Brick Office: 732-840-8880

Neptune Office: 732-206-6226

Toms River Office: 732-244-1440

Whiting Office: 732-840-8880

Clinical Trials

For a complete list of clinical trials currently available at our site, call Kari at 732-840-8880 x-117

Listed below by disease state are some of the clinical trials offered at NJHOA

Updated September 2020

Acute Myeloid Leukemia (AML)

Bio Path BP1001-201-AML
A Phase IIa single-arm, open-label, two-stage clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of BP1001 (a liposomal Grb2 antisense oligonucleotide) in combination with low-dose Cytarabine (LDAC) in patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive induction therapy

Multiple Cancers

MT Group MTG-022
Translational Medicine: Discovery and evaluation of biomarker/pharmocogenomics for the diagnosis and personalization management of patients

Seer-020102
A prospective blood sample collection study to evaluate a panel of protein-based biomarkers

Klus Pharma, Inc.. KL166-I-01
Phase I-II, First-in-Human Study of A166 in Patients with Locally Advanced/Metastatic Solid Tumors which are Human Epidermal Growth Factor Receptor 2 (HER2)-Positive who did not Respond or Stopped Responding to Approved Therapies and Patients with HER2 Positive (by ISH or NGS) or Low Expressing (by IHC) Solid Tumors who did not Respond or Stopped Responding to Approved Therapies

Non-Small Cell Lung Cancer (NSCLC)

Helsinn ANAM-17-21
A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Anamorelin HCI for the treatment of malignancy associated weight loss and anorexia in adult patients with advanced non-small cell lung cancer (NSCLC)

ARC7 AB154CSP0002
A phase 2 Open-Label study to evaluate the safety and efficacy of AB122 and AB928 in 1st line NSCLC

Febrile Neutropenia (Breast Cancer, Lung Cancer, Prostate Cancer, NHL)

Amgen 20170758 – closed to enrollment
A prospective observational study to estimate the incidence of febrile neutropenia (FN) among subjects with non-myeloid malignancies at high risk for FN and receiving Neulasta® (pegfilgrasim) Onpro® kit or other physician choice options for prophylaxis of FN

Non-Hodgkin’s Lymphoma / Chronic Lymphocytic Leukemia / Hodgkin’s Lymphoma

Astra Zeneca/Acerta ACE-CL-311
A randomized, multicenter, open-label, phase 3 study to compare the efficacy and safety of Acalabrutinib (ACP-196) in combination with Venetoclax with and without Obinutuzumab compared to investigator’s choice of chemoimmunotherapy in subjects with previously untreated chronic lymphocyctic leukemia without del(17p) or TP53 mutation

Seattle Genetics SGN35-027
Phase IV Multiple Part Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects To assess the CR rate at end-of-treatment (EOT) with brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine (AN+AD) in subjects with previously untreated advanced cHL

Beigene BGB-3111-305
A phase 3, randomized study of Zanubrutinib (BGB-3111) compared with Ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

InnoCare Pharma Inc. ICP-CL-00107
Phase I, open-label, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of a novel BTK inhibitor, ICP-022. During this study, dose escalation will be conducted in patients diagnosed with refractory/relapsed (r/r) B-cell malignancies including only patients with Grades 1-3a follicular lymphoma (FL); marginal zone lymphoma (MZL); mantle cell lymphoma (MCL); and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

Hutchison Medi Pharma 2018-523-00US1A
Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Patients with Relapsed or Refractory Lymphoma

MEI Pharma, Inc. ME-401-003
Phase 2, Open Label, Study of ME-401 in rrFollicular Lymphoma After Failure of Two or More Prior Systemic Therapies
This is a global, multicenter, open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor ME-401 in subjects with relapsed/refractory FL. ME-401 will be administered orally at a dose of 60 mg given once a day. A cycle of treatment is 28 days in duration. Treatment with ME-401 can be administered based on a continuous schedule (CS) or an intermittent schedule (IS)

Acerta ACE-LY-003 Part 2
Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Acalabrutinib: is a potent covalent inhibitor of Btk, specifically designed to be a more potent and selective inhibitor of Btk to avoid off-target side effects as seen with ibrutinib

Incyte INCB 50465-203 CITADEL-203
A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

Acerta ACE-LY-308
Phase 3, Double-blind, Placebo-controlled, Study of BR alone vs in Combination with Acalabrutinib (ACP-196) in Subjects with Previously Untreated Mantle Cell Lymphoma (MCL)

BeiGene BGB-3111-306
Phase 3, Randomized, Open-Label, Study Comparing Zanubrutinib (BGB-3111) plus Rituximab vs Bendamustine plus Rituximab in 1st Line Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation due to age or Comorbidities

Acerta ACE-LY-106
This is a multicenter, open-label Phase 1b study to assess the safety and efficacy of acalabrutinib when administered concomitantly with BR in subjects with TN or R/R MCL (Part 1), with VR in subjects with TN MCL (Part 2)

Incyte INCB53914-102
Phase 1b Open-Label Study of the Safety and Tolerability of INCB053914 in Combination with INCB050465 in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Hutchison Medi Pharma 2018-689-00US1
Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-689 in Relapsed or Refractory Lymphoma [CLL, SLL, FL, MZL, LPL/WM, and MCL]

Previously Treated Renal Cell Carcinoma (RCC), Urothelial Carcinoma (UC), Gastric or Gastro-esophageal Junctional (GEJ) Adenocarcinoma, Colorectal Adenocarcinoma (CRC)

Pharmacyclics PYCY-1128-CA
A phase 1b/2 study of Ibrutinib combination therapy in selected advanced gastrointestinal and genitourinary tumors

Myelofibrosis (MF) and Essential Thrombocythermia (ET) (not currently enrolling)

Incyte INCB-MA-MF-401 – closed to enrollment
Prospective, longitudinal, non-interventional study of disease burden and treatment of patients with low-risk myelofibrosis (MF) or high risk essential thrombocythemia (ET) or ET patients receiving ET-directed therapy

Chronic Myelomonocytic Leukemia or MDS or AML
(not currently enrolling)

Takeda/Millenium P-3001-MLN-4924 – closed to enrollment
A phase 3, randomized, controlled, open-label, clinical study of Pevonedistat plus Azacitidine versus single-agent Azacitidine as first-line treatment for patients with higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, or low-blast acute myelogenous leukemia

Prevonedistat plus zacitidine versus single-agent Azacitidine as first-line treatment for patients with higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, or low-blast acute myelogenous leukemia

Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)

Innovent CIBI188A103
A phase 1b study evaluating the safety and efficacy of IBI188 in combination with Azacitidine in subjects with newly diagnosed higher risk Myelodysplastic Syndrome (MDS)

Breast Cancer (not currently enrolling)

Sermonix SMX 18-001 – study closed
An open-label, randomized, multicenter study evaluation the activity of Lasofoxifene relative to Fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation

Odonate ODO-TE-B301 – closed to enrollment
A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel plus a Reduced Dose of Capecitabine versus Capecitabine Alone in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated with a Taxane

AstraZeneca D5336C00001 – closed to enrollment
A Phase II, open label, randomised, multi-centre study to assess the safety and efficacy of agents targeting DNA damage repair in combination with Olaparib versus Olaparib monotherapy in the treatment of metastatic triple negative breast cancer patients stratified by alterations in homologous recombinant repair (HRR)-related genes (including BRCA1/2)

Pancreatic Cancer

IPSEN Bioscience D-US-60010-001
Phase III, open-label, randomized, study to assess efficacy and safety of the irinotecan liposome injection (Liposomal Irinotecan) +oxaliplatin+5-FU/LV combination regimen vs nabpaclitaxel+gemcitabine in patients with MPC

TN or RR Waldenstroms

Beigene 001131-216 (only cohort 2 open)
Single-Arm, Expanded Access Study of Zanubrutinib (BGB-3111) in Patients with B-cell Malignancies This is a multicenter expanded access study of zanubrutinib monotherapy for patients with B-cell malignancies who are ineligible to enroll into any available zanubrutinib clinical studies