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Changing the Paradigm
of Clinical Research

Clinical Trials

Solid Tumors

Breast Cancer

Early Stage Her 2 Neu +
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
1st Line ER/PR +/ Her2neu –/ Premenopausal LA/MBC
Novartis CLEE011E2301 MONALEESA-7
Phase III, Randomized, double-blind, placebo-controlled study of LEE011 or placebo in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin for the treatment of premenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer LEE011 is an orally bioavailable and highly selective small molecule inhibitor of the CDK4/cyclin-D1 and CDK6/ cyclin-D3 enzyme complexes
1st & 2 nd Line ER/PR +/ Her2neu –/ Postmenopausal MBC
Novartis CLEE011F2301 MONALEESA–3
Phase III, randomized double-blind, placebo-controlled study of ribociclib in combination with fulvestrant for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who have received none or only one line of prior endocrine treatment
3rd Line + Treatment of Her 2 Neu Positive MBC
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
Her 2 Neu + LA/MBC
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.
Triple-Negative, GPNMB Over-Expressing MBC
Celldex CDX011-04 'METRIC'
Phase 2, Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer, (who are taxane-resistant or intolerant and have received an anthracycline-containing chemotherapy regimen)

NSCLC

MET Altered NSCLC
Mirati Therapeutics
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.
Adjuvant NSCLC
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 GO 29527
Phase III, open-label, randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PDL1 Antibody) Compared with Best Supportive are following Adjuvant Cisplatin-based Chemotherapy in PDL-1 Selected Patients with Completely Resected Stage 1B-111A Non-Small Lung Cancer
1st Line NSCLC
Celgene ABI-007-NSCL-003 'Abound'
Phase III, Randomized, open-label, cross-over, 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
1st Line Stage IV Non-Squamous NSCLC
Genentech Roche GO 29537 'IMpower' 130
Phase III, Randomized, Open-Label Study Evaluating the Efficacy And Safety Of MPDL3280A (Anti-PD-L1 Antibody) in Combination With Carboplatin + Nab-Paclitaxel in 1st Line Stage IV Non-Squamous NSCLC
1st Line Stage IV Squamous NSCL
Genentech Roche G0 29437 'IMpower' 131
Phase III, Randomized, Open-Label, 3 Arm Study Evaluating the Efficacy And Safety of MPDL3280A (Anti-PD-L1 Antibody) in Combination With Carboplatin + Paclitaxel or MPDL3280A in Combination with Carboplatin + Nab-Pacilitaxel vs Carboplatin + Paclitaxel in 1st Line Stage IV Squamous NSCL  -  MPDL3280A is a "checkpoint inhibitor" that targets human programmed death−ligand 1 (PD-L1) and inhibits its interaction with its receptors, programmed death−1 (PD-1) and B7.1 (CD80, B7-1). Both of these interactions are reported to provide inhibitory signals to T cells. MPDL3280A is administered IV

Pancreatic

Locally Advanced Pancreatic Cancer
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)

Gastric 1st Line

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 Studies

Multiple Myeloma

1st Line Multiple Myeloma
Celgene Connect MM
The Multiple Myeloma Disease Registry  -  Connect® MM Registry is designed to explore the natural history and real world management of patients with newly diagnosed symptomatic MM and provide unique insights into the management of MM. It is designed to evaluate the effectiveness of common front-line treatment regimens and subsequent therapeutic strategies employed in the community and academic settings in the United States, as well as, describe Health Related Quality of Life (HRQoL) in the myeloma patient.
Amgen 20090482
Phase III Randomized, double-blind study of Denosumab Compared with Zoledronic Acid in the treatment of bone disease in subjects with newly diagnosed Multiple Myelom
2nd - 4th Line Multiple Myeloma
Onyx CFZ013
Phase 1b study of carfilzomib administered once weekly in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma The dose evaluation portion of the study as well as the dose expansion portion will include subjects with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy. Subjects with newly diagnosed, transplant-eligible or transplant-ineligible multiple myeloma will be enrolled only in the dose expansion portion of the study.
Multiple Myeloma Maintenance Therapy
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 STUDY POPULATION: Adult patients aged 18 years or older with a confirmed diagnosis of symptomatic NDMM who have been treated to best response with initial MM therapy for 6 to 12 months and who have achieved a major response (CR, VGPR, or PR) while receiving that regimen will be eligible for this study. These patients will not have undergone SCT, and the reasons will be thoroughly documented. The initial therapy permitted is any standard of care MM therapy. -  Ixazomib: is an oral proteasome inhibitor
1st-4th Line Multiple Myeloma
Novartis Protocol CLBH589D2222
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.

Marginal Zone Lymphoma

2nd Line + Marginal Zone Lymphoma
Pharmacyclics PCYC-1121-CA
Phase 2, Open-Label study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Relapsed/Refractory Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma (DLBCL)

Karyopharm Therapeutics, Inc. KCP-330-009
SADAL: Selinexor and Dexamethasone in Aggressive Lymphoma Phase 2b, Open-label, Two-arm Study of Selinexor (KPT-330) with Low Dose Dexamethasone in Relapsed/Refractory DLBCL Molecular Pre-screening: The DLBCL histology and subtype of each patient must be determined prior to the start of additional screening assessments to determine GCB and non-GCB subtypes

Relapsed or Refractory Hematologic Malignancies

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

Untreated Chronic Lymphocytic Leukemia

Acerta Pharma, BV ACE-CL-007
Phase 3, Open-Label, 3 Arm, Study of Obinutuzumab in combination with Chlorambucil (LEUKERAN®), ACP-196 Monotherapy in the 1st Line treatment of Chronic Lymphocytic Leukemia

2nd Line+ Chronic Lymphocytic Leukemia

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. Commercially available ibrutinib (IMBRUVICA®) will be used as the reference therapy.

B Cell Malignancies

Acerta ACE-LY-003
Phase 1B, Open-label, study of ACP-196 alone or in combination with Rituximab in Subjects with Follicular Lymphoma. ACP-196: 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.
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

2nd Line Relapsed/Refractory CLL and Intolerant of Ibrutinib

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