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Clinical Trials Monthly - April 2014

The knowledge we gain from clinical trials helps develop more effective, less toxic cancer treatments. Each month we publish this newsletter with our HOTLIST of the newest clinical trials that might be of interest to you and your patients.

New Trial Studies Anti-Tumor Activity of Gefitinib with Anti Pd-L1 MEDI4736 In Non-Small Cell Lung Cancers

Non-small cell lung cancer (NSCLC) is notoriously difficult to treat or cure. Resectable disease may be cured by surgery or surgery followed by chemotherapy, and radiation therapy can provide local control in unresectable disease, but few people are cured. The need for effective NSCLC treatments is great.

Seattle Cancer Care Alliance (SCCA) has an open Phase I study that will determine a safe dose of anti-PDL1 drug, MEDI4736, in combination with gefitinib to shrink tumors. This is the first time for this combination to be tested in patients. MEDI4736 is an antibody that acts on the PD-L1 ligand. It has not been approved by any authority that regulates new medicines. Gefitinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that blocks the action of EGFR, which is commonly found on the surface of cancer cells and causes tumors to grow. It has not been approved in the United States, but has been approved in other countries in Europe and Asia.

Based on results of preliminary non-clinical studies, it is assumed that MEDI4736 in combination with gefitinib treatment may have increased efficacy in patients with a variety of advanced NSCLC compared to EGFR TKI (gefitinib) monotherapy. This study will measure levels of MEDI4736 and gefitinib in the blood and determine the effect on the body including immune responses and potential adverse reactions. SCCA’s principal investigator in this trial is Laura Q.M. Chow, MD. Read more about this study.

Lung Cancer

Alisertib (MLN8237) in Combination with Paclitaxel for Small Cell Lung Cancer

A Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Trial of Alisertib (MLN8237) in Combination with Paclitaxel versus Placebo in Combination with Paclitaxel as Second-Line Therapy for Small Cell Lung Cancer (SCLC) (NCT02038647)

In this double-blind study, patients will receive alisertib (also known as MLN8237), or placebo, in combination with taxol (Paclitaxel). Alisertib, an oral tablet, is being developed as a possible treatment for small cell lung cancer as a second-line therapy in combination with Paclitaxel. This study’s purpose is to measure safety and the length of time during and after treatment that disease responds after patients are treated with alisertib in combination with Paclitaxel, or placebo in combination with Paclitaxel. Patients will give blood and a stored tumor tissue sample (if available) for the biomarker research portion of this study. Genetic testing of these samples will identify, confirm, and validate biomarkers. Researchers are looking for how differences in genetic makeup may influence the way people respond and develop side effects to MLN8237. Investigator: Christina S. Baik, MD, MPH

Lymphoma

A+AVD versus ABVD as Frontline Therapy for Hodgkin’s Lymphoma

A Randomized, Open-Label, Phase III Trial of A+AVD versus ABVD as Frontline Therapy in Patients with Advanced Classical Hodgkin’s Lymphoma (NCT01712490)

Brentuximab vedotin (Adcetris) targets CD30 on the cancer cell. The U.S. Food and Drug Administration (FDA) has approved the drug for treating some types of lymphoma when other therapies have failed. The goal of this Phase III, randomized, two-arm, multicenter study is to compare the modified progression-free survival of Adcetris when it is administered with AVD (doxorubicin, vinblastine, and dacarbazine; abbreviated A+AVD) as compared to treatment with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for frontline treatment of advanced classical Hodgkin’s lymphoma. This study will also look for differences in DNA, RNA, and proteins related to the disease and its response to the study drug. Investigator: Ajay K. Gopal, MD

Prostate Cancer

Galeterone for Castration Resistant Prostate Cancer (ARMOR2)

A Two-Part, Phase II Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer (NCT01709734)

This is a two-part trial to study an investigational new drug, galeterone. This trial will evaluate galeterone to confirm the safest dose and fi nd out how it moves through the body. Researchers hope to determine if it is effective at treating prostate cancer when other treatments have failed and gain more information about possible side effects. It has only been approved by the FDA for investigational use. Animal tests have shown that galeterone can reduce the size of prostate cancer tumors. These tests and other laboratory tests suggest that galeterone can make it harder for prostate cancer cells to make testosterone, prevent whatever testosterone is still around from attaching to the androgen receptor, and reduce the number of androgen receptors in the prostate cancer tumor. Together, these three effects may deprive prostate cancer tumor cells of what they need to grow, although whether these effects will be seen in humans is not yet known. Investigators: Bruce Montgomery, MD

Urothelial Cancer

AGS15E For Metastatic Urothelial Cancer

A Phase I Study of the Safety and Pharmacokinetics of Escalating Doses of AGS15E Given as Monotherapy in Subjects with Metastatic Urothelial Cancer (NCT01963052)

AGS15E is an investigational drug; an antibody drug conjugate (ADC) has only been approved by the FDA for investigational use. It consists of a fully human monoclonal antibody attached to a chemotherapy drug called monomethyl auristatin E (MMAE). The monoclonal antibody carries the chemotherapy drug to cancer cells that have the SLITRK6 protein (the target protein). Patients receive AGS15E as a 30-minute infusion once weekly for three weeks of a four-week cycle. This is the first study in humans of AGS15E. The side effects of this drug in humans are not known. Investigator: Evan Yu, MD

Hotlist

NCI Designation

Disease Site

Description

NCT01564784

Bladder Cancer

A Phase I Study of the Safety and Pharmacokinetics of Escalating Doses of AGS15E Given as Monotherapy in Subjects with Metastatic Urothelial Cancer

NCT01744223

Breast Cancer

Low-dose Tamoxifen for Radiation-Induced Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial

NCT01969643

Breast Cancer

Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer

NCT01196936

Breast Cancer

ACRIN 6702: A Multicenter Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer

NCT01276704

Breast Cancer

Intensive Trial of OMics in Cancer (ITOMIC) 001- Intensive Longitudinal Monitoring in Patients with Triple Negative Breast Cancer

NCT02022579

GVHD

Phase III Study of US-ATG-F to Prevent Moderate to Severe Chronic GVHD in Adult Acute Myeloid Leukemia, Acute Lymphoid Leukemia, and Myelodysplastic Syndrome Patients After Allogeneic Stem Cell Transplantation From Unrelated Donors

NCT01295710

GVHD

Phase III Randomized Observer Blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals Herpes Zoster Vaccine GSK1437173A

NCT01610414

Leukemia

An Open-Label, Randomized Phase III Study of Inotuzumab Ozogamicin Compared to a Defined Investigator's Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)

NCT01982123

Lung Cancer

Pulmonary Functional Imaging for Radiation Treatment Planning for Lung Cancer

NCT01752114

Lung Cancer

Early Diagnosis of Pulmonary Nodules Using a Plasma Proteomic Classifier

NCT01728805

Lung Cancer

A Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Trial of Alisertib (MLN8237) in Combination with Paclitaxel versus Placebo in Combination with Paclitaxel as Second-Line Therapy for Small Cell Lung Cancer (SCLC).

NCT01855750

Lung Cancer

A Randomized, Open-Label Phase II Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients with Acquired Resistance to Erlotinib

NCT01712490

Lung Cancer

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Gefitinib in Combination with MEDI4736 (Anti PD-L1) in Subjects With Non-Small Cell Lung Cancer(NSCLC)

NCT01991184

Lymphoma

Open-Label, Multicenter, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (mogamulizumab) versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma

NCT01682083

Lymphoma

A Randomized, Double-Blind, Placebo-Controlled Phase III Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

NCT01844505

Lymphoma

A Randomized, Open-Label, Phase III Trial of A+AVD versus ABVD as Frontline Therapy in Patients with Advanced Classical Hodgkin Lymphoma

NCT01881789

Lymphoma

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0853 in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

NCT01583283

Lymphoma

A Multicenter, Open-Label, Phase II Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects with Relapsed/Refractory Marginal Zone Lymphoma

NCT01894477

MDS

A Randomized Phase II Multicenter Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients with Myelodysplastic Syndrome (MDS)

NCT01772953

Melanoma

COMBI-AD: A Phase III Randomized Double-Blind Study of Dabrafenib (GSK2118436) in Combination with Trametinib (GSK1120212) versus Two Placebos in the Adjuvant Treatment of High-Risk BRAF V600 Mutation-Positive Melanoma After Surgical Resection

NCT02061761

Melanoma

A Phase III, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab versus Ipilimumab Monotherapy in Subjects with Previously Untreated Unresectable or Metastatic Melanoma

NCT01988896

Pediatric Transplants

A Phase II Study of Treosulfan/Fludarabine/Low Dose Total Body Irradiation as a Preparative Regimen for Children with AML/MDS Undergoing Allogeneic Hematopoietic Cell Transplantation

NCT01881867

Phase I - Solid Tumor

A Phase Ib Study of the Safety and Pharmacology of MPDL3280A Administered with Cobimetinib in Patients with Locally Advanced or Metastatic Solid Tumors

NCT01946204

Phase I-CLL/Lymphoma

A Phase I Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

NCT01946204

Prostate Cancer

A Phase II Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) after Completion of Standard FDA-Approved Therapy with Sipuleucel-T (Provenge) for Patients with Asymptomatic or Minimally Symptomatic Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT01946204

Prostate Cancer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer

NCT01946204

Phase I/II Transplant

A Phase I/II Dose-Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells after Partially Mismatched, Related, T Cell-Depleted HSCT



Adult Bone Marrow Transplant News

The SCCA Adult Bone Marrow Transplant News is a publication presenting the latest information on bone marrow transplant research at SCCA, providing up-to-date information for all health care professionals caring for transplant patients.

Pediatric Bone Marrow Transplant News

Read about important outcomes research at the Hutchinson Center that may benefit your patients.

Clinical Trials Monthly

Each issue of Clinical Trials Monthly highlights several of the more than 200 clinical trials that are currently recruiting patients at SCCA.

The Leading Edge Newsletter

Each quarterly Leading Edge newsletter will highlight a new topic to give you the latest news on leading-edge therapies that SCCA physicians are offering.