chufangao/CTO huggingface dataset:
Clinical trial NCT03288493: P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Official title: Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P BCMA-101 in Subjects With Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME)
Sponsor: Poseida Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Phase I portion of the study was completed. The phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.
Enrollment: 105.0 (ACTUAL)
Number of arms: 8.0
Start date: 2017-09-20
Primary completion date: 2022-04-27
Completion date: 2022-04-27
Clinical trial NCT04033159: Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
Official title: A Phase 1/2 Trial on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of DYN101 in Patients ≥ 16 Years of Age With Centronuclear Myopathies Caused by Mutations in DNM2 or MTM1.
Acronym: Unite-CNM
Sponsor: Dynacure (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Based on tolerability findings at the low dose level thus far, continuation of dosing or even dose escalation is not possible.
Enrollment: 14.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-01-09
Primary completion date: 2022-06-22
Completion date: 2022-06-22
Plan to share individual participant data: NO
Clinical trial NCT03336216: A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
Official title: A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination With Nivolumab (BMS-936558) With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 205.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-12-18
Primary completion date: 2023-06-01
Completion date: 2023-06-01
Clinical trial NCT05886257: Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T
Official title: Candonilimab Plus Bevacizumab as Second-line Treatment for Patients With Advanced Hepatocellular Carcinoma Who Progressed on Atezolizumab Plus Bevacizumab: a Single Arm, Phase 2 Trial
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Protocol adjustment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-07
Primary completion date: 2023-03-31
Completion date: 2023-03-31
Clinical trial NCT03960151: Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
Official title: Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Compound was sold by funder and development ceased.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-31
Primary completion date: 2021-05-31
Completion date: 2022-03-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04220411: A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis (AD)
Official title: A Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Healthy Subjects, and Subjects With Mild to Moderate Atopic Dermatitis
Sponsor: Arjil Pharmaceuticals LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to the two AEs in Phase IIa study, recruiting was stopped for safety sake. The study was currently terminated.
Enrollment: 17.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-12-08
Primary completion date: 2021-12-29
Completion date: 2022-06-13
Baseline population: Final Visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. One subject in Phase II was early terminated at Visit 5.
Plan to share individual participant data: NO
Clinical trial NCT03353753: Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
Official title: A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies
Acronym: INVICTUS
Sponsor: Deciphera Pharmaceuticals, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 129.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-27
Primary completion date: 2019-05-31
Completion date: 2022-05-11
Baseline population: The baseline analysis population was the intent-to-treat (ITT) population, defined as those who signed the ICF and were randomized
Plan to share individual participant data: NO
Clinical trial NCT04342182: Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study)
Official title: Convalescent Plasma Therapy From Recovered Covid-19 Patients as Therapy for Hospitalized Patients With Covid-19
Acronym: ConCoVid-19
Sponsor: Erasmus Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: new insights into COVID19 pathogenesis
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-08
Primary completion date: 2020-07-01
Completion date: 2020-09-30
Clinical trial NCT04697693: Antidepressant Response in Older Adults With Comorbid PTSD and MDD
Official title: Antidepressant Response in Older Adults With Comorbid PTSD and MDD
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Unable to recruit participants in a timely fashion due to COVID pandemic
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-03
Primary completion date: 2021-05-20
Completion date: 2021-05-20
Limitations and caveats: The study had a planned accrual of 25 participants but only accrued 1 participant due to challenges in recruiting during the pandemic.
Plan to share individual participant data: NO
Clinical trial NCT03172897: Low-dose Dexmedetomidine in Mechanically Ventilated ICU Patients
Official title: Low-dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Patients in Intensive Care Unit: a Multicenter, Randomised, Double-blinded, Placebo-controlled Trial
Sponsor: Peking University First Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: The trial was stopped because of difficulty in recruiting patients (another trial had similar inclusion/exclusion criteria). No patients was recruited in this trial.
Enrollment: 260.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2017-08-20
Primary completion date: 2017-08-21
Completion date: 2022-11-30
Plan to share individual participant data: NO
Clinical trial NCT03847389: Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
Official title: Open-Label Study of the Pharmacokinetics and Safety Including HPA Axis Suppression Potential of Clobetasol Topical Oil in Pediatric Subjects With Moderate to Severe Atopic Dermatitis
Sponsor: Hill Dermaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Difficulty in enrollment and COVID-19 pandemic.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-09
Primary completion date: 2020-05-02
Completion date: 2020-07-28
Baseline population: Study was terminated prior to enrolling participants in cohort 2 or cohort 3.
Limitations and caveats: The study was terminated early due to the COVID pandemic with very low subject enrollment. Due to the small number of subjects that completed when the study was prematurely terminated, pharmacokinetic, exploratory, sensitivity, as well as some safety analyses was not completed under the SAP.
Clinical trial NCT03466021: Effects of Liraglutide in Chronic Obstructive Pulmonary Disease
Official title: Effects of GLP-1 Receptor Agonist Treatment on Pulmonary Function and Quality of Life in Obese Patients With Chronic Obstructive Pulmonary Disease.
Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-01
Primary completion date: 2020-05-31
Completion date: 2020-05-31
Clinical trial NCT03061110: Stromal Vascular Fraction for Treatment of Xerostomia
Official title: Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System® (Icellator) Autologous Adipose Stromal Vascular Fraction Cells as a Treatment for Post-Irradiated Induced Xerostomia in Head and Neck Cancer Patients
Sponsor: Midwestern Regional Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Internal funding not awarded.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-01
Primary completion date: 2020-12-28
Completion date: 2020-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03604289: Angiotensin 1-7 in Obesity Hypertension
Official title: Cardiovascular Effects of Angiotensin 1-7 in Obesity Hypertension
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Funding terminated
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-01
Primary completion date: 2023-05-03
Completion date: 2023-06-03
Clinical trial NCT05160402: Evaluation of IGM-6268 in Healthy Volunteers
Official title: A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Volunteers
Sponsor: IGM Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 54.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-12-07
Primary completion date: 2022-06-15
Completion date: 2022-08-18
Clinical trial NCT05094934: A Research Study Looking Into Levels of the Medicine NNC0385-0434 in the Body and How Well it is Tolerated in Participants With Impaired Kidney Function Compared to Participants With Normal Kidney Function
Official title: Investigation of Pharmacokinetics, Safety and Tolerability of Oral NNC0385-0434 in Participants With Various Degrees of Impaired Renal Function and in Participants With Normal Renal Function
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 60.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-11-09
Primary completion date: 2022-07-15
Completion date: 2022-08-24
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04057937: A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Palmoplantar Pustulosis in Japan
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-16
Primary completion date: 2021-01-18
Completion date: 2021-06-07
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT03998423: Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease
Official title: Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease
Acronym: AMBITION
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: SARS-CoV-2 has been detected in fecal material. Although FMT is screened for SARS-CoV-2, the team decided to end the study to minimize risk to participants.
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-14
Primary completion date: 2020-07-14
Completion date: 2020-07-14
Plan to share individual participant data: NO
Clinical trial NCT03991884: Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia
Official title: A Phase I Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Escalating Doses of Inotuzumab Ozogamicin (DA-EPOCH-InO) in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-09-24
Primary completion date: 2022-10-20
Completion date: 2023-06-28
Plan to share individual participant data: NO
Clinical trial NCT03635437: Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes
Official title: A Phase I/II, 3-Arm, Open Label, Single Centre Study to Investigate the Safety and Effect of Oral GABA Therapy on Beta-Cell Regeneration in Type 1-diabetes Patients
Sponsor: Uppsala University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-05
Primary completion date: 2022-09-27
Completion date: 2022-09-27
Clinical trial NCT04511026: Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
Official title: Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Efficacy
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-20
Primary completion date: 2021-06-10
Completion date: 2021-06-10
Limitations and caveats: This study did not meet its planned enrollment and did not achieve statistical power.
Plan to share individual participant data: NO
Clinical trial NCT03738397: A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
Official title: A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis
Acronym: Heads Up
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 673.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-21
Primary completion date: 2020-08-27
Completion date: 2020-12-09
Baseline population: The intent-to-treat (ITT) population includes all randomized participants according to the treatment groups that they were randomized to.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing, please refer to the link below.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04274166: Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum
Official title: The Efficacy and Safety of Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Contracting never completed, closed the IRB
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-31
Primary completion date: 2021-12-31
Completion date: 2022-04-30
Plan to share individual participant data: NO
Clinical trial NCT02419664: Ga-68-DOTATOC -PET in the Management of Pituitary Tumours
Official title: Ga-68-DOTATOC -PET in the Management of Pituitary Tumours
Sponsor: Göteborg University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The hypothesis we had that we could predict the growth rate from PET uptake could not be confirmer and 3-year follow up was no longer considered motivated
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-01-31
Primary completion date: 2022-01-13
Completion date: 2022-01-13
Clinical trial NCT01554618: Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
Official title: A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 84.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-12-02
Primary completion date: 2020-05-06
Completion date: 2021-05-05
Baseline population: Baseline analysis performed on Intent-to-Treat (ITT) Analysis Set which consisted of all randomized patients who received at least 1 dose of randomized study medication.
Limitations and caveats: For statistical analyses of change from baseline in HOMA-B and HOMA-S, due to the limited sample size (n=14 and n=7 in the extenatide and placebo groups, respectively) it is difficult to accurately interpret these data. The study design included an extended safety follow-up period which continued for up to 3 years or until the increase in height between two 6-month interval visits was \<5 mm (whichever came first). No study medication was administered during the extended safety follow-up period.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04209179: A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism
Official title: A Randomized, Double-Blind, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PCO371 in Patients With Hypoparathyroidism
Sponsor: Chugai Pharmaceutical (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated on the basis of the currently uncertain risk-benefit balance for the patients, and the strategic position of the development program
Enrollment: 5.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-07-23
Primary completion date: 2020-12-28
Completion date: 2021-05-25
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
Clinical trial NCT02282917: Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma
Official title: Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma
Sponsor: Massachusetts Eye and Ear Infirmary (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Drug manufacturing logistics; lack of access to drug supply
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-12-31
Primary completion date: 2017-05-30
Completion date: 2021-01-04
Baseline population: Two participants were withdrawn from the study prior to the administration of the study drug: one was deemed ineligible, and one chose not to participate.
Limitations and caveats: The supplier of AR-42 was unable to continue to supply drugs after 2017. We elected to present the data on five of the originally planned 20 patients. Accrual was also limited by patient willingness to accept potential additional peri-operative risk without a reasonable likelihood of benefit from only 3 weeks of therapy with AR-42. Other limitations include possible selection bias, lack of control subjects, and the inability to perform meaningful statistical analysis.
Plan to share individual participant data: NO