Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Clavis Pharma Completes Patient Recruitment in Phase III CLAVELA Study in AML Patients

Published: Thursday, December 06, 2012
Last Updated: Thursday, December 06, 2012
Bookmark and Share
Top-line data are expected to be available in Q1 2013.

Clavis Pharma ASA has announced that is has reached the enrolment target for its Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukaemia (AML).

Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine, which is routinely used in the treatment of AML.

The CLAVELA study is a 380-patient Phase III open-label randomized, controlled trial comparing elacytarabine with the investigator’s choice of treatment in patients with relapsed or refractory AML.

The study is being conducted at 76 clinical sites in the USA, Canada, Europe and Australia. The primary endpoint of the study is overall survival (OS) and the objective is to demonstrate superiority of elacytarabine over current therapies.

Patients have been randomized to each arm of the study and the difference in OS and other parameters, including response rates, duration of response, and safety profile of elacytarabine, will be measured.

Olav Hellebø, Clavis Pharma CEO, commented: “The completion of patient recruitment for our Phase III CLAVELA study is an important achievement for Clavis Pharma and keeps us on track to report top-line efficacy data in Q1 2013. The results we have seen in the earlier Phase II trial with elacytarabine and the elacytarabine/idarubicin combination study in early stage AML patients have been encouraging, and we hope that this novel agent can become an effective new treatment option for AML patients.”


Further Information
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 2,400+ scientific posters on ePosters
  • More Than 3,700+ 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

Promising Efficacy from Elacytarabine/idarubicin Combination in Phase II AML Study
Data presented at the American Society of Hematology annual meeting.
Monday, December 10, 2012
Clavis Pharma Announces Results of the LEAP Study of CP-4126 in Metastatic Pancreatic Cancer
Clavis Pharma continues to focus on elacytarabine and its Phase III CLAVELA study in leukaemia patients.
Monday, November 19, 2012
Clavis Pharma Provides Update on Pivotal LEAP Trial with CP-4126
64% of the 360 patients enrolled in the study are hENT1-low.
Monday, October 22, 2012
Clavis Pharma Announces Size of Initial hENT1-low Population in Pivotal LEAP Trial with CP-4126
65 percent of the initial 250 patients enrolled in the study are hENT1-low.
Monday, March 05, 2012
Clavis Pharma - Update Regarding Phase III CLAVELA Trial
Top line results are expected in the first quarter of 2013, one quarter delayed.
Tuesday, January 17, 2012
Clovis Oncology Expands the Observational Study to Determine Patient Stratification in Pivotal LEAP Clinical Trial with CP-4126
New, improved hENT1 biomarker assay developed.
Monday, January 02, 2012
Clavis Pharma Announces the Completion of Study 002
Low hENT1 cut-off level determined for pivotal LEAP study of CP-4126 in patients with pancreatic cancer.
Friday, October 28, 2011
Clavis Pharma Second Quarter and First Half Report 2011
Clavis Pharma and Clovis Oncology expanded the LEAP study, evaluating CP-4126 vs. gemcitabine in pancreatic cancer patients.
Friday, August 26, 2011
Clavis Pharma Expands Phase III CLAVELA Study in Patients With Acute Myeloid Leukaemia
Top line data are now expected to be available in Q4 2012.
Friday, August 26, 2011
Clavis Pharma Appoints Nicholas Adams as Chief Business Officer
Nicholas Adams replaces Jan Alfheim, who has taken up the position of Managing Director at Nordic Nanovector AS.
Tuesday, July 12, 2011
Clavis Pharma Licenses LVT Compound CP-4033 to Translational Therapeutics for Development in Aggressive Thyroid Tumours
Clavis Pharma and Translational Therapeutics have entered into a strategic licensing agreement regarding the development and commercialization of CP-4033.
Monday, June 06, 2011
Clavis Pharma Receives Government Grant to Develop hENT1 Biomarker Assay for Targeted Therapy of AML Patients
Award of up to NOK 14 million to develop a companion diagnostic that can help preselect AML patients who would benefit most from Clavis Pharma's novel cancer drug elacytarabine.
Wednesday, June 01, 2011
Clavis Pharma Elects Robert J. Spiegel to its Board of Directors
Dr. Spiegel has gained extensive clinical and corporate development experience in the biotechnology and pharmaceutical industry in a career spanning over 30 years.
Monday, May 30, 2011
Clavis Pharma’s CP-4126 Enters New Phase II Clinical Trial in Pancreatic Cancer Patients
The trial will investigate the use of CP-4126 as a 2nd line treatment for advanced, metastatic pancreatic cancer in patients refractory to 1st line gemcitabine treatment.
Friday, February 04, 2011
Clavis Pharma and Clovis Oncology Extend Partnership and Sign new $205 Million Deal
Partnership is aimed for the development and commercialization of anti-cancer agent CP-4126 in Asia and rest of the World.
Friday, November 12, 2010
Scientific News
RNAi Screening Trends
Understand current trends and learn which application areas are expected to gain in popularity over the next few years.
Diagnostic Test Developed for Enterovirus D68
researchers at Washington University School of Medicine in St. Louis have developed a diagnostic test to quickly detect enterovirus D68 (EV-D68), a respiratory virus that caused unusually severe illness in children last year.
How a Kernel Got Naked and Corn Became King
Ten thousand years ago, a golden grain got naked, brought people together and grew to become one of the top agricultural commodities on the planet.
Sweet Revenge Against Superbugs
A special type of synthetic sugar could be the latest weapon in the fight against superbugs.
New Material Opens Possibilities for Super-Long-Acting Pills
A pH-responsive polymer gel could create swallow able devices, including capsules for ultra-long drug delivery.
How To Keep Your Rice Arsenic-Free
Researchers at Queen’s University Belfast have made a breakthrough in discovering how to lower worrying levels of arsenic in rice that is eaten all over the world.
New Tool For Investigating RNA Gone Awry
A new technology – called “Sticky-flares” – developed by nanomedicine experts at Northwestern University offers the first real-time method to track and observe the dynamics of RNA distribution as it is transported inside living cells.
Computer Model Could Explain how Simple Molecules Took First Step Toward Life
Two Brookhaven researchers developed theoretical model to explain the origins of self-replicating molecules.
New Tech Enables Epigenomic Analysis with a Mere 100 Cells
A new technology that will dramatically enhance investigations of epigenomes, the machinery that turns on and off genes and a very prominent field of study in diseases such as stem cell differentiation, inflammation and cancer has been developed by researchers at Virginia Tech.
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
Scroll Up
Scroll Down
Skyscraper Banner

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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!