Reporting and Analysis Plan - ECHO Analyses From Randomized Controlled Trials of Dabrafenib to Evaluate the Potential for Cardiac Valve Abnormalities (201709)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40754
• EU PAS number:
  EUPAS7313
• Study ID:
  40754
• Official title and acronym:
  Reporting and Analysis Plan - ECHO Analyses From Randomized Controlled Trials of Dabrafenib to Evaluate the Potential for Cardiac Valve Abnormalities (201709)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This meta-analysis supported an FDA post-marketing requirement (PMR) to further investigate independently reviewed echocardiogram (ECHO) results for subjects treated with dabrafenib, either as monotherapy or in combination with other anti-cancer therapies on randomized controlled clinical trials. These analyses evaluated the potential for cardiac valve abnormalities in patients treated with dabrafenib based on preclinical findings. The study was cancelled with no patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 17/09/2013

Actual: 17/09/2013

Study start date

Planned: 17/09/2013

Actual: 17/09/2013

Date of final study report

Planned: 20/09/2021

Actual: 17/09/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Study protocol

Initial protocol

gsk2118346-rap-cardiacvalve-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

CDRB436A2401