Tag Archives: clinical trials

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TGen-TD2-Scottsdale Healthcare study benefits patients

The Side-Out Foundation’s breast cancer pilot study, led by the Translational Genomics Research Institute (TGen), Translational Drug Development (TD2) and Scottsdale Healthcare, has shown that cancer patients do better when their treatment is guided by molecular profiling.

Specifically, 52 percent of patients with advanced breast cancer received clinical benefit – meaning their disease was controlled for a longer time – when their cancer was treated based on addressing the abnormal proteins in their tumor, according to the study conducted at the Virginia G. Piper Cancer Center Clinical Trials, a partnership of Scottsdale Healthcare and TGen.

Each patient’s treatment was “personalized,” meaning that the therapy they received was based on their individual tumor biology.

“This study demonstrates the feasibility of personalized cancer treatment, and shows that this approach merits further investigation in future studies,” said Gayle Jameson, Nurse Practitioner at Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and the study’s Principal Investigator.

“The success of this pilot study will lead to a larger study and hopefully greater clinical benefit for more patients with advanced breast cancer,” said Jameson, who presented the results of the study in June at the 2013 American Society of Clinical Oncology (ASCO) in Chicago.

Due to the overwhelmingly positive results, a new study incorporating additional technology for tumor analysis, Side-Out II, will open at the Virginia G. Piper Cancer Center Clinical Trials in the near future for patients with advanced breast cancer.

“The success of our pilot proof-of-concept study has established a firm launching pad for the upcoming Side-Out II study, which involves a more in-depth investigation of tumor biology with an expanded repertoire of tests to direct personalized treatment,” said Dr. Jasgit Sachdev, M.D., a breast cancer specialist and Associate Professor at the Virginia G. Piper Cancer Center Clinical Trials.

“By showing the significant advantages of molecular profiling, this pilot study has enabled us to move forward with a project that should strengthen the evidence for using this approach in routine clinical care.”

The recent pilot study built on previous studies by Scottsdale Healthcare and TGen that showed the value of guiding treatment based on molecular profiling, in which each patient’s tumor was analyzed for protein abnormalities that may “drive” the cancer’s growth. The results pointed investigators toward specific genetic changes that might be addressed by specific medications.

Beyond molecular profiling, the pilot study also included mapping proteomic pathways within the tumor tissue so each patient could receive a highly targeted regimen designed to impede their cancer growth.

All of the patients in the recent study had advanced breast cancer that had progressed following multiple previous chemotherapy treatments. Of the 25 patients, 13 received clinical benefit as a result of molecular profiling. For all 25 patients, the therapy selected based on their tumor analysis was different than what they would have received in their next planned treatment, if they had not participated in the study.

The Virginia G. Piper Cancer Center at Scottsdale Healthcare was the lead site in the 2-½ year pilot study. In addition, patients in the study were treated at Virginia Cancer Specialists, US Oncology, in Fairfax, Vir.; and at Evergreen Hematology & Oncology in Spokane, Wash.

Translational Drug Development (TD2), a TGen company, managed the pilot clinical trial, and will also oversee the follow-on study, Side-Out II.

“This was an exciting study for TD2,” said Linda Vocila, BSN, RN, Director of Clinical Operations at TD2 and co-author of the study. “It demonstrates that close collaboration between physicians and scientists leads to greater clinical benefit for patients with cancer.”

Two labs analyzed tissue: the Center for Applied Proteomics and Molecular Medicine (CAPMM) at George Mason University in Manassas, Vir.; and Caris Life Sciences in Phoenix.

The Side-Out Foundation of Fairfax, Vir., sponsored the study.

To participate in a clinical trial at the Virginia G. Piper Cancer Center, please contact Patient Care Coordinator Joyce Schaffer at 480-323-1339 or joschaffer@shc.org.

medical.research

FDA approved thyroid cancer drug tested by TGen

The FDA has approved a thyroid cancer drug successfully tested at Virginia G. Piper Cancer Center Clinical Trials, a partnership of Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

The U.S. Food and Drug Administration approved cabozantinib for the treatment of progressive, metastatic medullary thyroid cancer (MTC), a rare endocrine gland cancer affecting the thyroid. Previously, MTC patients had limited treatment options.

“This was a really exciting trial. We have a drug that blocks the gene that causes a rare type of cancer,” said Dr. Michael Demeure, the Site Principal Investigator on the Phase III clinical trial and endocrine surgeon at Scottsdale Healthcare. “We’re trying to do more tests like this to try to bring innovative and exciting new cancer drugs for our patients.”

More than 56,000 Americans will be diagnosed with thyroid cancer this year, and 1,780 will die from the disease. About 4 percent of thyroid cancers are medullary, a form of carcinoma that originates from the parafollicular, or C, cells, which produce the hormone calcitonin. Physicians are able to confirm a diagnosis of MTC by detecting elevated levels of calcitonin in the blood.

MTC often is not detected until its late stages. And unlike 90 percent of differentiated thyroid cancers, MTC does not respond to the most common treatments, making it difficult to manage.

The RET gene, which is part of the family of tyrosine kinase proteins, plays a role in the development of MTC. Cabozantinib is an inhibitor of multiple receptor tyrosine kinases, including RET, MET and VEGFR2.

“Cabozantinib targets tyrosine kinases that are important in medullary thyroid cancer, including RET, MET and VEGFR2. When such tyrosine kinases — which are known to play a role in tumor growth and metastasis — are also the drug target, that gives you hope that you can impact favorably on the disease,” said Dr. Demeure, contrasting MTC with other cancers, such as pancreatic cancer, where the precise genetic source of the cancer remains unconfirmed or unknown.

The Virginia G. Piper Cancer Center at Scottsdale Healthcare enrolled two patients with MTC as part of an international randomized clinical trial of more than 300 patients.

FDA’s approval on Nov. 29 was based on demonstrating improved progression-free survival (PFS). The estimated median PFS was 11.2 months for patients taking cabozantinib, compared to 4 months for patients taking placebo. The drug is sold as COMETRIQ and marketed by South San Francisco-based Exelixis, Inc.

One patient who continues to benefit from clinical trial treatments at Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials is Gordon Hunt, 68, a retired life-insurance salesman from Phoenix.

Hunt said he started noticing discomfort in his neck several years ago. After seeing a series of specialists, a calcitonin test finally confirmed that he had an advanced case of MTC.

Hunt endured several surgeries that included the removal of his thyroid and lymph nodes in his neck and chest. Following his most recent surgeries more than two years ago, performed by Dr. Demeure, Hunt’s calcitonin levels dropped from a one-time high of 3,300 picograms per milliliter, when he was first diagnosed, to about 500 pg/ml.

After receiving cabozantinib since February 2011, Hunt’s calcitonin levels are down to about 250 pg/ml, indicating that the cancer might still be in his system, but he has had no detectable tumors.

“I feel like he saved my life,” Hunt said of Dr. Demeure, who suggested he take part in the cabozantinib clinical trial.

“I’m just thankful for it, because I’m sure I’d be probably ready for another surgery of some sort if I hadn’t been on the medication,” said Hunt, who also expressed gratitude to the entire staff of the Virginia G. Piper Cancer Center at Scottsdale Healthcare. “They’ve been responsive to my every need.”

Hunt said he at first suffered side effects, including vomiting, diarrhea, stomach pains, weight loss and constipation. But by lowering his dosage, the side effects eventually diminished, he said. Dose reduction was required in 79 percent of clinical trial patients, according to the FDA.

Hunt receives monthly doses of the drug along with tests for calcitonin, as well as quarterly scans for tumors.

Between doses, he and his wife Nancy, a retired schoolteacher, travel extensively, including trips in the past year to California, Texas, Missouri and Australia.

“We’re still active, so that’s a good thing,” said Hunt, noting that the couple, who have lived 47 years in Phoenix, still go regularly to the gym and are active in their church.

“I’m excited. I played a part in making it (FDA approval) happen,” Hunt said. “I thank God that I was chosen to take part in obtaining the approval of the medication. If it works for me, it’s going to work for other people, and that’s good.”

In addition to treating MTC, cabozantinib is being explored as a therapy for numerous tumor types, including prostate, ovarian, brain, melanoma, breast, and non-small cell lung cancers.

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CRA forms alliance with Quintiles

Tempe-based Clinical Research Advantage (CRA), the country’s largest community-based network of clinical trial sites, has entered into a strategic agreement  with Quintiles to facilitate a higher level of clinical trial participation with an emphasis on safety, improved study efficiencies and excellent quality data in medical research. Clinical Research Advantage is the first therapeutically aligned network of Family Medicine community-based sites selected by Quintiles as a strategic alliance.

“It is an honor to be chosen by Quintiles, the world’s largest biopharmaceutical services provider with the highest standards for quality and safety,” said Mark S. Hanley, CRA’s Chief Executive Officer. “The core value and principal purpose of Clinical Research Advantage is to improve the lives of patients through the development of new medical therapies. Working with Quintiles will allow CRA to conduct an increased number of community-based trials with unparalleled accuracy and safety.”

“Clinical Research Advantage impressed us with their high standards for quality, high patient enrolments, and exceptional study start-up abilities,” said Lindy Jones, Senior Vice President, Integrated Site Services, Quintiles. “Many chronic conditions such as diabetes and heart disease are now managed in the community. It is imperative that these patient populations have the opportunity to participate in studies and be a part of the quest to develop new and better medicines for conditions that have a significant impact on both individuals and society.  We are pleased to enter into this relationship with CRA and anticipate that together we will ensure that studies start on the right path.”

The CRA-Quintiles relationship marks a new era in Phase II – IV clinical trials, enabling physicians and clinical researchers to conduct an increased number of trials across a wide range of disease areas. In addition, it will streamline and expedite the process of bringing these potentially life-changing and life-saving drugs to market.
About Clinical Research Advantage

Tempe, Arizona-based Clinical Research Advantage, Inc. (CRA) is a provider of a range of research services to pharmaceutical companies and clinical research organizations. As a leading trial management organization, CRA operates from 38 sites across 17 geographic markets nationwide, helping trial sponsors bring drugs to market more quickly and efficiently. Founded in 1992, CRA has successfully completed more than 1,800 clinical trials on behalf of its clients. For more information, please visit www.crastudies.com.

medical.research

Tempe’s CRA acquires Radiant Research

Tempe-based CRA Holdings, LLC announced that it has acquired Radiant Research, Inc. CRA Holdings is the company that also owns Clinical Research Advantage (CRA), another major player in the SMO market. By combining these two entities under the same investment portfolio, the organizations collectively have 57 sites with more than 550 research professionals and an aggressive plan for growth.

Over the past 15 years, Radiant Research has focused on common and chronic conditions that can be recruited from the general population. Radiant specializes in trials that require large numbers of subjects to be recruited in a short period of time, or complex trials that require specialized equipment or procedures. Radiant has large stand-alone facilities in which it conducts research; the company recruits studies primarily from an active database of over one million volunteers. CRA, on the other hand, is a practice-based organization, where 85% or greater of trial participants are recruited from the investigator’s private practice. This has allowed CRA to focus on trials where disease-state management is required. Both organizations are leaders in vaccine trial execution. The union of these two companies provides for better access to patients, an ability to conduct a diverse array of trials and broader geographic diversity.

“The Radiant platform will facilitate faster expansion of our model by utilizing the Radiant sites to help launch practice-based satellite locations in the cities where Radiant already has sites. We have grown CRA from seven to 37 sites in the last five years. In order for us to achieve our goal of 80 or 90 sites in the manner we have been doing would take us at least another five years.  The Radiant acquisition will be the catalyst for much faster growth in the next 12 months,” said Mark Hanley, CEO of CRA.

“By combining the models under one umbrella, we will be able to conduct almost every type of trial, be it point of care or studies more appropriate for a stand-alone research facility,” said Julie McHugh, CEO of Radiant Research. “We have been looking for a partner that has a shared vision for growth without any sacrifice in quality. In CRA, we have found that partner.”

The combined companies will continue to function under the names of Radiant Research and CRA, but will be looking to integrate and streamline their operations in areas where integration makes sense.

Tempe-based CRA is a provider of a range of research services to pharmaceutical companies and clinical research organizations. As a leading trial management organization, CRA operates from 37 sites across 17 geographic markets nationwide, helping trial sponsors bring drugs to market more quickly and efficiently. Founded in 1992, CRA has successfully completed more than 1,800 clinical trials on behalf of its clients. For more information, please visit www.crastudies.com.

clinical research advantage

Clinical Research Advantage Receives 5 STEVIE Awards

Tempe-based Clinical Research Advantage, a community-based network of clinical trial sites, was honored with three Silver and two Bronze STEVIE Awards at the 10th Annual American Business Awards held on June 18th in New York City. The American Business Awards are the nation’s premier business awards program. This year, more than 3,000 nominations from organizations of all sizes and in virtually every industry were submitted for consideration in a wide range of categories.

Clinical Research Advantage received the following awards:

  • The Silver Award for Company of the Year in the Pharmaceuticals category.
  • A Bronze Award for the Fastest-Growing Company of the Year in the Pharmaceuticals category.
  • David Bruggeman, CRA’s President and Chief Operating Officer, was honored with Silver Awards for Executive of the Year in both the Pharmaceuticals and the Health Products and Services categories.
  • Casey Orvin, CRA’s Vice President of Business Development and Amanda Drake, CRA’s Director of Business Development were honored with a Bronze Award for Management Team of the Year in the Pharmaceuticals Category.

“David Bruggeman, Casey Orvin, Amanda Drake and all of CRA’s employees have made 2012 a remarkable year for our company. Each employee is dedicated to our mission of enhancing patient care by bringing drugs to market more quickly and efficiently, and I would like to congratulate them on achieving this level of recognition from the STEVIE® Awards,” said Mark S. Hanley, CRA’s Chief Executive Officer.

Clinical Research Advantage, Inc. (CRA) is a provider of a range of research services to pharmaceutical companies and clinical research organizations. As a leading trial management organization, CRA operates from 33 sites across 17 geographic markets nationwide, helping trial sponsors bring drugs to market more quickly and efficiently. Founded in 1992, CRA has successfully completed more than 1,800 clinical trials on behalf of its clients. For more information, visit www.crastudies.com.

For more information about Clinical Research Advantage, visit their website at crastudies.com