Prostate CancerNCT02123862
Cultured Circulating Tumor Cells in Prostate and Other Cancers
An observational study of Prostate Cancer, run by Oscar Goodman, Jr. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the number of circulating tumor cells (CTC) before and after treatment using an experimental method for detecting CTC, compared to commercial CTC assay results, in patients with prostate, breast or colorectal cancers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2018
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be having blood drawn at Comprehensive Cancer Centers of Nevada as part of their routine care.
Who may be able to join
- Diagnosis of prostate cancer, breast cancer, or other cancer, OR have no cancer. All participants will be having blood drawn at Comprehensive Cancer Centers of Nevada as part of their routine care.
- 18 years of age or older.
- All participants must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and FDA guidelines.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Oscar B Goodman, Jr., MD, PhD, 702-952-1251, oscar.goodman@usoncology.com
Joyson D Pekkattil, 702-952-3714, joyson.pekkattil@usoncology.com
About this study
Official title: Cultured Circulating Tumor Cells - Development of a Novel Platform for Drug Discovery and in Vitro Chemosensitivity Testing in Prostate and Other Cancers
The purpose of this study is to evaluate the number of circulating tumor cells (CTC) before and after treatment using an experimental method for detecting CTC, compared to commercial CTC assay results, in patients with prostate, breast or colorectal cancers.
Experiments will be done to develop a new assay technique and also test how CTC react to commonly used drugs. This information will be analyzed to determine if the experimental assays can be helpful in the future to predict how a patient's cancer may react to certain treatments.
Read more
The research experiments will also attempt to grow CTC for long-term or "immortal" cell lines that can be further studied for proteins and gene mutations related to the specific tumor (not familial), and testing for sensitivity to drugs.
Blood samples will be collected at specific time points during routine medical care from patients with prostate, breast, colorectal or other solid tumor cancer. Samples will also be collected from patients with no cancer for comparison purposes. Samples for the experimental tests will be identified only by codes and results will not be shared with participants. Patients with prostate, breast or colorectal cancer will also have blood samples drawn for commercial CTC assays as part of their standard care.
Read the detailed description
Prostate cancer is the most common cancer in men, with the exception of non-melanomatous skin cancer, and the second leading cause of cancer death among men. According to the Center for Disease Control and United States Cancer Statistics (USCS), in the year 2007 there were 29,093 deaths caused by prostate cancer, and 223,307 men were newly diagnosed with the disease in the United States Given the clinical heterogeneity of this disease as well as the toxicities of current therapies, new prognostic and predictive biomarkers are much needed to facilitate informed therapeutic decision making.
A strong correlation between the CTC and the progression of breast, colon and prostate cancers has been demonstrated, being both prognostic and predictive of response to therapy and overall survival. The use of the Veridex CellSearch™ CTC assay has been approved by the FDA to monitor breast and colon cancer therapy. CTCs are a standard of care for monitoring response to prostate cancer treatment, as well. It is likely that changes in the number of CTCs may also be a predictive indicator of treatment response.
Techniques utilized in the Veridex Cellsearch™ severely damage CTC in the process, removing the possibility for further study and characterization of the CTC. This study will attempt to improve upon the technology by developing and testing a novel strategy for isolation of intact and viable CTCs, and compare the results to the CellSearch™ benchmark. CTC Development of short or long-term cell lines from these samples would greatly facilitate further characterization of metastasis-producing cells from individual patients. For example, this may allow identification of somatic gene mutations (e.g. in AR) that predict drug therapy responses, global gene and protein expression patterns, drug sensitivity and resistance testing.
Following informed consent, all patients will have two 7.5 cc samples of blood drawn at a time when routine blood work related to disease monitoring or treatment is drawn. In addition, those patients with a diagnosis of breast cancer, prostate cancer, or colorectal cancer will have an additional 10cc drawn into a CellSave tube for standard of care CellSearch™ CTC enumeration if their insurance covers the cost. Additional samples will be obtained from selected patients during or following treatment to monitor disease progression or treatment response.
Samples will be de-identified and sent to Dr. Goodman's laboratory at Roseman University of Health Sciences. Samples will be processed and results entered into a password-protected database. Results of experiments on the research samples will not be shared with the patient. Results from the CellSearch™ CTC assay will be de-identified by an honest broker and entered into the database. Patient information will also be collected, de-identified and entered into the database. Information will include age, gender, tumor status (TNM), serum LDH, other pertinent standard of care tumor markers (PSA, CEA, or CA 27-29, if available), date of tumor diagnosis, treatment history, date of regional and metastatic progression and date of death (if applicable).
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Breast Cancer, Colorectal Cancer, Colon Cancer, Rectal Cancer, Cancer, Solid Tumor, Metastatic, Circulating Tumor Cells
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Neoplasms, Neoplasm Metastasis, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Not described | |
| Breast Cancer | Not described | |
| Colorectal Cancer | Not described | |
| Solid Tumor | Not described | |
| Benign Condition | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate novel CTC assay method as a predictive tool for prostate, breast and colorectal cancers.
Colony counts will be assessed using a novel 3-D assay and a commercial CTC count method (CellSearch™). Samples will be collected prior to and post initiation of treatment. Results will be evaluated for changes in CTC counts.
Measured: Completed within 12 months after last sample collected.
Secondary outcomes (4)
Sensitivity and specificity comparison
Results of the novel 3-D assay technique will be compared with results of the commercial CellSearch™ assay for patients with breast, prostate or colon cancer. Results will be evaluated for sensitivity and specificity for the particular cancer.
Measured: Baseline, post treatment (up to 12 months)
Develop in vitro assay for chemotherapy sensitivity testing
CTC will be tested for sensitivity to select drug and biologic agents with the aim to develop a useful sensitivity assay.
Measured: Baseline, post treatment (up to 12 months)
IC50 correlation with CTC response and clinical outcome
IC50 will be determined for each patient. Exploratory analyses will be performed to determine if in vitro efficacy correlates with observed CTC counts and clinical outcome.
Measured: Baseline, post treatment (up to 12 months)
Attempt growth of long-term tumor cell lines for evaluation
In samples that experience extensive CTC growth, attempts will be made to culture cell lines over the long term in flasks using culture medium and standard tissue culture approaches.
Measured: Baseline, post treatment (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oscar Goodman, Jr.
- Sponsor type
- University, hospital or other
- Collaborators
- Comprehensive Cancer Centers of Nevada, Roseman University of Health Sciences
- Responsible party
- Sponsor-investigator, Oscar Goodman, Jr., Comprehensive Cancer Centers of Nevada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123862
- Sponsor's protocol ID
- 11.08.002
- Status last verified
- Jan 2015
- First submitted
- 3 Feb 2014
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Halabi S, Small EJ, Kantoff PW, Kattan MW, Kaplan EB, Dawson NA, Levine EG, Blumenstein BA, Vogelzang NJ. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol. 2003 Apr 1;21(7):1232-7. doi: 10.1200/JCO.2003.06.100.
PubMed 12663709Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.
PubMed 15470213Collette L, Burzykowski T, Carroll KJ, Newling D, Morris T, Schroder FH; European Organisation for Research and Treatment of Cancer; Limburgs Universitair Centrum; AstraZeneca Pharmaceuticals. Is prostate-specific antigen a valid surrogate end point for survival in hormonally treated patients with metastatic prostate cancer? Joint research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum, and AstraZeneca Pharmaceuticals. J Clin Oncol. 2005 Sep 1;23(25):6139-48. doi: 10.1200/JCO.2005.08.156.
PubMed 16135480Budd GT, Cristofanilli M, Ellis MJ, Stopeck A, Borden E, Miller MC, Matera J, Repollet M, Doyle GV, Terstappen LW, Hayes DF. Circulating tumor cells versus imaging--predicting overall survival in metastatic breast cancer. Clin Cancer Res. 2006 Nov 1;12(21):6403-9. doi: 10.1158/1078-0432.CCR-05-1769.
PubMed 17085652Smerage JB, Hayes DF. The measurement and therapeutic implications of circulating tumour cells in breast cancer. Br J Cancer. 2006 Jan 16;94(1):8-12. doi: 10.1038/sj.bjc.6602871.
PubMed 16317435Allard WJ, Matera J, Miller MC, Repollet M, Connelly MC, Rao C, Tibbe AG, Uhr JW, Terstappen LW. Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res. 2004 Oct 15;10(20):6897-904. doi: 10.1158/1078-0432.CCR-04-0378.
PubMed 15501967Cohen SJ, Punt CJ, Iannotti N, Saidman BH, Sabbath KD, Gabrail NY, Picus J, Morse MA, Mitchell E, Miller MC, Doyle GV, Tissing H, Terstappen LW, Meropol NJ. Prognostic significance of circulating tumor cells in patients with metastatic colorectal cancer. Ann Oncol. 2009 Jul;20(7):1223-9. doi: 10.1093/annonc/mdn786. Epub 2009 Mar 12.
PubMed 19282466de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, Doyle GV, Terstappen LW, Pienta KJ, Raghavan D. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res. 2008 Oct 1;14(19):6302-9. doi: 10.1158/1078-0432.CCR-08-0872.
PubMed 18829513Danila DC, Heller G, Gignac GA, Gonzalez-Espinoza R, Anand A, Tanaka E, Lilja H, Schwartz L, Larson S, Fleisher M, Scher HI. Circulating tumor cell number and prognosis in progressive castration-resistant prostate cancer. Clin Cancer Res. 2007 Dec 1;13(23):7053-8. doi: 10.1158/1078-0432.CCR-07-1506.
PubMed 18056182
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultured Circulating Tumor Cells - Development of a Novel Platform for Drug Discovery and in Vitro Chemosensitivity Testing in Prostate and Other Cancers
- ClinicalTrials.gov ID
- NCT02123862
- Acronym / sponsor ID
- 11.08.002
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Breast Cancer, Colorectal Cancer, Colon Cancer, Rectal Cancer, Cancer, Solid Tumor, Metastatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Oscar Goodman, Jr.University, hospital or other
- Collaborators
- Comprehensive Cancer Centers of Nevada, Roseman University of Health Sciences
- Study start
- Apr 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 28 Apr 2014 (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.
The purpose of this study is to evaluate the number of circulating tumor cells (CTC) before and after treatment using an experimental method for detecting CTC, compared to commercial CTC assay results, in patients with prostate, breast or colorectal cancers.
Experiments will be done to develop a new assay technique and also test how CTC react to commonly used drugs. This information will be analyzed to determine if the experimental assays can be helpful in the future to predict how a patient's cancer may react to certain treatments.
The research experiments will also attempt to grow CTC for long-term or "immortal" cell lines that can be further studied for proteins and gene mutations related to the specific tumor (not familial), and testing for sensitivity to drugs.
Blood samples will be collected at specific time points during routine medical care from patients with prostate, breast, colorectal or other solid tumor cancer. Samples will also be collected from patients with no cancer for comparison purposes. Samples for the experimental tests will be identified only by codes and results will not be shared with participants. Patients with prostate, breast or colorectal cancer will also have blood samples drawn for commercial CTC assays as part of their standard care.
Detailed description
Prostate cancer is the most common cancer in men, with the exception of non-melanomatous skin cancer, and the second leading cause of cancer death among men. According to the Center for Disease Control and United States Cancer Statistics (USCS), in the year 2007 there were 29,093 deaths caused by prostate cancer, and 223,307 men were newly diagnosed with the disease in the United States Given the clinical heterogeneity of this disease as well as the toxicities of current therapies, new prognostic and predictive biomarkers are much needed to facilitate informed therapeutic decision making.
A strong correlation between the CTC and the progression of breast, colon and prostate cancers has been demonstrated, being both prognostic and predictive of response to therapy and overall survival. The use of the Veridex CellSearch™ CTC assay has been approved by the FDA to monitor breast and colon cancer therapy. CTCs are a standard of care for monitoring response to prostate cancer treatment, as well. It is likely that changes in the number of CTCs may also be a predictive indicator of treatment response.
Techniques utilized in the Veridex Cellsearch™ severely damage CTC in the process, removing the possibility for further study and characterization of the CTC. This study will attempt to improve upon the technology by developing and testing a novel strategy for isolation of intact and viable CTCs, and compare the results to the CellSearch™ benchmark. CTC Development of short or long-term cell lines from these samples would greatly facilitate further characterization of metastasis-producing cells from individual patients. For example, this may allow identification of somatic gene mutations (e.g. in AR) that predict drug therapy responses, global gene and protein expression patterns, drug sensitivity and resistance testing.
Following informed consent, all patients will have two 7.5 cc samples of blood drawn at a time when routine blood work related to disease monitoring or treatment is drawn. In addition, those patients with a diagnosis of breast cancer, prostate cancer, or colorectal cancer will have an additional 10cc drawn into a CellSave tube for standard of care CellSearch™ CTC enumeration if their insurance covers the cost. Additional samples will be obtained from selected patients during or following treatment to monitor disease progression or treatment response.
Samples will be de-identified and sent to Dr. Goodman's laboratory at Roseman University of Health Sciences. Samples will be processed and results entered into a password-protected database. Results of experiments on the research samples will not be shared with the patient. Results from the CellSearch™ CTC assay will be de-identified by an honest broker and entered into the database. Patient information will also be collected, de-identified and entered into the database. Information will include age, gender, tumor status (TNM), serum LDH, other pertinent standard of care tumor markers (PSA, CEA, or CA 27-29, if available), date of tumor diagnosis, treatment history, date of regional and metastatic progression and date of death (if applicable).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | – | – |
| Breast Cancer | – | – |
| Colorectal Cancer | – | – |
| Solid Tumor | – | – |
| Benign Condition | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be having blood drawn at Comprehensive Cancer Centers of Nevada as part of their routine care.
Key inclusion criteria (3 listed)
- Diagnosis of prostate cancer, breast cancer, or other cancer, OR have no cancer. All participants will be having blood drawn at Comprehensive Cancer Centers of Nevada as part of their routine care.
- 18 years of age or older.
- All participants must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and FDA guidelines.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate novel CTC assay method as a predictive tool for prostate, breast and colorectal cancers.
Time frame: Completed within 12 months after last sample collected.
Colony counts will be assessed using a novel 3-D assay and a commercial CTC count method (CellSearch™). Samples will be collected prior to and post initiation of treatment. Results will be evaluated for changes in CTC counts.
4 secondary outcomes
Sensitivity and specificity comparison
Time frame: Baseline, post treatment (up to 12 months)
Develop in vitro assay for chemotherapy sensitivity testing
Time frame: Baseline, post treatment (up to 12 months)
IC50 correlation with CTC response and clinical outcome
Time frame: Baseline, post treatment (up to 12 months)
Attempt growth of long-term tumor cell lines for evaluation
Time frame: Baseline, post treatment (up to 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Background: PubMed 12663709Halabi S, Small EJ, Kantoff PW, Kattan MW, Kaplan EB, Dawson NA, Levine EG, Blumenstein BA, Vogelzang NJ. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol. 2003 Apr 1;21(7):1232-7. doi: 10.1200/JCO.2003.06.100.
- Background: PubMed 15470213Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.
- Background: PubMed 16135480Collette L, Burzykowski T, Carroll KJ, Newling D, Morris T, Schroder FH; European Organisation for Research and Treatment of Cancer; Limburgs Universitair Centrum; AstraZeneca Pharmaceuticals. Is prostate-specific antigen a valid surrogate end point for survival in hormonally treated patients with metastatic prostate cancer? Joint research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum, and AstraZeneca Pharmaceuticals. J Clin Oncol. 2005 Sep 1;23(25):6139-48. doi: 10.1200/JCO.2005.08.156.
- Background: PubMed 17085652Budd GT, Cristofanilli M, Ellis MJ, Stopeck A, Borden E, Miller MC, Matera J, Repollet M, Doyle GV, Terstappen LW, Hayes DF. Circulating tumor cells versus imaging--predicting overall survival in metastatic breast cancer. Clin Cancer Res. 2006 Nov 1;12(21):6403-9. doi: 10.1158/1078-0432.CCR-05-1769.
- Background: PubMed 16317435Smerage JB, Hayes DF. The measurement and therapeutic implications of circulating tumour cells in breast cancer. Br J Cancer. 2006 Jan 16;94(1):8-12. doi: 10.1038/sj.bjc.6602871.
- Background: PubMed 15501967Allard WJ, Matera J, Miller MC, Repollet M, Connelly MC, Rao C, Tibbe AG, Uhr JW, Terstappen LW. Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res. 2004 Oct 15;10(20):6897-904. doi: 10.1158/1078-0432.CCR-04-0378.
- Background: PubMed 19282466Cohen SJ, Punt CJ, Iannotti N, Saidman BH, Sabbath KD, Gabrail NY, Picus J, Morse MA, Mitchell E, Miller MC, Doyle GV, Tissing H, Terstappen LW, Meropol NJ. Prognostic significance of circulating tumor cells in patients with metastatic colorectal cancer. Ann Oncol. 2009 Jul;20(7):1223-9. doi: 10.1093/annonc/mdn786. Epub 2009 Mar 12.
- Background: PubMed 18829513de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, Doyle GV, Terstappen LW, Pienta KJ, Raghavan D. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res. 2008 Oct 1;14(19):6302-9. doi: 10.1158/1078-0432.CCR-08-0872.
- Background: PubMed 18056182Danila DC, Heller G, Gignac GA, Gonzalez-Espinoza R, Anand A, Tanaka E, Lilja H, Schwartz L, Larson S, Fleisher M, Scher HI. Circulating tumor cell number and prognosis in progressive castration-resistant prostate cancer. Clin Cancer Res. 2007 Dec 1;13(23):7053-8. doi: 10.1158/1078-0432.CCR-07-1506.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Oscar Goodman, Jr. 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jan 2015. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oscar B Goodman, Jr., MD, PhD (702-952-1251, oscar.goodman@usoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate novel CTC assay method as a predictive tool for prostate, breast and colorectal cancers. (time frame: Completed within 12 months after last sample collected.). 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 NCT02123862, which also lists 9 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 19 Jan 2015.