Metastatic Pancreatic AdenocarcinomaPhase 1/2NCT02985125
LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy
A Phase 1/2 study testing LEE011 and Everolimus in people with Metastatic Pancreatic Adenocarcinoma, run by Georgetown University at 1 site in United States.
Trial summary
This study is a single-arm, open-label, multi-institutional Phase I/II trial of the combination of LEE011 and everolimus in refractory mPAC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- LEE011 and Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2017to 28 Sep 2020
- Phase
- Phase 1/2
- 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
- Histologically confirmed mPAC (mixed histology is acceptable as long as the predominant histology is pancreatic adenocarcinoma)
- Patient must consent to two mandatory biopsies and have tumor amenable to biopsy
- Measurable disease by RECIST v1.1 criteria (tumor ≥ 1 cm in longest diameter on axial image on CT or MRI and/or lymph node(s) ≥ 1.5 cm in short axis on CT or MRI) on baseline imaging
- Documented progression of disease on at least one 5-FU-based regimen and at least one GEM-based regimen for metastatic disease (progression during or within 3 months of the completion of adjuvant therapy is acceptable)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (see Table 2)
- Age ≥ 18 years
Show all 20Show fewer
- Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease
- Patients with available standard 12-lead ECG with the following parameters at screening (defined as the mean of the triplicate ECGs):
- QTcF interval at screening <450msec
- Resting heart rate 50-90bpm
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3; Platelets ≥100 × 109/L; hemoglobin ≥ 9.0 g/dL
- Patients may have a transfusion of red blood cells to meet the hemoglobin requirement
- Renal function: serum creatinine ≤ 1.5 × upper normal limit of institution's normal range or creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
- Hepatic function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3.0 × the upper normal limit of institution's normal range. Total bilirubin ≤ 1.5 × the upper normal limit of institution's normal range. For subjects with liver metastases, AST and ALT < 5 × the upper normal limit of institution's normal range, and total bilirubin >1.5 - 3.0 x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.
- Partial Thromboplastin Time (PTT) must be ≤ 1.5 × upper normal limit of institution's normal range and International Normalized Ratio (INR) < 1.5. Subjects on anticoagulant (such as warfarin) will be permitted to enroll as long s the INR is in the acceptable therapeutic range as determined by the investigator.
- Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
- Patients must have fully recovered from all effects of surgery. Patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy. Minor procedures requiring "Twilight" sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator.
- Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
- Patient is capable of swallowing pills whole
- Patient is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by the Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
Who cannot join
- Patients previously exposed to, intolerant of, or ineligible for Cyclin-dependent kinase (CDK) inhibitors, Mammalian target of rapamycin (mTOR) inhibitors, and/or their combination
- Prior anti-tumor therapy within 3 weeks of Cycle 1 Day 1 (anti-tumor therapy defined as, but is not limited to, anti-cancer agents (cytotoxic chemotherapy, immunotherapy, and biologic therapy), radiotherapy, and investigational agents), the "wash-out period"
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
- Women who are pregnant or breastfeeding
- Concurrent use of CYP3A4 inhibiting or activating medications
- Concurrent use of an Angiotensin-converting enzyme (ACE) inhibitor (increased risk of angioedema with ACE inhibitors administered in combination with everolimus, seen in approximately 6.8% of patients)
Show all 30Show fewer
- Psychiatric illness or social situation that would limit compliance with study requirements
- Patient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
- Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
- At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
- Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
- Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Patient has a known history of HIV infection or chronic, active Hepatitis B (testing not mandatory).
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormalities, including any of the following:
- History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening
- History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- Documented cardiomyopathy
- Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening
- Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade Atrioventricular block (AV) block (e.g. bifascicular block, Mobitz type II and third-degree AV block)
- Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
- Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication
- Inability to determine the QT interval on screening (QTcF, using Fridericia's correction)
- Systolic blood pressure (SBP) >160 mmHg or <90 mmHg at screening
- Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug (see Table 4 for details):
- Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges
- That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
- Herbal preparations/medications, dietary supplements.
- Patient is currently receiving or has received systemic corticosteroids ≤2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase I/II Study of LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy
This study is a single-arm, open-label, multi-institutional Phase I/II trial of the combination of LEE011 and everolimus in refractory mPAC.
Read the detailed description
This is a single arm, open label Phase I/II study to evaluate the progression free survival at 8 weeks (PFS8week) of the combination of LEE-011 plus everolimus, in patients with metastatic pancreatic cancer refractory to 5-fluorouracil (5-FU) and gemcitabine-based chemotherapy. Previous studies of third-line therapy in mPAC are limited but reveal stable disease in 25-31% of patients with no partial or complete responses (31% of patients in the GVAX/CRS-207 combination vaccine study had stable disease but only 52% of these patients were treated in the third-line setting). It is hoped that the combination of LEE-011 plus everolimus can increase the PFS8weeks to at least 50%, though early stopping rules are in place for lack of efficacy.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- LEE011, Everolimus
- Keywords
- Pancreas, 5-FU, Gemcitabine, LEE011, Everolimus, Refractory, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEE011Drug
Also called ribociclib
Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm.
EverolimusDrug
Also called Afinitor®
Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.
| Study group | Role | What they receive |
|---|---|---|
| Phase I - Dose Level 1 | Experimental | Treatment cycles are 28 days long.
LEE011 (taken orally) - 250mg Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28 Receives: Drug: LEE011; Drug: Everolimus |
| Phase I - Dose Level 2 | Experimental | Treatment cycles are 28 days long.
LEE011 (taken orally) - 300mg Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28 Receives: Drug: LEE011; Drug: Everolimus |
| Phase I - Dose Level -1 | Experimental | Treatment cycles are 28 days long.
LEE011 (taken orally) - 200mg Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28 Receives: Drug: LEE011; Drug: Everolimus |
| Phase I - Dose Level -2 | Experimental | Treatment cycles are 28 days long.
LEE011 (taken orally) - 150mg Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28 Receives: Drug: LEE011; Drug: Everolimus |
| Phase II - Dose | Experimental | Treatment cycles are 28 days long.
LEE011 (taken orally) - the recommended phase II dose Once daily on days 1-21
Everolimus (taken orally) - 2.5mg Once daily on days 1-28 Receives: Drug: LEE011; Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine the Recommended Phase II Dose (RP2D)
Determine the Recommended Phase II dose (RP2D) of LEE011 (ribociclib) in the combination with everolimus in patients with mPAC refractory to 5-FU- and GEM-based chemotherapy based on DLTs within the first 4 weeks of treatment.
Measured: First 4 weeks of treatment
Phase II: Progression-free Survival (PFS) Rate at 8 Weeks
PFS at 8 weeks in a patient with refractory mPAC treated with LEE011 and everolimus, defined as positive if a patient does not have evidence of progressive disease at 8 weeks as measured by expert radiologists using RECIST v1.1 criteria
Measured: 8 weeks
Secondary outcomes (4)
Phase II: Progression-free Survival
PFS in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the time from Cycle 1, Day 1 to progressive disease (as measured by expert radiologists using RECIST v1.1 criteria), death from any cause, or last follow-up, as determined by the investigator of LEE011 and everolimus in patients with mPAC refractory to chemotherapy
Measured: 2 years
Phase II: Overall Survival (OS)
Overall survival (OS) in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the time from Cycle 1, Day 1 to death from any cause or last follow-up
Measured: 2 years
Phase II: Best Response in a Patient Using RECIST v1.1 Criteria
Best response in a patient, defined as the largest percent decrease in tumor size from baseline and categorized as a complete response, partial response, or stable disease by imaging studies, measured by expert radiologists using RECIST v1.1 criteria
Measured: 2 years
Phase II: Number of Adverse Events as Accessed by NCI CTCAE v4.03
Adverse events in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the number of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE v4.03) that occur after Cycle 1, Day 1
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start4 May 2017
- Primary completion24 Jul 2019
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, University of Texas Southwestern Medical Center, Cedars-Sinai Medical Center, Virginia Mason Hospital/Medical Center
- Responsible party
- Sponsor
- Investigators
- Benjamin Weinberg, MD, Study chair, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985125
- Sponsor's protocol ID
- 2016-0232
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2016
- Last updated
- 7 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy
- ClinicalTrials.gov ID
- NCT02985125
- Acronym / sponsor ID
- 2016-0232
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Keywords
- Pancreas, 5-FU, Gemcitabine, LEE011, Everolimus, Refractory, Chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Novartis, University of Texas Southwestern Medical Center, Cedars-Sinai Medical Center, Virginia Mason Hospital/Medical Center
- Study start
- 4 May 2017 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Posted 7 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, open-label, multi-institutional Phase I/II trial of the combination of LEE011 and everolimus in refractory mPAC.
Detailed description
This is a single arm, open label Phase I/II study to evaluate the progression free survival at 8 weeks (PFS8week) of the combination of LEE-011 plus everolimus, in patients with metastatic pancreatic cancer refractory to 5-fluorouracil (5-FU) and gemcitabine-based chemotherapy. Previous studies of third-line therapy in mPAC are limited but reveal stable disease in 25-31% of patients with no partial or complete responses (31% of patients in the GVAX/CRS-207 combination vaccine study had stable disease but only 52% of these patients were treated in the third-line setting). It is hoped that the combination of LEE-011 plus everolimus can increase the PFS8weeks to at least 50%, though early stopping rules are in place for lack of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase I - Dose Level 1 | Experimental | Drug: LEE011, Drug: EverolimusTreatment cycles are 28 days long. LEE011 (taken orally) - 250mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
| Phase I - Dose Level 2 | Experimental | Drug: LEE011, Drug: EverolimusTreatment cycles are 28 days long. LEE011 (taken orally) - 300mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
| Phase I - Dose Level -1 | Experimental | Drug: LEE011, Drug: EverolimusTreatment cycles are 28 days long. LEE011 (taken orally) - 200mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
| Phase I - Dose Level -2 | Experimental | Drug: LEE011, Drug: EverolimusTreatment cycles are 28 days long. LEE011 (taken orally) - 150mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
| Phase II - Dose | Experimental | Drug: LEE011, Drug: EverolimusTreatment cycles are 28 days long. LEE011 (taken orally) - the recommended phase II dose Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically confirmed mPAC (mixed histology is acceptable as long as the predominant histology is pancreatic adenocarcinoma)
- Patient must consent to two mandatory biopsies and have tumor amenable to biopsy
- Measurable disease by RECIST v1.1 criteria (tumor ≥ 1 cm in longest diameter on axial image on CT or MRI and/or lymph node(s) ≥ 1.5 cm in short axis on CT or MRI) on baseline imaging
- Documented progression of disease on at least one 5-FU-based regimen and at least one GEM-based regimen for metastatic disease (progression during or within 3 months of the completion of adjuvant therapy is acceptable)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (see Table 2)
Key exclusion criteria (30 listed)
- Patients previously exposed to, intolerant of, or ineligible for Cyclin-dependent kinase (CDK) inhibitors, Mammalian target of rapamycin (mTOR) inhibitors, and/or their combination
- Prior anti-tumor therapy within 3 weeks of Cycle 1 Day 1 (anti-tumor therapy defined as, but is not limited to, anti-cancer agents (cytotoxic chemotherapy, immunotherapy, and biologic therapy), radiotherapy, and investigational agents), the "wash-out period"
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
- Women who are pregnant or breastfeeding
- Concurrent use of CYP3A4 inhibiting or activating medications
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 |
|---|---|---|
| LEE011Also: ribociclibTreatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. | Drug | Phase I - Dose Level -1, Phase I - Dose Level -2, Phase I - Dose Level 1, Phase I - Dose Level 2, Phase II - Dose |
| EverolimusAlso: Afinitor®Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg. | Drug | Phase I - Dose Level -1, Phase I - Dose Level -2, Phase I - Dose Level 1, Phase I - Dose Level 2, Phase II - Dose |
Primary outcome
Phase I: Determine the Recommended Phase II Dose (RP2D)
Time frame: First 4 weeks of treatment
Determine the Recommended Phase II dose (RP2D) of LEE011 (ribociclib) in the combination with everolimus in patients with mPAC refractory to 5-FU- and GEM-based chemotherapy based on DLTs within the first 4 weeks of treatment.
Phase II: Progression-free Survival (PFS) Rate at 8 Weeks
Time frame: 8 weeks
PFS at 8 weeks in a patient with refractory mPAC treated with LEE011 and everolimus, defined as positive if a patient does not have evidence of progressive disease at 8 weeks as measured by expert radiologists using RECIST v1.1 criteria
4 secondary outcomes
Phase II: Progression-free Survival
Time frame: 2 years
Phase II: Overall Survival (OS)
Time frame: 2 years
Phase II: Best Response in a Patient Using RECIST v1.1 Criteria
Time frame: 2 years
Phase II: Number of Adverse Events as Accessed by NCI CTCAE v4.03
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Benjamin Weinberg, MD study chair
Lombardi Comprehensive 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 1/2 study testing LEE011 and Everolimus in people with Metastatic Pancreatic Adenocarcinoma, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 30 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: finished, as of the sponsor's last update on 7 Apr 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 7 Apr 2026). 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?
Phase I: Determine the Recommended Phase II Dose (RP2D) (time frame: First 4 weeks of treatment). 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?
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 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.