Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
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

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

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’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
Making It Personal
Cancer vaccine linked to increased immune response against leukemia cells.
Gene Therapy Maintains Clotting Factor for Hemophilia Patients
Following a single gene therapy dose, the highest levels of an essential blood clotting factor IX were observed in hemophilia B patients.
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.
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!