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

Clavis Pharma Provides Update on Pivotal LEAP Trial with CP-4126

Published: Monday, October 22, 2012
Last Updated: Monday, October 22, 2012
Bookmark and Share
64% of the 360 patients enrolled in the study are hENT1-low.

Clavis Pharma ASA reports that Clovis Oncology, its partner for CP-4126 (also known as CO-101), has been informed by the Independent Data Monitoring Committee that 64% of the 360 patients enrolled into the pivotal LEAP study were classified as hENT1-low.

The hENT1-low patients comprise the target population in which the primary survival endpoint of the LEAP trial, which is evaluating CP-4126 in metastatic pancreatic cancer patients, will be assessed.

The final hENT1 classification is in line with the previously reported results, announced in January 2012, and those from retrospective analyses (the 002 study) of hENT1 expression in pancreatic cancer tissues, that approximately two thirds of metastatic pancreatic patients are likely to be hENT1-low.

Studies have shown that hENT1-low patients derive little or no benefit from standard gemcitabine therapy (refs 1-4).

The final size of the hENT1-low population among the 360 patients in the fully enrolled LEAP study also confirms that the trial is well-powered.

Top-line results from the trial are expected to be announced in the fourth quarter of 2012, and if positive, regulatory filings are anticipated in the US and Europe in mid-2013.

Olav Hellebø, Clavis Pharma CEO, said: "The size of the hENT1-low population for the primary endpoint analysis in the LEAP study confirms our belief that there is a significant proportion of pancreatic cancer patients who are not likely to benefit from standard gemcitabine therapy and that CP-4126 could provide a new treatment option for these patients. We look forward to results of the LEAP study later in 2012 with great anticipation.”


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 2,500+ scientific posters on ePosters
  • More than 3,800+ 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 Completes Patient Recruitment in Phase III CLAVELA Study in AML Patients
Top-line data are expected to be available in Q1 2013.
Thursday, December 06, 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 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
NIH Study Finds Calorie Restriction Lowers Some Risk Factors for Age-Related Diseases
Two-year trial did not produce expected metabolic changes, but influenced other life span markers.
Immunotherapy Agent Benefits Patients with Drug-Resistant Multiple Myeloma in First Human Trial
Daratumumab proved generally safe in patients, even at the highest doses.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Computerized Flexible Needles Prove Themselves in Biological Tissue
The advantage of the system is that you can avoid obstacles with the needles or critical tissues and that the system during the insertion of the needle in real time can adjust the path if, for example, the tissue deforms.
DARWIN 2 24-week Monotherapy Data in RA Confirm Previous Results
Safety profile in DARWIN 2 consistent with previous filgotinib RA studies.
Researchers Publish Landmark “Basket Study”
Researchers from Memorial Sloan Kettering Cancer Center (MSK) have announced results from the first published basket study, a new form of clinical trial design that explores responses to drugs based on the specific mutations in patients’ tumors rather than where their cancer originated.
Agricultural Intervention Improves HIV Outcomes
A multifaceted farming intervention can reduce food insecurity while improving HIV outcomes in patients in Kenya, according to a randomized, controlled trial led by researchers at UC San Francisco.
Overdose of Vitamin D in Teenagers May Lead to Increased Cholesterol Levels
Dosing obese teens with vitamin D shows no benefits for their heart health or diabetes risk, and could have the unintended consequences of increasing cholesterol and fat-storing triglycerides. These are the latest findings in a series of Mayo Clinic studies in childhood obesity.
Phase 2 Trials Underway for New Single Dose Malaria Treatment
The new drug, which prevents the malaria parasite from reproducing and spreading, is now undergoing Phase II clinical trials in humans.
Scroll Up
Scroll Down
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!