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Clinical Trials Monthly - November 2011

Dear Colleague,

Each month Clinical Trials Monthly presents new and important trials your patients may benefit from. This month we’ve included Phase I, Phase II, and Phase III trials for breast cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and other blood cancers. Each study summary has a link to the specific details about the trial in our online Clinical Trials Database. The complete list of all trials recruiting participants at Seattle Cancer Care Alliance can be found at www.seattlecca.org/clinicaltrials.

THIS MONTH’S FEATURED CLINICAL STUDIES

Breast Cancer

A Study of Trastuzumab-DM1 [T-DM1] Plus Pertuzumab Versus Trastuzumab [Herceptin] Plus Taxane in Patients with Metastatic Breast Cancer (UW10020; NCT01120184)

This randomized, three-arm, multi-center study will evaluate the efficacy and safety of trastuzumab-DM1 (T-DM1) with pertuzumab or T-DM1 with pertuzumab-placebo, versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in patients with HER2-positive progressive, or recurrent locally advanced, or previously untreated metastatic breast cancer. Patients will be randomized to one of three treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded. This study is commonly known as the MARIANNE study.

T-DM1 was approved by the FDA in 2010 for treatment of advanced HER2-positive breast cancer in women who previously received multiple HER2-targeted medicines and chemotherapies. T-DM1 is an antibody drug conjugate (an armed antibody) being studied for advanced HER2-positive breast cancer. It attaches trastuzumab and the chemotherapy DM1 together until it reaches cancer cells. The antibody attaches onto the HER-2 positive cancer cells and is thought to disrupt its growth signals while also calling the body’s immune system to attack the cells. As the T-DM1 is absorbed into the cancer cells, the DM1 is released and destroys the cells as well.

In this study, patients can expect a three-week (21 day) treatment cycle, which applies to all study treatment arms: T-DM1 will be administered every three weeks.

  • Pertuzumab/pertuzumab-placebo will always be administered before the T-DM1 every three weeks.
  • When combined with docetaxel, a dose of trastuzumab will be administered every three weeks.
  • When combined with paclitaxel, a dose of trastuzumab will be administered weekly.

In this case a treatment cycle is three weekly doses of trastuzumab and paclitaxel. If at any stage the patient’s disease worsens, he/she will be taken off the study treatment and may receive alternative therapy. Patients will be asked to take the study drugs until the study doctor has determined that the disease has progressed, unless there are serious side effects during the study. After patients are finished taking the study drugs, patients will be asked to visit the offi ce for follow-up examinations.

Investigator: Julie Gralow, MD

Pancreas Cancer

PEGPH20 for Stage IV Previously Untreated Pancreatic Cancer (NCT01453153)

This is a Phase IB/II multi-center, international, randomized, double blind, placebo-controlled study of gemcitabine combined with PEGPH20 compared to gemcitabine combined with placebo in patients with stage IV previously untreated pancreas cancer.

PEGPH20 is a PEGylated version of human recombinant PH20 hyaluronidase that, in preclinical studies, has been shown to degrade and remove hyaluronic acid (HA) or hyaluronan from the extracellular matrix surrounding the tumor cells.  Approximately 90 percent of pancreatic ductal adenocarcinomas (PDA) overexpress HA which appears to limit the ability of drugs to penetrate the tumor. Thus, PDAs may be especially sensitive to the HA degradation and thereby become more responsive to the cytotoxic effects of a given dose of gemcitabine. Modifying the extracellular environment with a systemically deliverable enzyme to increase the penetration and effi cacy of anti-cancer agents represents a completely novel approach to treating pancreatic cancer and may provide important therapeutic outcomes in patients with this challenging disease.

The Phase IB study will assess safety, tolerability, treatment effect, and various PK/PD endpoints of PEGPH20 when used in combination with the standard-of-care, gemcitabine. Patients will receive four mg of dexamethasone (steroid given to help minimize or prevent muscle and/or joint pain that may be caused by PEGPH20) approximately one hour before treatment with PEGPH20. In the Phase II study, patients will receive four mg of dexamethasone approximately one hour before treatment with PEGPH20 or placebo and again eight to 12 hours later.

Patients will be treated on the same schedule as is used for standard gemcitabine alone. The fi rst treatment cycle consists of eight weeks (study drug treatments for the fi rst seven weeks, and one week without treatment). Each additional cycle will consist of four weeks (three weeks of study drug treatment, followed by one week without treatment). For the fi rst treatment cycle (8 weeks) patient will return to SCCA or University of Washington Medical Center twice a week for the first four weeks and then once per week for all additional weeks (total of 12 visits).

Investigators: Sunil R. Hingorani, MD, PhD; William P. Harris, MD

Hematological Malignancies

PF-05082566 for Advanced Cancer or B-Cell Lymphoma (NCT01307267)

This is a Phase I study of PF-05082566 as a single agent in patients with advanced cancer and in combination with rituximab in patients with non-Hodgkin’s lymphoma. One goal of the study is to find the best dose of PF-05082566 for treating solid tumors and B-cell lymphoma. A second goal is to fi nd the best dose of PF-05082566 together with rituximab for treating non-Hodgkin’s lymphoma.

PF-05082566 is a new investigational drug. An investigational drug is one that is not approved by the U.S. Food and Drug Administration. PF-05082566 is an antibody, which is a type of protein, shown in animal studies to stimulate the immune system. PF-05082566 is in a very early stage of development for use in humans. Patients who appear to benefi t from the drug can expect to be in this study for approximately six to 10 months. There will be a 28-day screening period, four cycles (each cycle is 28 days) of treatment, and a follow-up visit. Additional cycles of treatment may be given if determined to be of benefi t, for up to eight cycles total.

Investigator: Ajay Gopal, MD

PARP Inhibitor BMN 673 for Advanced Hematological Malignancies (NCT01399840)

This is a Phase I, two-arm, open-label study to test the safety of a new experimental drug called BMN 673, and to see what effects it has on patients and one of the four types of hematological malignancies: acute myeloid leukemia, myelodysplastic syndrome, chronic lymphocytic leukemia, and mantle cell lymphoma. BMN 673 has not been approved by the U.S. Food and Drug Administration for people with cancer. BMN 673 will not be approved unless clinical research studies show that it is safe and effective. BMN 673 is in a very early stage of development for use in humans. This drug is being developed to inhibit the normal activity of a protein called “poly (ADP-ribose) polymerase” also called “PARP.” PARP is a DNA repair enzyme. It repairs DNA that is damaged in normal and cancer cells.

Patients will be assigned to a dose level of BMN 673; this level is dependent on how many dose levels have been tested in this clinical trial before each patient is enrolled. Once it is understood what the highest tolerated dose is, additional subjects will be assigned to that dose. SCCA plans to enroll 25 subjects into this study.

Investigator: Ajay Gopal, MD

Referral or Consultation

To discuss your patients’ treatment options with an SCCA physician, please call our intake office at (206) 288-SCCA (7222) or (800) 804-8824. To read the full description of each trial or enroll your patients online, please visit www.seattlecca.org/clinicaltrials.


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