Non-Small Cell Lung CancerPhase 1NCT00787852
A Study of Dasatinib With Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47 and Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38 in people with Non-Small Cell Lung Cancer, run by Brown University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if a maximum dose of 100 mg of dasatinib with concurrent chemoradiation can be tolerated in patients with chemotherapy naive stage III NSCLC in separate cohorts of locally advanced and potentially resectable disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47 and Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2011
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, [according to AJCC Staging, 6th edition; see Appendix G] within 4 weeks of registration.
- No prior chemotherapy or radiation for lung cancer. No prior radiation for any malignancy within the radiation field.
- Patients may be potentially resectable or unresectable.
- Stage III A or B disease, including no distant metastases- based on following diagnostic workup:
- History/physical examination prior to registration.
- CT Scan of the chest or Pet Scan within 28 days of study entry.
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- CT Scan of abdomen or MRI of abdomen or Pet Scan within 28 days of study entry.
- An MRI of the brain or Head CT Scan with contrast within 28 days of study entry.
- Total body PET scan within 6 weeks of study entry is highly recommended and required for operable patients. If a PET scan is performed then a bone scan is not required.
- A bone scan should be performed within 6 weeks of study entry. A bone scan is not needed if a PET scan is performed.
- Mediastinoscopies are highly recommended. Mediastinoscopy is required for all patients not undergoing PET scans and for those who are operable.
- Patients must have measurable or evaluable disease.
- Patients with post-obstructive pneumonia are eligible.
- Patients must be at least 3 weeks from prior thoracotomy (if performed)
- ECOG Performance Status 0-1. Age > 18.
- Post-op predicted FEV1 > 40% to be eligible for surgical resection.
- CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) > 1,500 cells/ul.
- Platelets > 100,000 cells/ul.
- Hemoglobin > 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > g/dl is acceptable.)
- PT, PTT all Grade 0-1
- Serum creatinine < 1.5 x ULN
- Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
- AST and ALT < 2.5 x the ULN
- Serum Na, K+, Mg2+, Phosphate in normal range (LLN)
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration.
- Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- If you are capable of giving birth to or fathering a child, you must agree to use a form of birth control (examples of effective birth control are: a condom or a diaphragm with spermicidal jelly; oral, injectable, or implanted birth control; or abstinence) that is medically acceptable to your study doctor while taking part in this research study. This is necessary because the treatment involved in this study may be significantly teratogenic.
- PFT's within 8 weeks of study entry
- EKG within 6 weeks of study entry
- Ability to take oral medication (dasatinib must be swallowed whole)
- Patient must sign study specific informed consent prior to study entry.
- Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib)
Who cannot join
- Supraclavicular disease
- Pleural or pericardial effusion of any grade
- No prior malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 3 years
- Severe, active co-morbidity, defined as follows:
- Cardiac Symptoms; any of the following should be considered for exclusion:
- Uncontrolled angina, congestive heart failure or MI within (6 months)
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- Diagnosed congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
- Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Protocol-specific requirements may also exclude immuno-compromised patients
- History of significant bleeding disorder unrelated to cancer, including:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).
- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).
- Ongoing or recent (< 3 months) significant gastrointestinal bleeding
- Concomitant Medications, any of the following should be considered for exclusion:
- Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib):
- quinidine, procainamide, disopyramide
- amiodarone, sotalol, ibutilide, dofetilide
- erythromycin, clarithromycin
- chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
- Women who:are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding
- Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin.
- Uncontrolled neuropathy grade 2 or greater regardless of cause.
- Patients who are on full dose aspirin, Clopidogrel bisulfate (plavix) or other GPIIb/IIIa platelet inhibitors are not eligible. Patients must have these agents stopped within 7 days of initiated treatment. Patients may be on low dose aspirin (81 mg/day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Dasatinib With Concurrent Chemoradiation for Stage III NSCLC Principal Investigator: Howard Safran, MD.
The purpose of this study is to evaluate if a maximum dose of 100 mg of dasatinib with concurrent chemoradiation can be tolerated in patients with chemotherapy naive stage III NSCLC in separate cohorts of locally advanced and potentially resectable disease.
Read the detailed description
Describe the safety of maintenance dasatinib, 100 mg/day for 2 years, in patients with stage III NSCLC.
For patients with potentially resectable disease, to assess the pathologic complete response following neoadjuvant dasatinib, paclitaxel, carboplatin and 50.4 Gy concurrent radiation.
For patients with locally unresectable disease, to obtain radiographic response data following dasatinib, paclitaxel, carboplatin and 64.8 Gy radiation.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47, Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38
- Keywords
- dasatinib, radiation, paclitaxel, carboplatin, NSCLC, safety addition of dasatinib to chemo RT stage III NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47Drug
Also called Group 1: Locally Advanced Stage III NSCLC
Locally Advanced Stage III NSCLC DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43
Dasatinib is to be taken 1x daily
- 50 mg daily 100 mg daily
- 70 mg daily 100 mg daily
- 100 mg daily 100 mg daily
Maintenance x 2 years*
Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38Drug
Also called Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC
Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36
Dasatinib is to be taken 1x daily
- 50 mg daily 100 mg daily
- 70 mg daily 100 mg daily
- 100 mg daily 100 mg daily Maintenance x 2 years*
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Radiation, Paclitaxel, Carbo, Dasatinib days 1-47 | Experimental | Locally Advanced Stage III NSCLC DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43
Dasatinib is to be taken 1x daily
1. 50 mg daily 100 mg daily
2. 70 mg daily 100 mg daily
3. 100 mg daily 100 mg daily
Maintenance x 2 years* Receives: Drug: Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47 |
| Group 2: Radiation, Paclitaxel, carbo, Dasatinib days 1-38 | Experimental | Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36
Dasatinib is to be taken 1x daily
1. 50 mg daily 100 mg daily
2. 70 mg daily 100 mg daily
3. 100 mg daily 100 mg daily Maintenance x 2 years* Receives: Drug: Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Came Off Study for Toxicity Using CTC Version 3.0
6 patients came off study for toxicity
Measured: within 28 days after the last radiation treatment
Secondary outcomes (1)
Complete and Partial Response by CT Scan or MRI
Measured: within 30 days of last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionDec 2011
Why it stopped: for efficacy and safety reasons
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 Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, Memorial Hospital of Rhode Island
- Responsible party
- Principal investigator, howard safran, Brown University
- Investigators
- Howard Safran, md, Study director, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787852
- Sponsor's protocol ID
- BrUOG-NSCL-216
- Status last verified
- Jul 2014
- First submitted
- 7 Nov 2008
- Last updated
- 30 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Dasatinib With Concurrent Chemoradiation for Stage III NSCLC Principal Investigator: Howard Safran, MD.
- ClinicalTrials.gov ID
- NCT00787852
- Acronym / sponsor ID
- BrUOG-NSCL-216
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- dasatinib, radiation, paclitaxel, carboplatin, NSCLC, safety addition of dasatinib to chemo RT stage III NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: for efficacy and safety reasons
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, Memorial Hospital of Rhode Island
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Posted 25 Sep 2013
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 if a maximum dose of 100 mg of dasatinib with concurrent chemoradiation can be tolerated in patients with chemotherapy naive stage III NSCLC in separate cohorts of locally advanced and potentially resectable disease.
Detailed description
Describe the safety of maintenance dasatinib, 100 mg/day for 2 years, in patients with stage III NSCLC.
For patients with potentially resectable disease, to assess the pathologic complete response following neoadjuvant dasatinib, paclitaxel, carboplatin and 50.4 Gy concurrent radiation.
For patients with locally unresectable disease, to obtain radiographic response data following dasatinib, paclitaxel, carboplatin and 64.8 Gy radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Radiation, Paclitaxel, Carbo, Dasatinib days 1-47 | Experimental | Drug: Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47Locally Advanced Stage III NSCLC DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years* |
| Group 2: Radiation, Paclitaxel, carbo, Dasatinib days 1-38 | Experimental | Drug: Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years* |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, [according to AJCC Staging, 6th edition; see Appendix G] within 4 weeks of registration.
- No prior chemotherapy or radiation for lung cancer. No prior radiation for any malignancy within the radiation field.
- Patients may be potentially resectable or unresectable.
- Stage III A or B disease, including no distant metastases- based on following diagnostic workup:
- Patients must have measurable or evaluable disease.
Key exclusion criteria (28 listed)
- Supraclavicular disease
- Pleural or pericardial effusion of any grade
- No prior malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 3 years
- Severe, active co-morbidity, defined as follows:
- Cardiac Symptoms; any of the following should be considered for exclusion:
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 |
|---|---|---|
| Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47Also: Group 1: Locally Advanced Stage III NSCLCLocally Advanced Stage III NSCLC DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years* | Drug | Group 1: Radiation, Paclitaxel, Carbo, Dasatinib days 1-47 |
| Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38Also: Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLCGroup 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36 Dasatinib is to be taken 1x daily 1. 50 mg daily 100 mg daily 2. 70 mg daily 100 mg daily 3. 100 mg daily 100 mg daily Maintenance x 2 years* | Drug | Group 2: Radiation, Paclitaxel, carbo, Dasatinib days 1-38 |
Primary outcome
Number of Patients Who Came Off Study for Toxicity Using CTC Version 3.0
Time frame: within 28 days after the last radiation treatment
6 patients came off study for toxicity
1 secondary outcome
Complete and Partial Response by CT Scan or MRI
Time frame: within 30 days of last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Howard Safran, md study director
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group 1: Radiation, Paclitaxel,Carbo, Dasatinib days 1-47 and Group 2: Radiation, Paclitaxel, Carbo, Dasatinib days 1-38 in people with Non-Small Cell Lung Cancer, run by Brown University 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 33 inclusion and 28 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: stopped early, as of the sponsor's last update on 30 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 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2013). 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 Who Came Off Study for Toxicity Using CTC Version 3.0 (time frame: within 28 days after the last radiation treatment). 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 30 Jul 2014.