.
- Concurrent use of other anticancer agents or treatments, with the following exceptions:
- Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
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 |
|---|---|---|
| tasquinimodAlso: ABR-215050Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule) | Drug | tasquinimod |
| Placebo | Drug | placebo |
Primary outcome
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer
Time frame: 5 years
The primary endpoint is progression-free survival (PFS) defined as the time from the date of randomization to the date of radiological progression or death.
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 21 Oct 2015.
- Derived from this study: PubMed 29799999Armstrong AJ, Anand A, Edenbrandt L, Bondesson E, Bjartell A, Widmark A, Sternberg CN, Pili R, Tuvesson H, Nordle O, Carducci MA, Morris MJ. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):944-951. doi: 10.1001/jamaoncol.2018.1093.
- Derived from this study: PubMed 27298414Sternberg C, Armstrong A, Pili R, Ng S, Huddart R, Agarwal N, Khvorostenko D, Lyulko O, Brize A, Vogelzang N, Delva R, Harza M, Thanos A, James N, Werbrouck P, Bogemann M, Hutson T, Milecki P, Chowdhury S, Gallardo E, Schwartsmann G, Pouget JC, Baton F, Nederman T, Tuvesson H, Carducci M. Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2016 Aug 1;34(22):2636-43. doi: 10.1200/JCO.2016.66.9697. Epub 2016 Jun 13.
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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.
Michael A Carducci, MD principal investigator
Johns Hopkins Kimmel Cancer Center, Baltimore, MD
204 sites in 37 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tasquinimod in people with Prostate Cancer, run by Active Biotech AB at 204 sites in 37 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 204 sites in United States, Brazil, Ukraine, Germany, Spain and 32 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer (time frame: 5 years). 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 NCT01234311, which also lists 2 linked publications.
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 21 Oct 2015.