Pancreatic Cancer ResectablePhase 217-134NCT03344172
Pre-Operative Trial (PGHA vs. PGH) for Resectable Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab and Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine in people with Pancreatic Cancer Resectable, run by Nathan Bahary, MD at 1 site in United States.
Trial summary
This is a randomized phase II trial that will examine the ability of Avelumab to improve the clinical activity of a pre-operative regimen of gemcitabine, nab-paclitaxel and hydroxychloroquine in subjects with potentially resectable adenocarcinoma of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pancreatic Cancer Resectable
- What is being tested?
- Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab and Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2017to 30 Apr 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with biopsy-proven adenocarcinoma of the pancreas that is determined to be potentially or borderline resectable by NCCN criteria
- Karnofsky performance status of 70-100%
- No active second malignancy with the exception of basal or squamous cell carcinoma of the skin
- Patient has adequate biological parameters as demonstrated by the following blood counts at screening (obtained ≤14 days prior to randomization)
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L,
- Platelet count ≥100,000/mm3 (100 × 109/L),
Show all 18Show fewer
- Hemoglobin (Hgb) ≥9 g/dL. Patient may receive transfusion as needed.
- Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):
- AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN).
- Total bilirubin ≤ ULN (Except in patients who have Gilbert's Syndrome or patients with recently placed stents for biliary obstruction when bilirubin should be < 1.5 X ULN).
- Serum Creatinine ≤ 1.5mg/dl OR calculated creatinine clearance ≥ 50 for those patients with creatinine greater than 1.5.
- CPK < ULN.
- Patients who have an elevated lipase or amylase and no history of autoimmune pancreatitis, nor physical exam concerning for, or CT correlates of pancreatitis can be enrolled. The elevated levels will serve as the new baseline. Changes above that will be termed toxicities as per CTCAE guidelines with relation to the new baseline.
- PT WNL+/- 15 % unless on active anticoagulation.
- PTT WNL+/- 15 % unless on active anticoagulation (suggested to be drawn peripherally to prevent port drawn elevation due to routine heparin flush of ports).
- Age >18 years
- Patient must be able to swallow enteral medications with no requirement for a feeding tube. Patient's must not have intractable nausea or vomiting which prohibits the patient from oral medications
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Subjects deemed surgically unresectable or subjects unwilling to undergo surgical resection
- Prior use of chemotherapy, radiotherapy, and / or investigational agents for pancreatic cancer
- Any evidence of metastasis to distant organs (liver, lung, peritoneum)
- Symptomatic evidence of gastric outlet obstruction
- Inability to adhere to study and/or follow-up procedures
- History of allergic reactions or hypersensitivity to the study drugs (hydroxychloroquine, gemcitabine, nab-Paclitaxel, Avelumab)
Show all 52Show fewer
- Known or suspected HIV infection
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
- Patients with controlled Type 1 diabetes mellitus who are on a stable insulin regimen are eligible for the study.
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
- Rash must cover < 10% of body surface area.
- Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
- No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis
- History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening
- Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody test at screening, are eligible for the study.
- Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
- Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease, and inherited liver disease
- Active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 12 months prior to initiation of study treatment, or unstable arrhythmia or unstable angina within 3 months prior to initiation of study treatment
- Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
- Prior allogeneic stem cell or organ transplantation including corneal transplant
- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment.
- Placement of a stent or central venous access catheter (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications as determined by the investigator
- Pregnant or breastfeeding, or intending to become pregnant during the study
- The effects of HCQ, gemcitabine, nab-Paclitaxel and Avelumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. All females of childbearing potential (please refer to ECOG's definition in section 5.1) must have a blood test or urine study within two weeks prior to randomization to rule out pregnancy. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. If a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well.
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with Avelumab or within 5 months after the last dose of Avelumab
- Attenuated live vaccines include but are not limited to:
- Tuberculosis (BCG)
- Oral polio vaccine
- Measles, Mumps, Rubella, alone or as part of MMR
- Rotavirus
- Yellow Fever
- Typhoid
- Rabies vaccine should be utilized as recommended by an Infectious Disease specialist
- Nasal flu vaccine
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies
- Known allergy or hypersensitivity to any of the study drugs or any of their excipients
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study, with the following exceptions:
- Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
- Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection).
- Patients requiring the use of enzyme-inducing anti-epileptic medication that includes but not limited to: phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine are excluded
- Patients with previously documented macular degeneration or diabetic retinopathy are excluded
- Baseline EKG with QTc > 470 msec (including subjects on medication). Subjects with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis at MD discretion
- Patients on Coumadin must be willing to switch to an alternative subcutaneous LMWH or oral agent (At PI discretion exceptions can be permitted, as determined on a case by case basis and documented)
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Randomized Phase II Trial of Pre-Operative Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine With or Without Avelumab (PGHA vs. PGH)
This is a randomized phase II trial that will examine the ability of Avelumab to improve the clinical activity of a pre-operative regimen of gemcitabine, nab-paclitaxel and hydroxychloroquine in subjects with potentially resectable adenocarcinoma of the pancreas.
Read the detailed description
This is a phase II, non-blinded, adaptively randomized trial. Patients with PDA are evaluated prior to protocol entry by standard of care testing, including EUS, contrast-enhanced helical abdominal CT scan, or MRI. Patients meeting NCCN criteria for potentially resectable (borderline or resectable) tumors will be eligible. Subjects are randomized to receive either 2 cycles of PGH - gemcitabine and nab-paclitaxel (1000 mg/m2 \& 125 mg/m2, respectively: days 1, 8, and 15) plus oral HCQ (1200 mg PO daily) - or PGH plus Avelumab (PGHA; days 1 and 15 of each 28-day cycle), by means of response-adaptive randomization based on Grade IIB or greater histologic response.
Surgical exploration and pancreatectomy is performed if technically feasible and all toxicities have resolved. HCQ is taken until the evening before surgery. Avelumab is administered every two weeks until up to one week prior to the date of surgery. The Study Coordinator informs subjects of the date of operation. Following successful surgical removal of tumors, patients are then be free to pursue standard of care adjuvant therapy options, at the discretion of their treating physician.
- Conditions
- Pancreatic Cancer Resectable
- Being tested
- Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab, Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and AvelumabDrug
Also called PGHA
Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)
Gemcitabine, Nab-Paclitaxel, and hydroxychloroquineDrug
Also called PGH
Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery
| Study group | Role | What they receive |
|---|---|---|
| PGHA | Experimental | Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab Receives: Drug: Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab |
| PGH | Experimental | Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Receives: Drug: Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Grade IIb or Higher Histolopathologic Responses
Number of grade IIb+lll+lllm+IV+lVm responses / total number of all grade histolopathologic responses. Histoligic appearance will be assess per the Grading System for Pathological Response: Grade I - Characteristic cytologic changes of malignancy present, but little (< 10%) or no tumor cell destruction is evident; Grade II - Characteristic cytologic changes of malignancy; 10% to 90% of tumor cells are destroyed; Grade IIa - Destruction of 10% to 50% of tumor cells; Grade IIb - Destruction of 51% to 90% of tumor cells; Grade III - Few (< 10%) viable-appearing tumor cells are present; Grade IIIm - Sizable pools of mucin present; Grade IV - No viable tumor cells present; Grade IVm - Acellular pools of mucin present.
Measured: up to 3 years
Secondary outcomes (5)
Change in CA19-9 Levels
Levels of CA19-9 (tumor marker) in preoperative and postoperative tissues will be determined. Higher levels of CA19-9 are associated with progressive disease.
Measured: Up to 3 years
Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment
Percentage of participants that experienced an adverse event at least possibly related to study treatment, by Grade. Adverse events were evaluated per per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Measured: Up to 6 months
Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment
Percentage of participants that experienced an adverse event at least probably related to study treatment, by Grade. Adverse events were evaluated per per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Measured: Up to 6 months
Autophagy Biomarker Levels by Histopathological Response
Autophagy biomarker levels in blood by histopathological response (per the Grading System for Pathological Response)
Measured: Up to 3 years
Change in Coagulation Index (CI)
Comparison of the preoperative and postoperative Thromboelastogram (TEG) Coagulation Index (CI) profile. TEG is an overall assessment of coagulability, quantitatively measures the ability of whole blood to form a clot. Cancer patients are at greater risk for thromboembolism compared to the normal population due to tumor burden and systemic therapies.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start13 Dec 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Why it stopped: Suspected Serious Adverse Events related to treatment
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 Pancreatic Cancer ResectableStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathan Bahary, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Nathan Bahary, MD, University of Pittsburgh
- Investigators
- Nathan Bahary, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344172
- Sponsor's protocol ID
- HCC# 17-134
- Other IDs
- R01CA181450
- Acronym
- 17-134
- Status last verified
- Apr 2020
- First submitted
- 3 Oct 2017
- Last updated
- 14 May 2020
- 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 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Pre-Operative Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine With or Without Avelumab (PGHA vs. PGH)
- ClinicalTrials.gov ID
- NCT03344172
- Acronym / sponsor ID
- 17-134 / HCC# 17-134
- Conditions
- Pancreatic Cancer Resectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspected Serious Adverse Events related to treatment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nathan Bahary, MDUniversity, hospital or other
- Collaborators
- Pfizer, National Cancer Institute (NCI)
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 14 May 2020
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 phase II trial that will examine the ability of Avelumab to improve the clinical activity of a pre-operative regimen of gemcitabine, nab-paclitaxel and hydroxychloroquine in subjects with potentially resectable adenocarcinoma of the pancreas.
Detailed description
This is a phase II, non-blinded, adaptively randomized trial. Patients with PDA are evaluated prior to protocol entry by standard of care testing, including EUS, contrast-enhanced helical abdominal CT scan, or MRI. Patients meeting NCCN criteria for potentially resectable (borderline or resectable) tumors will be eligible. Subjects are randomized to receive either 2 cycles of PGH - gemcitabine and nab-paclitaxel (1000 mg/m2 \& 125 mg/m2, respectively: days 1, 8, and 15) plus oral HCQ (1200 mg PO daily) - or PGH plus Avelumab (PGHA; days 1 and 15 of each 28-day cycle), by means of response-adaptive randomization based on Grade IIB or greater histologic response.
Surgical exploration and pancreatectomy is performed if technically feasible and all toxicities have resolved. HCQ is taken until the evening before surgery. Avelumab is administered every two weeks until up to one week prior to the date of surgery. The Study Coordinator informs subjects of the date of operation. Following successful surgical removal of tumors, patients are then be free to pursue standard of care adjuvant therapy options, at the discretion of their treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGHA | Experimental | Drug: Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and AvelumabGemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab |
| PGH | Experimental | Drug: Gemcitabine, Nab-Paclitaxel, and hydroxychloroquineGemcitabine, Nab-Paclitaxel, and hydroxychloroquine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants with biopsy-proven adenocarcinoma of the pancreas that is determined to be potentially or borderline resectable by NCCN criteria
- Karnofsky performance status of 70-100%
- No active second malignancy with the exception of basal or squamous cell carcinoma of the skin
- Patient has adequate biological parameters as demonstrated by the following blood counts at screening (obtained ≤14 days prior to randomization)
- Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):
Key exclusion criteria (52 listed)
- Subjects deemed surgically unresectable or subjects unwilling to undergo surgical resection
- Prior use of chemotherapy, radiotherapy, and / or investigational agents for pancreatic cancer
- Any evidence of metastasis to distant organs (liver, lung, peritoneum)
- Symptomatic evidence of gastric outlet obstruction
- Inability to adhere to study and/or follow-up procedures
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 |
|---|---|---|
| Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and AvelumabAlso: PGHADays 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg) | Drug | PGHA |
| Gemcitabine, Nab-Paclitaxel, and hydroxychloroquineAlso: PGHDays 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery | Drug | PGH |
Primary outcome
Proportion of Grade IIb or Higher Histolopathologic Responses
Time frame: up to 3 years
Number of grade IIb+lll+lllm+IV+lVm responses / total number of all grade histolopathologic responses. Histoligic appearance will be assess per the Grading System for Pathological Response: Grade I - Characteristic cytologic changes of malignancy present, but little (< 10%) or no tumor cell destruction is evident; Grade II - Characteristic cytologic changes of malignancy; 10% to 90% of tumor cells are destroyed; Grade IIa - Destruction of 10% to 50% of tumor cells; Grade IIb - Destruction of 51% to 90% of tumor cells; Grade III - Few (< 10%) viable-appearing tumor cells are present; Grade IIIm - Sizable pools of mucin present; Grade IV - No viable tumor cells present; Grade IVm - Acellular pools of mucin present.
5 secondary outcomes
Change in CA19-9 Levels
Time frame: Up to 3 years
Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment
Time frame: Up to 6 months
Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment
Time frame: Up to 6 months
Autophagy Biomarker Levels by Histopathological Response
Time frame: Up to 3 years
Change in Coagulation Index (CI)
Time frame: up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- 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.
Nathan Bahary, MD principal investigator
UPMC Hillman 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 Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab and Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine in people with Pancreatic Cancer Resectable, run by Nathan Bahary, MD 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 18 inclusion and 52 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 14 May 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 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 14 May 2020). 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?
Proportion of Grade IIb or Higher Histolopathologic Responses (time frame: up to 3 years). 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 14 May 2020.