Brick Office: 732-840-8880

Toms River Office: 732-244-1440

NJHOA welcomes Drs. Randi Katz and Raghu Kunamneni to the practice.

Clinical Trials

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

Updated June 2017

Acute Myeloid Leukemia (AML)

Bio Path Protocol 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 Lymphocytic Leukemia (CLL)

Acerta Pharma, BV ACE-CL- 006
Phase 3A, Open-Label, Non-Inferiority, Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia

ACERTA Protocol ACE-CL- 309
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or
Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic
Lymphocytic Leukemia

Acerta ACE-CL- 208
Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with
Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
Spots only available for CLL with prior BTK or Idealisib Tx

Gilead GS-US- 339-0102
Phase II, Open-Label Study of GS-9973 (Entospletinib) in Subjects with
Relapsed or Refractory Hematologic Malignancies

Breast Cancer

Takeda/Millennium Protocol Number: 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 Protocol 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

Spectrum Protocol Number: SPI-GCF- 301:
Randomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of
Chemotherapy Induced Neutropenia in Breast Cancer Patients Receiving
Docetaxel and Cyclophosphamide (TC) (ADVANCE)

Novartis CLEE011A2404 COMPLEEMENT-1
Phase IIIb, Open-label, Study to Assess the Safety and Efficacy of Ribociclib
(LEE011) in Combination with Letrozole for the Treatment of Men and
Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-
negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal
Therapy for Advanced Disease

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

Celldex CDX011-04
Phase 2, Randomized (2:1) Multicenter Pivotal, open-label, Study of CDX-011
(CR011-vcMMAE) vs capecitabine in the treatment of GPNMB Over-
Expressing, Triple-Negative Metastatic Breast Cancer

Puma Therapeutics NER-1301 NALA
Phase III, Open label, study of neratinib plus capecitabine versus lapatinib
plus capecitabine in patients with HER2+ metastatic breast cancer who have
received two or more prior HER2-Directed regimens in the metastatic setting

Merrimack MM-302- 02-02- 03 Hermione
Phase 2 Open-Label trial comparing MM-302 plus trastuzumab vs. Chemotherapy
of Physicians Choice (CPC) plus trastuzumab in anthracycline naive HER2+
MBC/ LABC patients who have previously been exposed to trastuzumab,
pertuzumab and ado-trastuzumab emtansine.

Gastric Cancer

MERCK EMR100070-007 JAVELIN Gastric 100
Phase 3, Open-label, trial of maintenance therapy with avelumab (MSB0010718C)
vs continuation of first-line chemotherapy in subjects with unresectable, locally
advanced or metastatic, adenocarcinoma of the stomach, or of the gastro-
esophageal junction.

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.

Acerta ACE-LY- 106
Phase 1b, Open-label Study of ACP-196 in Combination with Bendamustine and
Rituximab (BR) in Subjects with Mantle Cell Lymphoma

B-Cell Lymphoma

Incyte – INCB 50465-202
Phase 2, Open-Label, Safety and Efficacy Study of INCB050465 in Relapsed or
Refractory Diffuse Large B-Cell Lymphoma

Lung Cancer

Merrimack SHERLOC Protocol 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 Protocol 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

Halozyme, Inc. Protocol HALO-107- 101: A Phase 1b Open-Label Study of
PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined with
Pembrolizumab in Subjects with Selected Hyaluronan-High Solid Tumors

Genentech Roche GO 29527 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

Genentech Roche G0 29437 IMpower 131
Phase III, Randomized, Open-Label, 3 Arm Study Evaluating the Efficacy And
Safety of Atezolizumab (Anti-PD- L1 Antibody) in Combination With Carboplatin
+ Paclitaxel or Atezolizumab in Combination with Carboplatin + Nab-Pacilitaxel
vs Carboplatin + Paclitaxel in 1st Line Stage IV Squamous NSCL

Genentech Roche GO 29537 IMpower 130
Phase III, Randomized, Open-Label Study Evaluating the Efficacy And Safety of
Atezolizumab (Anti-PD- L1 Antibody) in combination with Carboplatin + Nab-
Paclitaxel vs Carboplatin +Nab-Paclitaxel in the treatment of 1st Line Stage IV
Non-Squamous NSCLC

Celgene ABI-007- NSCL-003 Abound
Phase III, Randomized, Open-label, multi-center, study to evaluate safety and
efficacy of nab-paclitaxel (Abraxane) as maintenance treatment after induction
with nab-paclitaxel plus carboplatin in subjects with squamous cell NSCLC
Abraxane will be supplied by sponsor in the maintenance phase only
Abraxane and carboplatin for induction will be commercially obtained

*Celgene ABI-007- NSCLC-005 Abound 70+
Phase IV, open-label, randomized study of the Safety and efficacy of nab-
paclitaxel (Abraxane) in combination with carboplatin as 1st Line Tx in elderly
subjects with advanced NSCLC

Mirati Therapeutics 265-109 Phase 2:
Parallel-Arm, Study of MGCD265 in Patients with Locally Advanced or
Metastatic Non-Small Lung Cancer with Activating Genetic Alterations in
Mesenchymal-Epithelial Transition (MET) Factor MGCD265 is a tyrosine kinase
inhibitor that selectively targets MET and Axl MGCD265 study drug will be
administered orally twice daily (BID) in 21-day cycles.

Biodesix, Inc. BDX-00146
An Observational Study Assessing the Clinical Effectiveness of VeriStrat® and
Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer.

AstraZeneca D8488C00001 Phase IIb:
single arm, open-label, 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

Multiple Myeloma

Millenium 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 Protocol CLBH589D2222 PANORAMA
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

Merck MK-3475- 185-00 KEYNOTE 023
Phase I open-label, Multi-Cohort Trial of Pembrolizumab (MK-3475) in
Combination with Backbone Treatments (lenalidomide and low-dose
dexamethasone or with carfilzomib and low-dose dexamethasone) for relapsed or
refractory Multiple Myeloma (rMM).

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

Celgene Corporation ABI-007- PANC-007 LAPACT
Phase II, An open-label, study of nab®1-paclitaxel (Abraxane®) plus gemcitabine
in subjects with locally advanced pancreatic cancer (LAPC)

Prostate Cancer

Sotio Viable Protocol No. 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