Biliary Tract CancerPhase 2/3NCT03873532
A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients
A Phase 2/3 study testing Surufatinib and Capecitabine in people with Biliary Tract Cancer, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study to evaluate the efficacy and safety of surufatinib vs. Capecitabine as a second-line therapy in patients with unresectable or metastatic biliary tract cancer (BTC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Surufatinib and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2018to Mar 2022
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are fully informed about the study and voluntarily sign the informed consent (prior to the implementation of any specific procedure for the trial);
- 18-75 years old (inclusive);
- Patients with histologically or cytologically confirmed unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC) and gallbladder cancer (GBC);
- Patients have failed first-line standard systemic chemotherapy. A first-line standard systemic chemotherapy is defined as a regimen of gemcitabine combined with platinum-based therapy. The failure of a first-line standard chemotherapy is defined by progressive disease during the treatment or within 6 months after the last treatment, or intolerable toxicity during the treatment.
- Note: a. The time of first-line medication is ≥ 1 cycle of combination chemotherapy; b. Neoadjuvant or adjuvant chemotherapy is allowed in the early stage, and should be considered failed as a first-line systemic chemotherapy for progressive disease if progressive disease/recurrence occurs during the course of the neoadjuvant/adjuvant therapy or within 6 months after the end of treatment; c. The previous first-line standard chemotherapy does not contain any small molecular anti-angiogenesis agents or monoclonal antibodies, or any drugs related to tumor immunity;
- ECOG performance status of 0 or 1 (Annex 1);
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- Liver function with a modified Child-Pugh score of < 7;
- Confirmed measurable (or evaluable) lesions that meet the requirements of RECIST 1.1;
- Expected survival of ≥ 12 weeks;
- Fertile male or female patients shall volunteer to use effective contraceptive methods, such as double barrier contraception, condoms, oral or injected contraceptives, and intrauterine devices, during the study period and within 90 days after the last dosing of the investigational drug. All female patients will be considered fertile unless they have had natural menopause, or artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or ovarian radiation).
Who cannot join
- Received a systemic anti-cancer therapy that has been approved or in development, including chemotherapy, radical radiotherapy, bio-immunotherapy, targeted therapy, and treatment by traditional Chinese medicines (if the instructions of the traditional Chinese medicines specifies clear indications for anti-tumor therapy, the patient may be enrolled after an 1 week of washout period), within 4 weeks prior to randomization;
- Received a systemic chemotherapy (a neoadjuvant or adjuvant chemotherapy except those that have not failed within 6 months) other than gemcitabine combined with platinum-based therapy (such as fluorouracil-based chemotherapy) prior to randomization; or received an anti-tumor immunotherapy, such as PD-1 and PD-L1 therapies;
- Received any surgery or invasive treatment/operation (except venous catheterization, puncture and drainage, etc) within 4 weeks prior to randomization;
- Received any major surgical operations within 60 days before randomization, or have any incisions that have not completely healed;
- Received a local anti-tumor therapy such as hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation within 4 weeks prior to randomization;
- Patients with any of the following laboratory abnormalities:
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- Absolute neutrophil count (ANC) < 1.5 × 109/L, or platelet (PLT) < 100 × 109/L, or hemoglobin (Hb) < 90 g/L;
- Total bilirubin ≥ 1.5 × Upper Limit of Normal (ULN);
- In the absence of liver metastasis, alanine transaminase (ALT) and/or aspartate transaminase (AST) ≥ 1.5 × ULN; in the presence of liver metastasis, ALT and/or AST ≥ 3 × ULN;
- Serum creatinine ≥ 1.5 × ULN or creatinine clearance < 50 mL/min (calculated according to the Cockcroft-Gault formula, as shown in Annex 2);
- Routine urinalysis shows urinary protein of ≥ 2+ or 24-hours urinary protein of ≥ 1 g;
- Uncontrolled malignant ascites (ascites that cannot be controlled by diuretics or puncture as judged by the investigator);
- Liver metastases accounting for half or more of the total liver volume as determined by the investigator;
- International normalized ratio (INR) > 1.5 or activated partial thromboplastin time (APTT) > 1.5 × ULN;
- Clinically significant electrolyte abnormalities as determined by the investigator;
- Patients with hypertension that is uncontrollable by medications, defined as: systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg;
- Patients with poorly controlled diabetes mellitus (fasting blood glucose ≥ CTCAE grade 2 after regular treatment);
- Patients with any disease or condition affecting drug absorption, or patients cannot be treated via oral drug administration;
- Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases, active bleeding caused by unresected tumors, or other conditions that may lead to gastrointestinal bleeding or perforation as judged by the investigator;
- With evidence or history of apparent bleeding tendency within 3 months prior to randomization (bleeding volume > 30 mL over 3 months, with hematemesis, melena, or hematochezia), hemoptysis (> 5 mL of fresh blood over 4 weeks), or history of thromboembolism within the past 12 months (including stroke and/or transient ischemic attack);
- With clinically significant cardiovascular diseases, including but not limited to: acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months prior to randomization; congestive heart failure of New York Heart Association (NYHA) grade > 2; ventricular arrhythmias requiring medication; and left ventricular ejection fraction (LVEF) < 50%;
- Other malignant tumors in the past 5 five years, except basal cell or squamous cell carcinoma that has been treated by radical operation or carcinoma in situ of the cervix;
- Active or uncontrolled severe infection (≥ CTCAE grade 2) within 2 weeks prior to randomization;
- Known infection of human immunodeficiency virus (HIV);
- Known history of clinically significant liver diseases, including viral hepatitis [for known carriers of hepatitis B virus (HBV), the presence of active HBV infection, i.e., positive HBV DNA (> 1 × 104 copies/mL or > 2000 IU/mL), must be excluded; known infection of hepatitis C virus (HCV) with positive HCV RNA (> 1 × 103 copies/mL)], or other hepatitis or cirrhosis;
- Patients with metastasis in the central nervous system (CNS) or previous brain metastasis;
- Any unresolved toxicity (> CTCAE grade 1) from previous anti-cancer therapy, excluding alopecia or neurotoxicity of ≤ grade 2 caused by oxaliplatin;
- Patients participated in clinical trials of other investigational drugs which have not been approved or marketed in China and received corresponding treatment within 4 weeks prior to randomization;
- Pregnant (positive pregnancy test before dosing) or breast-feeding women;
- Received transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony stimulating factor (G-CSF) within 14 days prior to randomization;
- Received brachytherapy (implantation of radioactive particles) within 60 days before the first dose;
- Any other diseases with clinically significant metabolic abnormalities, abnormal physical observations or abnormal laboratory findings, which are judged by the investigator as evidence that the patient has a disease or condition that is unsuitable for the study drug (e.g., epileptic seizures requiring treatment), or that would interfere with the interpretation of the study results, or that may put the patient at a high risk.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PLA 307 Hospital
Beijing, Beijing Municipality, 100000
Jianming Xu, MD
Jianming Xu, MD
About this study
Official title: A Randomized, Open, Multi-center Phase IIb/III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Capecitabine in Advanced or Metastatic Biliary Tract Carcinoma (BTC) Patients
This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study to evaluate the efficacy and safety of surufatinib vs. Capecitabine as a second-line therapy in patients with unresectable or metastatic biliary tract cancer (BTC). About 298 subjects are randomly assigned to two study treatment groups in the ratio of 1:1 by Interactive Web Response System (IWRS).
- Active group: 300 mg of surufatinib，once a day for 3 weeks as a cycle;
- Control group: In each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral administration twice a day for 2 weeks, followed by 1 week rest period (equivalent to 2500 mg/m2 total daily dose).
All patients will be treated based on the arm to which they have been randomized. Treatment on study will continue until disease progression, death, intolerable toxicity or other criteria for discontinuation from study treatment. The tumor assessments are performed with imaging every 6 weeks (+3 days) until progressive disease (RECIST v1.1) or death on the study treatment period, and the treatment and survival of the patients after progressive disease are recorded. Safety indicators include adverse events, laboratory tests, vital signs, and changes in electrocardiograms and echocardiograms.
Read the detailed description
This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study to evaluate the efficacy and safety of surufatinib vs. Capecitabine as a second-line therapy in patients with unresectable or metastatic biliary tract cancer (BTC). About 298 subjects are randomly assigned to two study treatment groups in the ratio of 1:1 by IWRS.
- Active group: 300 mg of surufatinib is given by oral administration once a day (QD) every 3 weeks;
- Control group: In each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral administration twice a day (BID) for 2 weeks, followed by 1 week rest period (equivalent to 2500 mg/m2 total daily dose).
Patients are randomized with the following stratification factors:
- Eastern Cooperative Oncology Group (ECOG) Performance Status (0 or 1);
- Years from the first diagnosis of BTC to the randomization date (≤ 1 year or > 1 year);
- The primary site of the tumor (intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma or gallbladder cancer).
All patients will be treated based on the arm to which they have been randomized. Treatment on study will continue until disease progression, death, intolerable toxicity or other criteria for discontinuation from study treatment. The tumor assessments are performed with imaging every 6 weeks (+3 days) until progressive disease (RECIST v1.1) or death on the study treatment period, and the treatment and survival of the patients after progressive disease are recorded. Safety indicators include adverse events, laboratory tests, vital signs, and changes in electrocardiograms and echocardiograms.
- Conditions
- Biliary Tract Cancer
- Being tested
- Surufatinib, Capecitabine
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Also called HMPL-012 and Sulfatinib
Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 21-day treatment cycle).
CapecitabineDrug
Also called Xeloda
Capecitabine is given at 1250 mg/m2 by oral administration twice a day (BID, one dose each in the morning and evening, with a total dose of 2500 mg/m2 per day) for 2 weeks followed by 1 week of drug interruption. Each course of treatment will last 3 weeks. Capecitabine tablets should be swallowed with water within 30 minutes after a meal.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | 300 mg of surufatinib is given by oral administration once a day (QD) every 3 weeks; Receives: Drug: Surufatinib |
| Control group | Active comparator | In each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral administration twice a day (BID) for 2 weeks, followed by 1 week rest period (equivalent to 2500 mg/m2 total daily dose). Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Compare the Overall survival (OS) rate between surufatinib group and Capecitabine group.
Measured: 5 months after the last patient enrolled.
Secondary outcomes (4)
Progression-free survival (PFS)
Compare the Progression-free survival (PFS) rate between surufatinib group and Capecitabine group.
Measured: 5 months after the last patient enrolled.
Objective remission rate (ORR)
Compare the Objective remission rate (ORR) rate between surufatinib group and Capecitabine group.
Measured: 5 months after the last patient enrolled.
Disease control rate (DCR)
Compare the Disease control rate (DCR) rate between surufatinib group and Capecitabine group.
Measured: 5 months after the last patient enrolled.
Duration of response (DOR)
Compare the Duration of response (DOR) rate between surufatinib group and Capecitabine group.
Measured: 5 months after the last patient enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start10 Jul 2018
- Primary completionJun 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rongjun Liu, Study director, Hutchison Medipharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873532
- Sponsor's protocol ID
- 2017-012-00CH2
- Status last verified
- Feb 2020
- First submitted
- 12 Mar 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Multi-center Phase IIb/III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Capecitabine in Advanced or Metastatic Biliary Tract Carcinoma (BTC) Patients
- ClinicalTrials.gov ID
- NCT03873532
- Acronym / sponsor ID
- 2017-012-00CH2
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 13 Mar 2019 (actual)
- 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 randomized, open-label, active-control, multi-center, phase IIb/III clinical study to evaluate the efficacy and safety of surufatinib vs. Capecitabine as a second-line therapy in patients with unresectable or metastatic biliary tract cancer (BTC). About 298 subjects are randomly assigned to two study treatment groups in the ratio of 1:1 by Interactive Web Response System (IWRS).
- Active group: 300 mg of surufatinib，once a day for 3 weeks as a cycle;
- Control group: In each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral administration twice a day for 2 weeks, followed by 1 week rest period (equivalent to 2500 mg/m2 total daily dose).
All patients will be treated based on the arm to which they have been randomized. Treatment on study will continue until disease progression, death, intolerable toxicity or other criteria for discontinuation from study treatment. The tumor assessments are performed with imaging every 6 weeks (+3 days) until progressive disease (RECIST v1.1) or death on the study treatment period, and the treatment and survival of the patients after progressive disease are recorded. Safety indicators include adverse events, laboratory tests, vital signs, and changes in electrocardiograms and echocardiograms.
Detailed description
This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study to evaluate the efficacy and safety of surufatinib vs. Capecitabine as a second-line therapy in patients with unresectable or metastatic biliary tract cancer (BTC). About 298 subjects are randomly assigned to two study treatment groups in the ratio of 1:1 by IWRS.
- Active group: 300 mg of surufatinib is given by oral administration once a day (QD) every 3 weeks;
- Control group: In each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral administration twice a day (BID) for 2 weeks, followed by 1 week rest period (equivalent to 2500 mg/m2 total daily dose).
Patients are randomized with the following stratification factors:
- Eastern Cooperative Oncology Group (ECOG) Performance Status (0 or 1);
- Years from the first diagnosis of BTC to the randomization date (≤ 1 year or > 1 year);
- The primary site of the tumor (intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma or gallbladder cancer).
All patients will be treated based on the arm to which they have been randomized. Treatment on study will continue until disease progression, death, intolerable toxicity or other criteria for discontinuation from study treatment. The tumor assessments are performed with imaging every 6 weeks (+3 days) until progressive disease (RECIST v1.1) or death on the study treatment period, and the treatment and survival of the patients after progressive disease are recorded. Safety indicators include adverse events, laboratory tests, vital signs, and changes in electrocardiograms and echocardiograms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Drug: Surufatinib300 mg of surufatinib is given by oral administration once a day (QD) every 3 weeks; |
| Control group | Active comparator | Drug: CapecitabineIn each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral administration twice a day (BID) for 2 weeks, followed by 1 week rest period (equivalent to 2500 mg/m2 total daily dose). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients are fully informed about the study and voluntarily sign the informed consent (prior to the implementation of any specific procedure for the trial);
- 18-75 years old (inclusive);
- Patients with histologically or cytologically confirmed unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC) and gallbladder cancer (GBC);
- Patients have failed first-line standard systemic chemotherapy. A first-line standard systemic chemotherapy is defined as a regimen of gemcitabine combined with platinum-based therapy. The failure of a first-line standard chemotherapy is defined by progressive disease during the treatment or within 6 months after the last treatment, or intolerable toxicity during the treatment.
- Note: a. The time of first-line medication is ≥ 1 cycle of combination chemotherapy; b. Neoadjuvant or adjuvant chemotherapy is allowed in the early stage, and should be considered failed as a first-line systemic chemotherapy for progressive disease if progressive disease/recurrence occurs during the course of the neoadjuvant/adjuvant therapy or within 6 months after the end of treatment; c. The previous first-line standard chemotherapy does not contain any small molecular anti-angiogenesis agents or monoclonal antibodies, or any drugs related to tumor immunity;
Key exclusion criteria (32 listed)
- Received a systemic anti-cancer therapy that has been approved or in development, including chemotherapy, radical radiotherapy, bio-immunotherapy, targeted therapy, and treatment by traditional Chinese medicines (if the instructions of the traditional Chinese medicines specifies clear indications for anti-tumor therapy, the patient may be enrolled after an 1 week of washout period), within 4 weeks prior to randomization;
- Received a systemic chemotherapy (a neoadjuvant or adjuvant chemotherapy except those that have not failed within 6 months) other than gemcitabine combined with platinum-based therapy (such as fluorouracil-based chemotherapy) prior to randomization; or received an anti-tumor immunotherapy, such as PD-1 and PD-L1 therapies;
- Received any surgery or invasive treatment/operation (except venous catheterization, puncture and drainage, etc) within 4 weeks prior to randomization;
- Received any major surgical operations within 60 days before randomization, or have any incisions that have not completely healed;
- Received a local anti-tumor therapy such as hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation within 4 weeks prior to randomization;
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 |
|---|---|---|
| SurufatinibAlso: HMPL-012 and SulfatinibPatients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 21-day treatment cycle). | Drug | Active group |
| CapecitabineAlso: XelodaCapecitabine is given at 1250 mg/m2 by oral administration twice a day (BID, one dose each in the morning and evening, with a total dose of 2500 mg/m2 per day) for 2 weeks followed by 1 week of drug interruption. Each course of treatment will last 3 weeks. Capecitabine tablets should be swallowed with water within 30 minutes after a meal. | Drug | Control group |
Primary outcome
Overall survival (OS)
Time frame: 5 months after the last patient enrolled.
Compare the Overall survival (OS) rate between surufatinib group and Capecitabine group.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 5 months after the last patient enrolled.
Objective remission rate (ORR)
Time frame: 5 months after the last patient enrolled.
Disease control rate (DCR)
Time frame: 5 months after the last patient enrolled.
Duration of response (DOR)
Time frame: 5 months after the last patient enrolled.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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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.
Rongjun Liu study director
Hutchison Medipharma Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Surufatinib and Capecitabine in people with Biliary Tract Cancer, run by Hutchison Medipharma Limited at 1 site in China.
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 32 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 13 Feb 2020. 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 China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuefeng Zhao (+86 21 20673222, xuefengz@hmplglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 5 months after the last patient enrolled.). 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 13 Feb 2020.