Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

NCI Launches Trial to Assess the Utility of Genetic Sequencing to Improve Patient Outcomes

Published: Saturday, February 01, 2014
Last Updated: Saturday, February 01, 2014
Bookmark and Share
Trial could identify patient sub-groups that are likely to benefit from certain treatments.

A pilot trial to assess whether assigning treatment based on specific gene mutations can provide benefit to patients with metastatic solid tumors is being launched this month by the National Cancer Institute (NCI), part of the National Institutes of Health.

The Molecular Profiling based Assignment of Cancer Therapeutics, or M-PACT, trial is one of the first to use a randomized trial design to assess if assigning treatment based on genetic screening can improve the rate and duration of response in patients with advanced solid tumors. A trial in which patients are randomly assigned to various treatment options is the gold-standard method for determining which treatment option is best.

Researchers hope that in addition to the knowledge gained from the trial about assigning therapy based on results of genetic sequencing of tumors, this trial could identify patient sub-groups that are likely to benefit from certain treatments and result in new treatments being developed quickly for some cancers. This could ultimately lead to smaller, more definitive clinical trials, which would be helpful to clinicians and patients in terms of cost and time.

“Patients will have their tumors genetically screened and if a pre-defined mutation is found, they will receive treatment with targeted agents,” said Shivaani Kummar, M.D., head of NCI’s Developmental Therapeutics Clinic and the principal investigator of the trial. “What we don’t know, however, is whether using this approach to assign targeted treatments is really effective at providing clinical benefit to patients, as most tumors have multiple mutations and it’s not always clear which mutation to target and which agent is most likely to provide maximal benefit. This study hopes to address some of these questions in the context of a prospective, randomized trial.”

Very few types of tumors have just one mutated gene that triggers cancer progression. Once a gene is mutated, it can lead to the activation of multiple pathways, resulting in disease progression and potentially requiring multiple interventions. Therefore, NCI’s M-PACT trial is designed to determine whether people with specific mutations that have been demonstrated in laboratory systems to affect drug effectiveness will benefit from a specifically chosen targeted intervention and if these interventions lead to better outcomes.

For NCI’s M-PACT study, after screening hundreds of people, 180 patients with advanced refractory solid tumors (those resistant to standard therapy) will be enrolled based on their genetic profile. During the screening process, samples of the tumors will be genetically sequenced to look for a total of 391 different mutations in 20 genes that are known to affect the utility of targeted therapies. If mutations of interest are detected, using a molecular sequencing protocol for tumor biopsy samples evaluated by the U.S. Food and Drug Administration, those patients will be enrolled in the trial and randomly assigned to one of two treatment arms to receive one of the four treatment regimens that are part of this study.

To ensure that patients receive the best treatment already known to provide benefit, patients with specific tumor types should have received certain therapies prior to being enrolled in NCI’s M-PACT. For instance:

• Patients with melanoma whose tumors have mutations in the V600E region of the BRAF gene should have received and progressed on a specific BRAF inhibitor therapy to be eligible for NCI’s M-PACT trial.
• Patients with lung cancer should have had their tumors tested for the presence of EGFR and ALK gene mutations, and, if mutations were detected, they should have received and progressed on therapies targeting EGFR or ALK, respectively.

Patients with all types of solid tumors will be considered for trial eligibility. For the randomization, patients will be assigned to Arm A (they will receive a treatment regimen prospectively identified to target their specific mutation or relevant pathway) or Arm B (they will receive a treatment regimen not prospectively identified to target their specific mutation or relevant pathway).

Patients in Arm B will have the option to cross over to Arm A to receive therapy identified to target their specific mutation or relevant pathway if their disease progresses on their initial study treatment. As of January 2014, the study is open for patient accrual. Clinicians hope that they can rapidly enroll patients and report results of their findings by 2017.

“We believe that this study will aid patients in the trial that will be conducted initially at the NCI, and subsequently expanded to clinical trials sites participating in the NCI-supported Early Therapeutics Clinical Trials Network,” said James Doroshow, M.D., NCI deputy director for clinical and translational research. “We also believe that M-PACT can be a model for trials nationwide, particularly those that employ genetically-driven treatment selection approaches in their design.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Study to Assess Shorter-Duration Antibiotics in Children
Physicians plan a clinical trial to evaluate whether short course anti-biotics are effective at treating CAP in children.
Wednesday, November 30, 2016
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Wednesday, November 30, 2016
Testing Zika Vaccine in Humans Begins
The first of five planned clinical trials to test ZPIV vaccine in humans has begun.
Tuesday, November 08, 2016
Skin Patch to Treat Peanut Allergy
NIH-funded study suggests peanut protein patch is a safe and convenient method of treatment.
Thursday, October 27, 2016
NIH Contributes to Global Effort to Prevent and Manage Lung Diseases
The large scale trial will measure health benefits of clean cookstoves.
Thursday, October 20, 2016
Scientists at NIH and Emory Achieve Sustained SIV Remission in Monkeys
The finding suggest that the immune systems of these animals are controlling SIV replication in the absence of antiretroviral therapy.
Friday, October 14, 2016
Drug to Treat Alcohol Use Disorder Shows Promise Among Drinkers With High Stress
The findings suggest that potential future studies with drugs targeting vasopressin blockade should focus on populations of people with AUD who also report high levels of stress.
Friday, September 30, 2016
Stem Cell Therapy Heals Injured Mouse Brain
A team of researchers has developed a therapeutic technique that dramatically increases the production of nerve cells in mice with stroke-induced brain damage.
Tuesday, August 23, 2016
Zika Vaccine Testing in Humans
The NAAID has initiated a clinical trail of a vaccine candidate for the prevention of the Zika virus infection.
Thursday, August 04, 2016
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Thursday, July 28, 2016
NIH-Funded Center to Study Inefficiencies in Clinical Trials
Researchers at the Duke Clinical Research Institute (DCRI) and Vanderbilt University Medical Center (VUMC) have received a major federal grant to study how multisite clinical trials of new drugs and therapies in children and adults can be conducted more rapidly and efficiently.
Thursday, July 07, 2016
PREVAIL Treatment Trial for Men with Persistent Ebola Viral RNA
The six-month study will enroll 60 to 120 EVD survivors.
Wednesday, July 06, 2016
Investigational Malaria Vaccine Protects Healthy U.S. Adults
Researchers at NIH have found that the malaria vaccine protected a small number of healthy, malaria-naïve adults in the U.S. from infection for more than one year after immunization.
Tuesday, May 10, 2016
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
Wednesday, April 20, 2016
Submissions Open for the Cancer Moonshot Program
NCI opens online platform to submit ideas about research for Cancer Moonshot.
Tuesday, April 19, 2016
Scientific News
BioCision Forms MedCision
The new company will focus on technologies for the management and automation of vital clinical processes.
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Study to Assess Shorter-Duration Antibiotics in Children
Physicians plan a clinical trial to evaluate whether short course anti-biotics are effective at treating CAP in children.
Cancer Gene Predicts Treatment Response in Leukaemia
Study indicates the patients suffering from a lethal for of acute myeloid leukemia may live longer when receiving milder chemotherapy drugs.
Injectable Biologic Therapy Reduces Triglycerides
Study finds first-of-its-kind therapy promising for patients with high triglycerides, cholesterol.
Testing Zika Vaccine in Humans Begins
The first of five planned clinical trials to test ZPIV vaccine in humans has begun.
Combination Therapy Improved Chemoresistance in Ovarian Cancer
The study demonstrates how an existing class of targeted therapies could be used to potentiate the tumor suppression induced by cisplatin.
Gene Therapy for Blistering Skin Disease Shows Promise
Grafting genetically altered skin onto patients’ chronic wounds marks the first time skin-based gene therapy has been demonstrated to be safe and effective in humans.
Alzheimer’s Treatment Moves a Step Closer
Merck scientists have reported the discovery of verubecestat, a structurally unique, orally bioavailable small molecule that has been shown to target the most visible sign of the disease in the brain.
Lynparza Phase III Progression-Free Survival Benefit
AstraZeneca announces results from Phase III SOLO-2 trial designed to determine the efficacy of Lynparza as a monotherapy for ovarian cancer.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!