Clinical Trials

Title Start Date Principal Name
[1005180-2] A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of DigiFab® in Antepartum Subjects with Severe Preeclampsia   Brian Brocato, D.O. 
[1031505-3] A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)   Moh'd Khushman, M.D. 
[433957-19] Cardiovascular Inflammation Reduction Trial (CIRT): A randomized, double-blind, placebo-controlled, event-driven trial of weekly low-dose methotrexate (LDM) in the prevention of cardiovascular events among stable coronary artery disease patie   Mustafa Awan, M.D. 
[526659-9] A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant ChemotherapyWho Convert to Pathologically Nega   Weisi Yan, M.D. 
[552027-11] ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study (Alliance A011106)   Donna L. Dyess, M.D. 
[556164-14] Androgen Deprivation Therapy and High Dose Radiotherapy with or without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial   Weisi Yan, M.D. 
[654939-10] Collection of Whole Blood Specimens from Pregnant Women at Increased Risk for Fetal Chromosomal Abnormality for use in Development of a Noninvasive Prenatal Test in Detection of the Relative Quantity of Chromosomal Material in Circulating Cel   Susan Baker, M.D. 
[677751-4] ANBL1232 Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma. A Groupwide Historically Controlled Phase III Study   Felicia Wilson, M.D. 
[752645-5] AEWS1221: Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma   Felicia Wilson, M.D. 
[794424-7] A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy   Donna L. Dyess, M.D. 
[813731-4] A Randomized Double-Blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in Patients with Prelabor Premature Rupture of Membranes   Brian Brocato, D.O. 
[819237-6] A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mes   Moh'd Khushman, M.D. 
[824258-5] Protocol AALL1231 A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)   Felicia Wilson, M.D. 
[849584-12] A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination with nab-Paclitaxel Plus Gemcitabine Compared with Placebo Plus nab-Paclitaxel and Gemcitabine in   William Taylor, M.D. 
[921786-3] PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growt   Carole Norden, M.D. 
[923977-5] Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB)   Carole Norden, M.D. 
[940957-4] Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer - AIM2CERV   Jennifer Scalici, M.D. 
A Phase 1, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Niraparib Combined with Bevacizumab as Maintenance Treatment in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer 11/29/2017  Rodney Rocconi M.D. 
A phase 1B/2 multi-center, double-blind (principal investigators and study subjects blinded, sponsor unblinded), placebo-controlled, randomized, single-ascending dose study to assess the safety, pharmacokinetics, and pharmacodynamics of DS-1040B in subje   Steve Cordina, M.D. 
A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Estradiol/Norethinedrone Acetate in Subjects with Moderate to Severe Endometriosis-Associated Pain 09/12/2017  Botros Rizk, MD 
A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Bacterial Skin and Skin Structure Infections   Haidee Custodio,, MD 
A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat with Platinum Doublet Chemotherapy versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) 01/09/2018  Moh'd Khushman M.D. 
A Prospective Quality of Life Study in Metastatic Pancreatic Cancer 10/27/2017  Thomas Butler M.D. 
A Randomized Placebo Controlled Phase II Trial of Metformin in Conjunction with Chemotherapy Followed by Metformin Maintenance Therapy in Advanced Stage Ovarian, Fallopian Tube and Primary Peritoneal Cancer 09/12/2017  Rodney Rocconi, MD 
A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo 01/10/2018  Lynn Dyess MD 
A Randomized, Double-Blind, Placebo-Controlled study to Assess the Effects of Bempedoic Acid (ETC-1002) on the occurrence of Major Cardiovascular Events in Patients with, or at High Risk for Cardiovascular Disease who are Statin-Intolerant   Omar, Bassam, MD 
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency 07/21/2017  Christopher Malozzi, DO 
A Randomized, Open-Label Phase 2 Study of Nanoliposomal Irinotecan (nal-IRI)-containing Regimens Versus Nab-Paclitaxel Plus Gemcitabine in Patients with Peviously Untreated, Metastatic Pancreatic Adenocarcinoma 04/25/2018  Moh'd Khushman MD 
A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) who have First Disease Progression During or Following Front-Line Pl   Moh'd Khushman, , MD 
A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) after Neoadjuvant Chemothera   Carole Norden, M.D. 
A Safety and Efficacy Comparison of BLI4700 Bowel Preparation versus an FDA-approved Comparator in Adult Subjects prior to Colonoscopy 12/12/2017  Reynaldo Rodriguez D.O. 
A Single Arm Open-Label Phase IIb Study to Assess the Efficacy and Safety of the Combination of Cediranib and Olaparib Tablets in Women with Recurrent Platinum Resistant Epithelial Ovarian Cancer, Including Fallopian Tube and/or Primary Peritoneal Cancer 03/05/2018  Rodney Rocconi MD 
AALL15P1: A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (IND#TBD, NSC# 102816) to Chemotherapy in Infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A Gene Rearrangement 11/14/2017  Felicia Wilson M.D. 
AAML1331 A Phase III Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide and All-Trans Retinoic Acid A COG Groupwide Phase III Study 02/05/2018  Felicia Wilson, M.D. 
AGCT1531 A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors 01/02/2018  Felicia Wilson, M.D. 
An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Therapy of Investigator's Choice Chemotherapy in Recurrent or Metastatic Platinum-Refractory Cervical Carcinoma 08/11/2017  Rodney Rocconi, MD 
Chronic Hypertension in Pregnancy (CHAP) 05/17/2018  Susan Baker M.D. 
CL-PTL-126 A Randomized, Intra-patient Crossover, Safety, Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients with Advanced Gynecological Cancers 03/14/2017  Rodney Rocconi M.D. 
CX-1158-101 Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor CB-1158 as a Single Agent and in Combination with Immune Checkpoint Therapy in Patients with Advanced/Metastatic Solid Tumors 08/17/2017  Sachin Pai, MD 
EA1131: EA1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy 09/08/2015  Carole Norden, MD 
Efficacy and Safety of Eslicarbazepine Acetate as First Add-on to Levetiracetam or Lamotrigine Monotherapy or as Later Adjunctive Treatment for Subjects with Uncontrolled Partial-onset Seizures: A Multicenter, Open-label, Non-randomized Trial 06/15/2018  Dean Naritoku MD 
Molecular Analysis for Therapy Choice (MATCH) 08/17/2015  Rodney Rocconi M.D. 
Multicenter, prospective, randomized study comparing PillCam Crohn's capsule endoscopy (CE) to ileocolonoscopy (IC) plus MRE for detection of active Crohn's Disease (CD) in the small bowel and colon in subjects with known CD and mucosal disease (BLINK) 11/14/2017  Jack DiPalma M.D. 
Neuroform Atlas Stent System 01/04/2018  Steve Cordina, M.D. 
NRG-HN004: Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) Vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin 01/24/2018  Sachin Pai, M.D. 
Phase II study of pembrolizumab and ipilimumab following initial anti-PD1/L1 antibody 12/27/2017  Arthur Frankel, M.D. 
Phase iii open-label, controlled, randomized, multicenter study evaluating the efficacy and safety of stratagraft® skin tissue in promoting autologous skin tissue regeneration of complex skin defects due to thermal burns 09/12/2017  Steven Kahn, MD 
Preoperative Extended Chemotherapy Vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas   Moh'd Khushman, , MD 
Prospective Evaluation of the ReCell Autologous Cell Harvesting Device for Specific Compassionate use cases   Steven Kahn, MD 
Randomized, Open-label, Phase 3 Trial of Nivolumab plus Brentuximab vedotin versus Brentuximab vedotin alone in Participants with Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma   Sachin Pai MD 
RIN-PH-201 A Multicenter, Randomized, Double-blinded, Placebo- Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease 02/19/2018  Karen Fagan M.D. 
RIN-PH-202 An Open -Label Extension Study of Inhaled Treprostinil in Subjects with pulmonary Hypertension due to Parenchymal Lung Disease 02/19/2018  Karen Fagan 
Southern All of Us -USA 07/06/2018  Errol Crook MD 
Study of Safety & Biological Activity of IP GEN-1 With Neoadjuvant Chemo in Ovarian Cancer 05/08/2018  Rodney Rocconi, MD 

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