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Toms River Office: 732-244-1440

NJHOA welcomes Dr. Bartosz Walczyszyn!

Clinical Trials

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

Updated February 2018

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

Chronic Myelomonocytic Leukemia or MDS or AML

Tekada Pevondistat – 3001
Randomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of
Chemotherapy Induced Neutropenia in Breast Cancer Patients Receiving Docetaxel
and Cyclophosphamide (TC) (ADVANCE)

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

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

Breast Cancer

Takeda/Millennium C31006
An Open-Label Phase 2 Study ofMLN0128 (A TORC1/2 Inhibitor) in
Combination With Fulvestrant in Women With ER-Positive/HER2- Negative
Advanced or Metastatic Breast Cancer That Has Progressed During or After
Aromatase Inhibitor Therapy

Macrogenics Sophia CP-MGAH22- 04:
A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs
Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+
Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and
Require Systemic Treatment

PUMA-NER- 6201
Phase 3, Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive
Loperamide Prophylaxis

AstraZeneca Violette – D5336C00001
A Phase II, Open Label, Randomized 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)

Hematologic

Celgene Corporation CC-5013- NHL-008 Magnify
Phase 3b, Study of Lenalidomide Plus Rituximab Maintenance Therapy Followed by
Lenalidomide Single-Agent Maintenance Versus Rituximab Maintenance in Subjects
with Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma (MCL).

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)

B-Cell Lymphoma

Incyte – INCB 50465-102 Citadel-102
Phase 1, Open-Label, Dose-Finding, and Cohort-Expansion Study Evaluating Safety
and Efficacy of INCB050465 in Combination With Bendamustine and Obinutuzumab in
Subjects With Relapsed or Refractory Follicular Lymphoma

Incyte – INCB 50465-202 Citadel 202
Phase II, Open-Label, Safety and Efficacy Study of INCB050465 in Relapsed or
Refractory Diffuse Large B-Cell Lymphoma

Incyte INCB 50465-203 CITADEL-203
Phase II, Open-Label, Study comparing INCB050465, a PI3Kδ Inhibitor, to Idelalisib in
Relapsed or Refractory Follicular Lymphoma

Incyte – INCB 50465-204 Citadel-204
Phase II, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects
with Relapsed or Refractory Marginal Zone Lymphoma with or without Prior Exposure to
a BTK Inhibitor

Incyte – INCB 39110-206 Citadel-206
Phase 1/2 Open-Label Study of INCB039110 in Combination with Ibrutinib in Relapsed
or Refractory Diffuse Large B-Cell Lymphoma.

Essential Thrombocytopenia/Myelofibrosis

Incyte INCB-MA- MF-401
Prospective, Longitudinal Non Interventional Study of Disease Burden and Treatment of
Patients with Low Risk myelofibrosis or High Risk Essential Thromnocythemia (ET) or
ET Patients Receiving ET Directed Therapy.

Lung Cancer

Radiance – D5160L00032
An Open-label, Non-randomized, Prospective Biomarker Study to Assess Analytic
Concordance Between Non-invasive Testing and Tissue Testing for EGFR T790M
Mutation Detection in Patients with Non-Small Cell Lung Cancer

Merrimack SHERLOC MM-121- 01-02- 09
A Phase 2 Study of MM-121 in Combination with Docetaxel or Pemetrexed versus
Docetaxel or Pemetrexed Alone in Patients with Heregulin Positive, Locally Advanced
or Metastatic Non-Small Cell Lung Cancer

AstraZeneca Adaura D5164C00001
A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, study to
assess the efficacy and safety of AZD9291 versus Placebo, in Patients with Epidermal
Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung
Carcinoma, following Complete Tumor Resection With or Without Adjuvant Chemotherapy

Genentech Roche GO29527
Phase III, open-label, randomized Study to Investigate the Efficacy and Safety of
Atezolizumab (Anti-PDL1 Antibody) Compared with Best Supportive care following
Adjuvant Cisplatin-based Chemotherapy in PDL-1 Selected Patients with Completely
Resected Stage 1B-111A Non-Small Lung Cancer

Multiple Myeloma

Millennium C16021
Phase III, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance
Therapy, After Initial Therapy in Patients with Newly Diagnosed Multiple Myeloma Not
Treated With Stem Cell Transplantation

Novartis CLBH589D2222 PANORAMA 3
Phase 2, Open-Label Randomized, Study Evaluating the Safety and Efficacy of Three
Different Doses of Oral Panobinostat (Farydak®) in combination with Subcutaneous
Bortezomib and Oral Dexamethasone in Patients with Relapsed Multiple Myeloma Who
Have Been Previously Exposed to Immunomodulatory Agents.

Ovarian

AstraZeneca D8488C00001 Concerto
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 who do not carry a deleterious or suspected
deleterious germline BRCA mutation

Pancreatic

Boston Biomedical, Inc. CanStem111P
Phase III Open Label, Randomized, Study of the Cancer Stem Cell Inhibitor BBI-608
Plus Nab-Paclitaxel with Gemcitabine (Arm 1) Versus Nab-Paclitaxel with Gemcitabine
(Arm 2) in Metastatic Pancreatic Adenocarcinoma.

Prostate Cancer

Sotio Viable SP005
A Randomized, Double Blind, Multicenter, Parallel-Group, Phase III Study to Evaluate
Efficacy and Safety of DCVAC/PCa versus Placebo in Men with Metastatic Castration
Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

Multiple Cancers

MTG-022
Translational Medicine: Discovery and Evaluation of Biomarker /Pharmocogenomics for
the Diagnosis and Personalization Management of Patients