Currently Opened Clinical Trials at The Oncology Institute

Aug. 6, 2015 - PRLog -- AML

Celgene CC-486-AML-001 (ICRI):  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.

BREAST

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

PUMA-NER-1301A (ICRI):   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 (ICRI):  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 (ICRI):  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

Astrazeneca D0819C00003 (ICRI):  A Phase III, Open Label, Randomized, Controlled, Multi-center Study to assess the efficacy and safety of Olaparib monotherapy versus Physician's Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients with germline BRCA 1/2 Mutation

Puma NER-6201 (ICRI):  A Phase II, An 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.

CLL

Gilead GS-US-312-0133 (ICRI):  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.

Gilead 325-1348 (ICRI):  A Phase 1b Dose-escalation Study Evaluating the Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of GS-9901 in Subjects with Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma.

Gilead 312-0118 (ICRI): A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Obinutuzumab Compared to Chlorambucil in Combination with Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

CML

BMS CA 180-399 (ICRI):  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

COLORECTAL

Biothera  PGG-CRC1031(ICRI): 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

HEAD and NECK

Astrazeneca D4193C00001(ICRI):  A multi-center, single-arm, global, Phase II study to determine the efficacy and safety of MEDI4736 monotherapy in the treatment of patients with recurrent or metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after treatment with a platinum-containing regimen for recurrent or metastatic disease.

Astrazeneca D4193C00003 (ICRI):  A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination with Tremelimumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Astrazeneca D4193C00002 (ICRI): A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in combination with Tremelimumab vs Standard of Care Therapy in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck.

HEMATOLOGY

Gilead GS-US-354-0101 (ICRI):  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 (ICRI):  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

Incyte INCB-MA-PV-40 (ICRI):  A Prospective, non-interventional study of disease progression and treatment of patients with Polycythemia Vera in the United States academic or community clinical practices.

HEPATOCELLULAR CARCINOMA

Merck EMR 200095-005 (ICRI):  A Multicenter, Single Arm, Phase Ib/II Study to Evaluate Efficacy, Safety, and PK of MSC2156119J as Monotherapy in Subjects with MET+ Advanced Hepatocellular Carcinoma with Child Pugh Class A Liver Function Who Have Failed Sorafenib Treatment.

LUNG CANCER

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

Eisai E7080-G000-209 (ICRI):  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.

Gilead GS-US-370-1298 (ICRI):  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 (NSCLC)

Clovis 1686-022 (ICRI):  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 (NSCLC)

Abbvie M14-359 (ICRI):  A Randomized, Open-Label, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

Genentech ML29453 (ICRI):  An Open-Label, Multicenter, Single-Arm, Expanded Access Study of Alectinib for Patients with Anaplastic Lymphoma Kinase Rearranged Non Small Cell Lung Cancer Previously Treated with Crizotinib.

Incyte INCB-18424-266 (ICRI): A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous Non-Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent.

Clovis CO-1686-020 (ICRI): A Phase 3, Open-label, Multicenter, Randomized Study of Oral Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients with Mutant EGFR Non-small Cell Lung Cancer (NSCLC) after Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy