The Oncology Institute of Hope and Innovation Offers New Clinical Trials this Holiday Season

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The Oncology Institute of Hope and Innovation is pleased to announce the recent openings of clinical trials this holiday season.

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Below are currently opened clinical trials. If you would like more information or are interested in referring a patient to one of these trials, please contact Hilda Agajanian at (562) 869-1201.

Celgene CC-486-AML-001: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myloid Leukemia in Complete Remission.

Genentech ML 28257: An observational cohort study of treatment patterns and outcomes in patients with HER2 positive (HER2+) Metastatic Breast Cancer

PUMA-NER-1301A: 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 (NALA)

Astellas 9785-CL-1121: A Phase 2, Multicenter, open-label study to Assess the Efficacy and Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer

AbbVie M12-914: A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

Gilead GS-US-312-0123: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia

Gilead GS-US-312-0133: A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion.

BMS CA 180-399: An open label, randomized (2:1) Phase 2B study of dasatinib vs imatinib in patients with chronic phase chronic myeloid leukemia who have not achieved an optimal response to 3 months of therapy with 400 mg imatinib

Novartis CAMN107A US37: A Phase II Randomized, Multicenter Study of Treatment- Free Remission in Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Patients who Achieve and Sustain MR4.5 after Switching to Nilotinib

Pfizer B1871042: A Non-Interventional Study of Bosutinib in Patients with Previously Treated Chronic Phase Chronic Myelogenous Leukemia (CML)

Biothera PGG-CRC1031: A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination with Cetuximab (Erbitux®) in Subjects with Recurrent or Progressive KRAS Wild Type Colorectal Cancer

Gilead GS-US-354-0101: A Phase 2, Open-label, Randomized Study to Evaluate the Safety and Efficacy of Momelotinib in Subjects with Polycythemia Vera or Essential Thrombocythemia

Gilead GS-US-352-1214: A Phase 3, Randomized Study to Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects with primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis who were Treated with Ruxolitinib

Lung Cancer
Astex AT 13387-05: A Study of HSP90 Inhibitor AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer

Genentech / Roche MO22097: An Open-Label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer After First-Line Treatment with Bevacizumab Plus A Platinum Doublet-containing Chemotherapy

Eisai E7080-G000-209: A Multicenter, Open-Label Phase 2 Study of the Safety and Activity of Lenvatinib (E7080) in Subjects with KIF5B-RET-Positive Adenocarcinoma of the Lung

Clovis CO-1686-008: A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-Small Cell Lung Cancer

Gilead GS-US-370-1298: A Phase 1b Study of Erlotinib and Momelotinib for the Treatment of Epidermal growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naïve Metastatic Non-Small Cell Lung Cancer

Clovis 1686-022: A Randomized, Open-Label, Phase II Study of CO-1686 or Erlotinib as First-Line Treatment of Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer

Multiple Myeloma
BMS CA 204008 ST: Prospective Reseach Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

Onyx Protocol 2012-003: A Multicenter, Open-Label, Phase 1/2 Study of Carfilzomib, Cyclophosphamide and Dexamethasone induction Followed by Randomization to Carfilzomib Maintenance versus Observation in New Diagnosed Multiple Myeloma Subjects

Onyx Protocol 2012-005: A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone versus Bortezomib, Melphalan and Prednisone in Transplant-ineligible Patients with Newly diagnosed Multiple Myeloma

Celgene CC-4047-MM-014: A Phase 2, Multicenter, Single-Arm, Open-Label Study of Pomalidomide in Combination with Low-Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma Following Lenalidomide Plus Dexamethasone in the Second-Line Setting

Nausea and Vomitting
Accelovance APPA C2013-01: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15mg/kg IV, Fosaprepitant 150 mg IV, and Dexamethasone for the Prevention of Chemotherapy-Induced nausea and Vomiting in Subjects Receiving Highly Emetogenic Chemotherapy

Non-Hodgkins Lymphoma
BAYER 16349: Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY 80-6946 in Patients with Relapsed, Indolent or Aggressive Non-Hodgkin’s Lymphomas

Eleison EP-GF-301: A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared with Fluorouracil (5-FU) in Patients with Metastatic Pancreatic Adenocarcinoma Previously Treated with Gemcitabine

Incyte 18424-362A: Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 Inhibitor, Ruxolitinib or Placebo in Combination with Capecitabine in Subjects with Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy

Solid Tumors
Nektar NKTR-102: A phase 1 study to evaluate the effect of NKTR-102 for injection (ETITRNOTECAN PEGOL) on the QT/QTC interval in patients with advanced OR metastatic solid tumors.

Specimen Collection (Bone Marrow)
Conversant Biologics CBIO-BB011.V.1: An Observational Study to Collect Specimens for Future Scientific Research

If you have patients who you feel may qualify for this trial, or have questions regarding eligibility, please contact The Oncology Institute at (562) 869-1201. We look forward to working with you and Happy Holidays!

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Marianne Aranda
The Oncology Institute
+1 (562) 869-1201 Ext: 101
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