Pancreatic CancerEarly Phase 1NCT01276613
Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas
A Early Phase 1 study testing Gemcitabine and Losartan in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells, to measure the amount of it that may enter the cells, and for biomarker testing. Biomarkers may be related to participant's reaction to the study drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine and Losartan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 19 Apr 2019
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologic or histologic proof of adenocarcinoma of the pancreas is required. Patients with Islet cell tumors are not eligible.
- Patients do not have known metastases.
- Patients must have potentially resectable pancreatic cancer and have agreed to undergo surgical resection at M D Anderson Cancer Center. They will have undergone staging (physical examination, chest x-ray, contrast enhanced CT or MRI (if CT contraindicated) and/or angiogram to determine resectability. Potentially resectable is defined as:No extra-pancreatic disease; No evidence (on CT/MRI) of tumor extension to the celiac axis or SMA; No evidence (CT/MRI or angiogram) of occlusion of the SMV or SMPV confluence.
- Patients with a Karnofsky performance status greater than 70 are eligible.
- There will be no upper age restriction. Patients less than 18 years of age are excluded from the protocol because adenocarcinoma of the pancreas is rarely seen in the pediatric population.
- Adequate renal, and bone marrow function: Leukocytes >= 3,000/uL; Absolute neutrophil count >= 1,500/uL; Platelets >= 100,000/Ul; Serum creatinine <= 2.0 mg/dL.
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- Adequate Hepatic function (endoscopic or percutaneous drainage as needed): Total bilirubin < = 3 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) <= 5 X institutional ULN.
- Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude administration of gemcitabine. Patients with uncontrolled congestive heart failure, unstable angina and myocardial infarction within 3 months will be excluded.
- Patient is not pregnant. Women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent.
- Patients must sign a study-specific consent form.
Who cannot join
- Patient has received preoperative chemotherapy and/or radiation.
- Major cardiovascular or pulmonary comorbidity that precludes use of general anesthesia.
- Identification of metastatic disease.
- Inability to comply with study and/or follow-up procedures.
- Patients < 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells, to measure the amount of it that may enter the cells, and for biomarker testing. Biomarkers may be related to participant's reaction to the study drug.
Read the detailed description
The Study Drugs:
Gemcitabine is a drug used to treat pancreatic cancer. However, there are no studies that show that gemcitabine is able to enter pancreatic cancer cells.
Losartan is a drug that lowers blood pressure. It also may increase the amount of gemcitabine that reaches the cancer cells. Participant may be asked to take this drug before participant's surgery.
Before Surgery:
If participant is found to be eligible and participant agrees to take part in this study, the following tests will be done before participant's surgery:
- Participant will have a routine CT (computed tomography) scan and a research MRI (magnetic resonance imaging) of participant's abdomen to check the status of the disease.
- Blood (about 3-4 teaspoons) will be drawn for biomarker testing.
Participant may be asked to take losartan for 2-4 two to four weeks before participant's surgery (described below).
Surgery:
Participant's surgery will be performed in the same way as it would be even if participant was not taking part in this study. Participant will sign a separate consent form for surgery. The length of the surgery and the time participant is under anesthesia are not changed by taking part in the study.
To measure how much gemcitabine enters pancreas cancer cells, participants who are having their pancreatic cancer removed by surgery will receive an infusion of gemcitabine during the surgery. Some of the pancreatic cancer tissue removed then will be checked to learn if gemcitabine is found in the cancer cells.
During surgery, participant will have routine procedures to learn if the disease has spread to other areas. If the disease has spread beyond the pancreas, surgical removal is not possible.
If for any reason during the surgery, the surgeon decides that removal of the pancreas is not possible, participant will not receive gemcitabine and participation in this study will end.
If there are no signs of spread or other reasons the cancer cannot be removed, the surgeon will begin the process of removal of the disease.
Gemcitabine Infusion:
Participant will receive an infusion of gemcitabine just before the surgeon begins to remove the cancer. Gemcitabine will be given through an infusion catheter that is placed in the operating room after participant is asleep. The infusion will take over 100 minutes. The infusion catheter is not required for the study but is a standard of care procedure for all participants who are having pancreatic cancer surgery. Participant will sign a separate consent form for the infusion catheter.
Losartan Administration:
If participant is asked to take losartan, participant will take 1 tablet by mouth every day for up to 4 weeks before participant's surgery. After Week 1, the study staff will tell participant if participant's dose will stay the same or increase, based on any side effects that participant may have.
Blood and Tissue Collection:
Up to 10 blood samples (about 1 tablespoon each time) will be drawn during surgery starting before the gemcitabine infusion begins and at the end of surgery. The blood samples are used to measure the levels of gemcitabine in participant's blood at different time points. This is called pharmacokinetic (PK) testing. The blood will also be used for biomarker testing. Biomarkers are chemical "markers" in the blood/tissue that may be related to participant's reaction to the study drug.
Some of the tumor tissue and normal tissue removed during surgery will be collected to learn if gemcitabine is able to enter the tissue cells and for biomarker testing.
Length of Study:
Participant's active participation in this study will be over once participant has had surgery and completed the follow-up. The research team will continue to collect information on participant for 30 days after surgery (or until participant is no longer having side effects).
Follow-Up:
The study team will follow participant's health status for 30 days after surgery to check if participant is having any side effects from gemcitabine. This follow-up will be done daily while participant is in the hospital recovering from the surgery. Follow-up will also occur at the time of a routine clinic visit, or by phone call at least once weekly. These calls should last about 5 minutes each.
This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Its use during surgery is investigational.
Losartan is FDA approved and commercially available for the treatment of high blood pressure and diabetic nephropathy. It is not approved for the treatment of pancreatic cancer.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Losartan
- Keywords
- Resectable Adenocarcinoma of the Pancreas, Gemcitabine, Gemcitabine Hydrochloride, Gemzar
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemcitabine Hydrochloride, Gemzar
Gemcitabine administered by the anesthesiologist as a dose of 1,000mg/m2 at a fixed dose rate of 10mg/m2/min.
LosartanDrug
50 mg by mouth daily for one week and 50 to 100 mg of Losartan by mouth daily for at least 1 week and at most 3 weeks prior to surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Gemcitabine | Experimental | Gemcitabine administered by the anesthesiologist as a dose of 1,000mg/m2 at a fixed dose rate of 10mg/m2/min. Drug infusion started 100 minutes prior to complete gross tumor removal in order to have drug administration complete at tumor removal. Receives: Drug: Gemcitabine |
| Intraoperative Gemcitabine + Losartan | Experimental | Losartan 50 mg by mouth daily for one week and 50 to 100 mg of Losartan by mouth daily for at least 1 week and at most 3 weeks prior to surgical resection.
Gemcitabine administered by the anesthesiologist as a dose of 1,000mg/m2 at a fixed dose rate of 10mg/m2/min. Drug infusion started 100 minutes prior to complete gross tumor removal in order to have drug administration complete at tumor removal. Receives: Drug: Gemcitabine; Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue
Pharmacokinetic (PK) Testing of up to 10 blood samples (about 1 tablespoon each time) drawn during surgery starting before gemcitabine infusion and at end of surgery. Blood samples used to measure levels of gemcitabine in blood at the different time points.
Measured: Collection during surgery, participants followed 30 days post surgery
Gemcitabine DNA Levels in Human Pancreatic Cancer Tissue
CT scans analyzed, mapping 3 to 4 areas of pancreatic tumor based on differential enhancement patterns within the tumors, where each selected region is uniform within 5-10 HU at each phase of the CT. Each region will comprise no more than 33% of the greatest size of the tumor. Model parameters for each region plugged into the predictive equations for YVmax, YTmax, R0, and AUC.
Measured: Before surgery, participants followed 30 days post surgery
Secondary outcomes (1)
Effect of Losartan on Gemcitabine DNA Incorporation Human Pancreatic Cancer Tissue
Root mean square error estimated of prediction from the pre-therapy CT scan to be 0.14 pg dFdC/ng dG. From this estimate of the error of prediction, 80% power calculated to detect an absolute increase in gemcitabine delivery of 0.36 pg dFdC/ng dG and a 90% power to detect an absolute increase in gemcitabine delivery of 0.42 pg dFdC/ng dG in a given participant.
Measured: Before surgery, participants followed 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2011
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
Why it stopped: Per memo from study team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kim, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276613
- Sponsor's protocol ID
- 2010-0371
- Other IDs
- NCI-2011-00244, RSD1429), WS#23
- Status last verified
- Apr 2019
- First submitted
- 12 Jan 2011
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Koay EJ, Truty MJ, Cristini V, Thomas RM, Chen R, Chatterjee D, Kang Y, Bhosale PR, Tamm EP, Crane CH, Javle M, Katz MH, Gottumukkala VN, Rozner MA, Shen H, Lee JE, Wang H, Chen Y, Plunkett W, Abbruzzese JL, Wolff RA, Varadhachary GR, Ferrari M, Fleming JB. Transport properties of pancreatic cancer describe gemcitabine delivery and response. J Clin Invest. 2014 Apr;124(4):1525-36. doi: 10.1172/JCI73455. Epub 2014 Mar 10.
PubMed 24614108
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT01276613
- Acronym / sponsor ID
- 2010-0371
- Conditions
- Pancreatic Cancer
- Keywords
- Resectable Adenocarcinoma of the Pancreas, Gemcitabine, Gemcitabine Hydrochloride, Gemzar
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per memo from study team
- Enrolment
- 18 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 13 Jan 2011 (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 goal of this clinical research study is to learn if gemcitabine can enter pancreas cancer cells, to measure the amount of it that may enter the cells, and for biomarker testing. Biomarkers may be related to participant's reaction to the study drug.
Detailed description
The Study Drugs:
Gemcitabine is a drug used to treat pancreatic cancer. However, there are no studies that show that gemcitabine is able to enter pancreatic cancer cells.
Losartan is a drug that lowers blood pressure. It also may increase the amount of gemcitabine that reaches the cancer cells. Participant may be asked to take this drug before participant's surgery.
Before Surgery:
If participant is found to be eligible and participant agrees to take part in this study, the following tests will be done before participant's surgery:
- Participant will have a routine CT (computed tomography) scan and a research MRI (magnetic resonance imaging) of participant's abdomen to check the status of the disease.
- Blood (about 3-4 teaspoons) will be drawn for biomarker testing.
Participant may be asked to take losartan for 2-4 two to four weeks before participant's surgery (described below).
Surgery:
Participant's surgery will be performed in the same way as it would be even if participant was not taking part in this study. Participant will sign a separate consent form for surgery. The length of the surgery and the time participant is under anesthesia are not changed by taking part in the study.
To measure how much gemcitabine enters pancreas cancer cells, participants who are having their pancreatic cancer removed by surgery will receive an infusion of gemcitabine during the surgery. Some of the pancreatic cancer tissue removed then will be checked to learn if gemcitabine is found in the cancer cells.
During surgery, participant will have routine procedures to learn if the disease has spread to other areas. If the disease has spread beyond the pancreas, surgical removal is not possible.
If for any reason during the surgery, the surgeon decides that removal of the pancreas is not possible, participant will not receive gemcitabine and participation in this study will end.
If there are no signs of spread or other reasons the cancer cannot be removed, the surgeon will begin the process of removal of the disease.
Gemcitabine Infusion:
Participant will receive an infusion of gemcitabine just before the surgeon begins to remove the cancer. Gemcitabine will be given through an infusion catheter that is placed in the operating room after participant is asleep. The infusion will take over 100 minutes. The infusion catheter is not required for the study but is a standard of care procedure for all participants who are having pancreatic cancer surgery. Participant will sign a separate consent form for the infusion catheter.
Losartan Administration:
If participant is asked to take losartan, participant will take 1 tablet by mouth every day for up to 4 weeks before participant's surgery. After Week 1, the study staff will tell participant if participant's dose will stay the same or increase, based on any side effects that participant may have.
Blood and Tissue Collection:
Up to 10 blood samples (about 1 tablespoon each time) will be drawn during surgery starting before the gemcitabine infusion begins and at the end of surgery. The blood samples are used to measure the levels of gemcitabine in participant's blood at different time points. This is called pharmacokinetic (PK) testing. The blood will also be used for biomarker testing. Biomarkers are chemical "markers" in the blood/tissue that may be related to participant's reaction to the study drug.
Some of the tumor tissue and normal tissue removed during surgery will be collected to learn if gemcitabine is able to enter the tissue cells and for biomarker testing.
Length of Study:
Participant's active participation in this study will be over once participant has had surgery and completed the follow-up. The research team will continue to collect information on participant for 30 days after surgery (or until participant is no longer having side effects).
Follow-Up:
The study team will follow participant's health status for 30 days after surgery to check if participant is having any side effects from gemcitabine. This follow-up will be done daily while participant is in the hospital recovering from the surgery. Follow-up will also occur at the time of a routine clinic visit, or by phone call at least once weekly. These calls should last about 5 minutes each.
This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Its use during surgery is investigational.
Losartan is FDA approved and commercially available for the treatment of high blood pressure and diabetic nephropathy. It is not approved for the treatment of pancreatic cancer.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Gemcitabine | Experimental | Drug: GemcitabineGemcitabine administered by the anesthesiologist as a dose of 1,000mg/m2 at a fixed dose rate of 10mg/m2/min. Drug infusion started 100 minutes prior to complete gross tumor removal in order to have drug administration complete at tumor removal. |
| Intraoperative Gemcitabine + Losartan | Experimental | Drug: Gemcitabine, Drug: LosartanLosartan 50 mg by mouth daily for one week and 50 to 100 mg of Losartan by mouth daily for at least 1 week and at most 3 weeks prior to surgical resection. Gemcitabine administered by the anesthesiologist as a dose of 1,000mg/m2 at a fixed dose rate of 10mg/m2/min. Drug infusion started 100 minutes prior to complete gross tumor removal in order to have drug administration complete at tumor removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Cytologic or histologic proof of adenocarcinoma of the pancreas is required. Patients with Islet cell tumors are not eligible.
- Patients do not have known metastases.
- Patients must have potentially resectable pancreatic cancer and have agreed to undergo surgical resection at M D Anderson Cancer Center. They will have undergone staging (physical examination, chest x-ray, contrast enhanced CT or MRI (if CT contraindicated) and/or angiogram to determine resectability. Potentially resectable is defined as:No extra-pancreatic disease; No evidence (on CT/MRI) of tumor extension to the celiac axis or SMA; No evidence (CT/MRI or angiogram) of occlusion of the SMV or SMPV confluence.
- Patients with a Karnofsky performance status greater than 70 are eligible.
- There will be no upper age restriction. Patients less than 18 years of age are excluded from the protocol because adenocarcinoma of the pancreas is rarely seen in the pediatric population.
Key exclusion criteria (5 listed)
- Patient has received preoperative chemotherapy and/or radiation.
- Major cardiovascular or pulmonary comorbidity that precludes use of general anesthesia.
- Identification of metastatic disease.
- Inability to comply with study and/or follow-up procedures.
- Patients < 18 years of age.
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 |
|---|---|---|
| GemcitabineAlso: Gemcitabine Hydrochloride, GemzarGemcitabine administered by the anesthesiologist as a dose of 1,000mg/m2 at a fixed dose rate of 10mg/m2/min. | Drug | Intraoperative Gemcitabine, Intraoperative Gemcitabine + Losartan |
| Losartan50 mg by mouth daily for one week and 50 to 100 mg of Losartan by mouth daily for at least 1 week and at most 3 weeks prior to surgical resection. | Drug | Intraoperative Gemcitabine + Losartan |
Primary outcome
Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue
Time frame: Collection during surgery, participants followed 30 days post surgery
Pharmacokinetic (PK) Testing of up to 10 blood samples (about 1 tablespoon each time) drawn during surgery starting before gemcitabine infusion and at end of surgery. Blood samples used to measure levels of gemcitabine in blood at the different time points.
Gemcitabine DNA Levels in Human Pancreatic Cancer Tissue
Time frame: Before surgery, participants followed 30 days post surgery
CT scans analyzed, mapping 3 to 4 areas of pancreatic tumor based on differential enhancement patterns within the tumors, where each selected region is uniform within 5-10 HU at each phase of the CT. Each region will comprise no more than 33% of the greatest size of the tumor. Model parameters for each region plugged into the predictive equations for YVmax, YTmax, R0, and AUC.
1 secondary outcome
Effect of Losartan on Gemcitabine DNA Incorporation Human Pancreatic Cancer Tissue
Time frame: Before surgery, participants followed 30 days post surgery
Results and safety
The study was stopped early (reason given: Per memo from study team). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Derived from this study: PubMed 24614108Koay EJ, Truty MJ, Cristini V, Thomas RM, Chen R, Chatterjee D, Kang Y, Bhosale PR, Tamm EP, Crane CH, Javle M, Katz MH, Gottumukkala VN, Rozner MA, Shen H, Lee JE, Wang H, Chen Y, Plunkett W, Abbruzzese JL, Wolff RA, Varadhachary GR, Ferrari M, Fleming JB. Transport properties of pancreatic cancer describe gemcitabine delivery and response. J Clin Invest. 2014 Apr;124(4):1525-36. doi: 10.1172/JCI73455. Epub 2014 Mar 10.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kim, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gemcitabine and Losartan in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center 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 10 inclusion and 5 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 2 May 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Per memo from study team). Results are not available in the source record.
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?
Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue (time frame: Collection during surgery, participants followed 30 days post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01276613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.