Pancreatic CancerPhase 2NCT00640978
Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer
A Phase 2 study testing RAD001 and Erlotinib 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 the combination of RAD001 and erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this drug combination will also be studied. 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?
- RAD001 and Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is unresectable or metastatic.
- Patients must have received at least one prior chemotherapy regimen for unresectable/ metastatic disease. There is no limit to number of prior regimens. Prior erlotinib therapy is allowed.
- Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy. Patients must have recovered from the acute toxicities of any prior therapy to NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 </= Grade 1.
- Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of erlotinib administered in combination with RAD001 in patients < 18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients must have at least one measurable site of disease according to Response Evaluation Criteria In Solid Tumors (RECIST). This site must be outside a radiation field.
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- Adequate hematologic, hepatic and renal parameters: leukocytes =/>3,000/ul, absolute neutrophil count =/>1,500/ul, platelets =/>100,000/ul, hemoglobin =/>9g/dL, total bilirubin </= 1.5 mg/dl, aspartate aminotransferase (AST) </=230 and alanine aminotransferase (ALT) </=280 IU/L for subjects with documented liver metastases; AST </=115 and ALT </=140 IU/L for subjects without evidence of liver metastases, creatinine </=1.5 mg/dl in males, </= 1.2 mg/dl in females.
- Women of childbearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry for the duration of study treatment and 30 days after the end of treatment. WOCBP is defined as a woman who has not been naturally postmenopausal for at least 12 consecutive months or no previous surgical sterilization. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions and are therefore not considered effective for this study. WOCBP must provide a negative pregnancy test (serum or urine) within 7 days prior to treatment.
- (Continuation of # 8) Acceptable contraception includes double-barrier methods (any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap, IUD).
- Signed written informed consent document. Written informed consent must be obtained prior to any evaluations being performed solely for the purposes of screening for eligibility for this study.
Who cannot join
- Prior treatment with any investigational drug within the preceding 2 weeks
- Chronic treatment with systemic steroids or another immunosuppressive agent. Patients can not receive immunization with attenuated live vaccines within one week of study entry or during study period
- Limits for fasting lipids must be: cholesterol </= 300mg/dL and triglyceride </= 2.5 times upper limits of normal (ULN). Patients may be allowed to enroll on the trial after initiation of lipid lowering agents
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases (Brain imaging studies are not required if the patient does not have a history of brain metastases and has no neurological signs or symptoms)
- Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction </= 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia; severely impaired lung function (oxygen dependent, Common Terminology Criteria (CTC) Grade 3 or 4 dyspnea); uncontrolled diabetes as defined by fasting serum glucose >1.5 times ULN; any active (acute or chronic) or uncontrolled infection / disorders
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- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy ; liver disease such as cirrhosis, known chronic active hepatitis or chronic persistent hepatitis; A known history of HIV seropositivity
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 and/or erlotinib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- Patients with an active, bleeding diathesis (if coumarin is used, weekly monitoring is recommended)
- Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Acceptable contraception includes double-barrier methods (any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap, intrauterine device [IUD]).
- Patients who have received prior treatment with an mTor inhibitor
- Patients with a known hypersensitivity to erlotinib, RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study of Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer
The goal of this clinical research study is to learn if the combination of RAD001 and erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this drug combination will also be studied.
Primary Objectives:
-Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001 in patients who have received previous treatment for advanced pancreatic cancer.
Secondary Objectives:
- Determine the progression-free survival (PFS).
- Determine the response rate (RR).
Read the detailed description
The Study Drugs:
RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take erlotinib hydrochloride by mouth every day of each 28-day study "cycle". You should take erlotinib hydrochloride once a day in the morning with 1 cup (about 8 oz.) of water. Erlotinib hydrochloride should be taken at least 1 hour before or 2 hours after you have any food, vitamins, iron supplements, or other non-prescription drugs.
On Days 1, 8, 15, and 22 of each cycle, you will take RAD001 by mouth in the morning. You should either take the study drug on an empty stomach with 2 cups (about 16 oz.) of water or after a low-fat meal. You should not take the study drug after large fatty meals because fatty meals lower the amount of the study drug in your body. Some examples of a low-fat meal include cereal with fat-free milk, a low-fat muffin, toast, or a bagel with fat-free spread, or fruit salad.
On days when you take both RAD001 and erlotinib hydrochloride, RAD001 should be taken right before erlotinib hydrochloride.
If you experience intolerable side effects, you must call your doctor right away. The doctor may tell you to stop taking the study drugs or to take fewer pills. The study drugs may also be stopped completely, if your doctor thinks it is necessary.
Study Visits:
On Day 1 of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a performance status evaluation.
- Blood (about 2 tablespoons) and urine will for collected for routine tests. You should be fasting at the time of the blood draw. You should not eat or drink anything except water after midnight the night before.
- You will be asked about any drugs you may be taking or have taken since your last visit.
On Day 8 of Cycle 1, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 tablespoons) and urine will be collected for routine tests. You should be fasting at the time of the blood draw. You should not eat or drink anything except water after midnight the night before.
- You will be asked about any drugs you may be taking or have taken since your last visit.
At the end of every even cycle (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan to check the status of the disease. The scans will be the same type that you had during screening.
Length of Study:
You may remain on study as long as you are benefitting. You will be taken off study early if the disease gets worse, you have intolerable side effects, or if your doctor decides that it is in your best interest to stop treatment.
End-of-Study Visit:
About 14 days after the last dose of study drug, you will have an end-of-study visit. The following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a performance status evaluation.
- Blood (about 2-3 tablespoons) and urine will be collected for routine tests. You should be fasting at the time of the blood draw. You should not eat or drink anything except water after midnight the night before.
- If you have not had them within the last 4 weeks, you will have a CT or MRI scan to check the status of the disease. The scans will be the same type that you had during screening.
Long-Term Follow-Up:
After you go off study, you will be asked how you are doing once a month for the first 6 months from the beginning of the study treatment. Then you will be asked how you are doing every 3 months from then on. This may be done either by phone contact or a clinic visit and will take about 15-30 minutes.
This is an investigational study. Erlotinib hydrochloride in combination with gemcitabine is commercially available and FDA approved for the treatment of pancreatic cancer. RAD001 is not FDA approved or commercially available. At this time, the combination of these drugs is only being used in research.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Pancreatic Cancer
- Being tested
- RAD001, Erlotinib
- Keywords
- Pancreatic Cancer, Advanced Pancreatic Cancer, Unresectable, Metastatic, RAD001, Everolimus, Erlotinib, OSI-774, Erlotinib Hydrochloride, Tarceva
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
Also called Everolimus
30 mg orally weekly for 4 weeks
ErlotinibDrug
Also called Erlotinib Hydrochloride, OSI-774, Tarceva
150 mg by mouth daily for 28 Days
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib + RAD001 | Experimental | Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks Receives: Drug: RAD001; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Surviving at 6 Months
Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Significant Adverse Effects - Futility
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.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, OSI Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Milind Javle, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640978
- Sponsor's protocol ID
- 2007-0666
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2008
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Javle MM, Shroff RT, Xiong H, Varadhachary GA, Fogelman D, Reddy SA, Davis D, Zhang Y, Wolff RA, Abbruzzese JL. Inhibition of the mammalian target of rapamycin (mTOR) in advanced pancreatic cancer: results of two phase II studies. BMC Cancer. 2010 Jul 14;10:368. doi: 10.1186/1471-2407-10-368.
PubMed 20630061
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Erlotinib and RAD001 (Everolimus) in Patients With Previously Treated Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00640978
- Acronym / sponsor ID
- 2007-0666
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Advanced Pancreatic Cancer, Unresectable, Metastatic, RAD001, Everolimus, Erlotinib, OSI-774
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant Adverse Effects - Futility
- Enrolment
- 16 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis, OSI Pharmaceuticals
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Posted 27 Sep 2011
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 the combination of RAD001 and erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this drug combination will also be studied.
Primary Objectives:
-Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001 in patients who have received previous treatment for advanced pancreatic cancer.
Secondary Objectives:
- Determine the progression-free survival (PFS).
- Determine the response rate (RR).
Detailed description
The Study Drugs:
RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take erlotinib hydrochloride by mouth every day of each 28-day study "cycle". You should take erlotinib hydrochloride once a day in the morning with 1 cup (about 8 oz.) of water. Erlotinib hydrochloride should be taken at least 1 hour before or 2 hours after you have any food, vitamins, iron supplements, or other non-prescription drugs.
On Days 1, 8, 15, and 22 of each cycle, you will take RAD001 by mouth in the morning. You should either take the study drug on an empty stomach with 2 cups (about 16 oz.) of water or after a low-fat meal. You should not take the study drug after large fatty meals because fatty meals lower the amount of the study drug in your body. Some examples of a low-fat meal include cereal with fat-free milk, a low-fat muffin, toast, or a bagel with fat-free spread, or fruit salad.
On days when you take both RAD001 and erlotinib hydrochloride, RAD001 should be taken right before erlotinib hydrochloride.
If you experience intolerable side effects, you must call your doctor right away. The doctor may tell you to stop taking the study drugs or to take fewer pills. The study drugs may also be stopped completely, if your doctor thinks it is necessary.
Study Visits:
On Day 1 of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a performance status evaluation.
- Blood (about 2 tablespoons) and urine will for collected for routine tests. You should be fasting at the time of the blood draw. You should not eat or drink anything except water after midnight the night before.
- You will be asked about any drugs you may be taking or have taken since your last visit.
On Day 8 of Cycle 1, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 2 tablespoons) and urine will be collected for routine tests. You should be fasting at the time of the blood draw. You should not eat or drink anything except water after midnight the night before.
- You will be asked about any drugs you may be taking or have taken since your last visit.
At the end of every even cycle (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan to check the status of the disease. The scans will be the same type that you had during screening.
Length of Study:
You may remain on study as long as you are benefitting. You will be taken off study early if the disease gets worse, you have intolerable side effects, or if your doctor decides that it is in your best interest to stop treatment.
End-of-Study Visit:
About 14 days after the last dose of study drug, you will have an end-of-study visit. The following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will have a performance status evaluation.
- Blood (about 2-3 tablespoons) and urine will be collected for routine tests. You should be fasting at the time of the blood draw. You should not eat or drink anything except water after midnight the night before.
- If you have not had them within the last 4 weeks, you will have a CT or MRI scan to check the status of the disease. The scans will be the same type that you had during screening.
Long-Term Follow-Up:
After you go off study, you will be asked how you are doing once a month for the first 6 months from the beginning of the study treatment. Then you will be asked how you are doing every 3 months from then on. This may be done either by phone contact or a clinic visit and will take about 15-30 minutes.
This is an investigational study. Erlotinib hydrochloride in combination with gemcitabine is commercially available and FDA approved for the treatment of pancreatic cancer. RAD001 is not FDA approved or commercially available. At this time, the combination of these drugs is only being used in research.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib + RAD001 | Experimental | Drug: RAD001, Drug: ErlotinibErlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is unresectable or metastatic.
- Patients must have received at least one prior chemotherapy regimen for unresectable/ metastatic disease. There is no limit to number of prior regimens. Prior erlotinib therapy is allowed.
- Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy. Patients must have recovered from the acute toxicities of any prior therapy to NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 </= Grade 1.
- Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of erlotinib administered in combination with RAD001 in patients < 18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Key exclusion criteria (12 listed)
- Prior treatment with any investigational drug within the preceding 2 weeks
- Chronic treatment with systemic steroids or another immunosuppressive agent. Patients can not receive immunization with attenuated live vaccines within one week of study entry or during study period
- Limits for fasting lipids must be: cholesterol </= 300mg/dL and triglyceride </= 2.5 times upper limits of normal (ULN). Patients may be allowed to enroll on the trial after initiation of lipid lowering agents
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases (Brain imaging studies are not required if the patient does not have a history of brain metastases and has no neurological signs or symptoms)
- Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
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 |
|---|---|---|
| RAD001Also: Everolimus30 mg orally weekly for 4 weeks | Drug | Erlotinib + RAD001 |
| ErlotinibAlso: Erlotinib Hydrochloride, OSI-774, Tarceva150 mg by mouth daily for 28 Days | Drug | Erlotinib + RAD001 |
Primary outcome
Number of Participants Surviving at 6 Months
Time frame: 6 months
Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20630061Javle MM, Shroff RT, Xiong H, Varadhachary GA, Fogelman D, Reddy SA, Davis D, Zhang Y, Wolff RA, Abbruzzese JL. Inhibition of the mammalian target of rapamycin (mTOR) in advanced pancreatic cancer: results of two phase II studies. BMC Cancer. 2010 Jul 14;10:368. doi: 10.1186/1471-2407-10-368.
- UT MD Anderson Cancer CenterLink 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.
Milind Javle, 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 Phase 2 study testing RAD001 and Erlotinib 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 12 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 7 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Sep 2011). 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 Participants Surviving at 6 Months (time frame: 6 months). 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 NCT00640978, 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 7 Jul 2026.