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

CTI Announces GOG Completes Patient Enrollment in GOG-0212

Published: Thursday, January 30, 2014
Last Updated: Thursday, January 30, 2014
Bookmark and Share
Patient enrollment in Phase 3 clinical trial of Opaxio™ as maintenance therapy in ovarian cancer.

Cell Therapeutics, Inc. (CTI) has announced that the Gynecologic Oncology Group (GOG) informed CTI that it has completed patient enrollment in the GOG-0212 Phase 3 clinical trial of investigational agent paclitaxel poliglumex (Opaxio™ ) as maintenance therapy in ovarian cancer.

"Although initial treatment is effective in putting this disease in remission, there is a high relapse rate for patients with ovarian cancer and there are limited treatment options when their cancer returns," said Larry J. Copeland, M.D., Department of Obstetrics and Gynecology, Ohio State University Comprehensive Cancer Center, Group Vice Chair of the GOG and chair of the GOG-0212 study. "This study was designed to investigate whether Opaxio when used in a maintenance setting could keep these women in remission and as a result extend the lives of these patients. We are very pleased to have completed enrollment in this important study."

"This is a significant achievement for the GOG being the largest maintenance study for patients with ovarian cancer ever conducted having enrolled 1,150 patients," said James A. Bianco, M.D., President and CEO of CTI. "There is a significant unmet need in keeping a patient's cancer from returning following initial treatment, and we are hopeful that Opaxio has the potential to serve this role in ovarian cancer."

The trial is being conducted and managed by the GOG, which is one of the National Cancer Institute's (NCI) funded cooperative cancer research groups focused on the study of gynecologic malignancies.

The GOG-0212 study is a randomized, multicenter, open label Phase 3 trial of either monthly Opaxio or paclitaxel for up to 12 consecutive months compared to surveillance among women with advanced ovarian cancer who have no evidence of disease following first-line platinum-taxane based therapy. For purposes of registration, the primary endpoint of the study is overall survival of patients treated with Opaxio compared to no maintenance therapy.

Secondary endpoints are progression-free survival, safety and quality of life. The statistical analysis plan calls for up to four interim analyses and one final analysis, each with boundaries for early closure for superior efficacy or for futility.

The first interim analysis was conducted in January 2013, which passed the futility boundary and continued with no changes. Additional information about GOG-0212 may be found at www.clinicaltrials.gov, study ID NCT00108745.


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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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

CTI Announces UK NCRI AML Cooperative Group Phase 2 Trial Evaluating Pacritinib for AML Patients
Trial sponsored by Cardiff University and supported by Cancer Research UK.
Tuesday, February 04, 2014
Cell Therapeutics Appoints Karen Ignagni to Board of Directors
Ms. Ignagni currently serves as President and Chief Executive Officer of AHIP.
Tuesday, February 04, 2014
CTI Reaches Agreement with Novartis
Agreement to reacquire rights to two anti-cancer compounds.
Monday, January 13, 2014
PIXUVRI® Receives Positive Final Appraisal Determination from NICE
PIXUVRI deemed cost effective for patients with multiply relapsed or refractory aggressive b-cell non-Hodgkin lymphoma (NHL).
Monday, January 06, 2014
CTI Announces Removal of the Partial Clinical Hold on Tosedostat
Company has received notification from the U.S. Food and Drug Administration.
Thursday, January 02, 2014
CTI and GKV-SV Reach Agreement on Pricing of PIXUVRI® (pixantrone) in Germany
Decision applies to patients with aggressive B-cell non-Hodgkin lymphoma who have failed two or three prior lines of therapy.
Wednesday, December 04, 2013
CTI Announces Data Presentations at the 55th ASH Annual Meeting
Pacritinib phase 2 analysis of myelofibrosis patients with thrombocytopenia (low platelets) accepted for oral presentation.
Monday, November 11, 2013
CTI Announces Results from Preclinical Study of PIXUVRI® Presented at the AACR-NCI-EORTC Meeting
Findings suggest new class of anti-cancer agents with novel mechanism for tumor cell killing.
Monday, October 21, 2013
CTI Adds Three Leaders in Blood Cancer Research and Development to SAB
Addition of Alan List, Ross Levine and Brian Druker to CTI's recently formed Scientific Advisory Board.
Monday, October 14, 2013
Market Access Granted in France for Aggressive NHL Treatment, PIXUVRI®
CT will reassess the ASMR rating for PIXUVRI within two years.
Wednesday, August 21, 2013
Daniel Von Hoff to Lead Cell Therapeutics' Scientific Advisory Board
Dr. Von Hoff will serve as Chairman of CTI's Scientific Advisory Board.
Wednesday, July 24, 2013
CTI Announces Results from Sub-Set Analyses of Data from Phase 3 EXTEND Clinical Trial
Results presented at 18th Congress of the European Hematology Association.
Monday, July 15, 2013
Market Access Granted in Italy for PIXUVRI®
Access granted by AIFA for the aggressive non-Hodgkin lymphoma treatment.
Monday, July 08, 2013
Cell Therapeutics Announces Resignation of Chief Medical Officer
Resignation of Steven E. Benner for personal reasons.
Monday, July 01, 2013
G-BA Issues Final Assessment Report for PIXUVRI®
Pricing negotiations to begin in June.
Tuesday, May 21, 2013
Scientific News
NIH Researchers Identify Striking Genomic Signature for Cancer
Institute has identified striking signature shared by five types of cancer.
CRI Develops Innovative Approach for Identifying Lung Cancer
Institute has developed innovative approach for identifying processes that fuel tumor growth in lung cancer patients.
Counting Cancer-busting Oxygen Molecules
Researchers from the Centre for Nanoscale BioPhotonics (CNBP), an Australian Research Centre of Excellence, have shown that nanoparticles used in combination with X-rays, are a viable method for killing cancer cells deep within the living body.
Crowdfunding the Fight Against Cancer
From budding social causes to groundbreaking businesses to the next big band, crowdfunding has helped connect countless worthy projects with like-minded people willing to support their efforts, even in small ways. But could crowdfunding help fight cancer?
Cancer Cells Kill Off Healthy Neighbours
Cancer cells create space to grow by killing off surrounding healthy cells, according to UK researchers working with fruit flies.
Cancer Drug Target Visualized at Atomic Resolution
New study using cryo-electron microscopy shows how potential drugs could inhibit cancer.
Genetic Mechanism Behind Cancer-Causing Mutations
Researchers at Indiana University has identified a genetic mechanism that is likely to drive mutations that can lead to cancer.
Future of Medicine Could be Found in a Tiny Crystal Ball
A Drexel University materials scientist has discovered a way to grow a crystal ball in a lab. Not the kind that soothsayers use to predict the future, but a microscopic version that could be used to encapsulate medication in a way that would allow it to deliver its curative payload more effectively inside the body.
"Gene Fusion" Drives Childhood Brain Cancers
Study co-led by Penn scientists highlights potential targets for future cancer therapies.
Enzyme Links Age-Related Inflammation, Cancer
Researchers have shown that an enzyme key to regulating gene expression -- and also an oncogene when mutated -- is critical for the expression of numerous inflammatory compounds that have been implicated in age-related increases in cancer and tissue degeneration.
SELECTBIO

Skyscraper Banner
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!