Study identification

PURI

https://redirect.ema.europa.eu/resource/39394

EU PAS number

EUPAS7317

Study ID

39394

Official title and acronym

Reporting and Analysis Plan - Evaluation of Secondary Malignancies in Patients Treated with Dabrafenib in Randomized, Controlled Trials (201710)

DARWIN EU® study

No

Study countries

United States

Study description

This meta-analysis supports an FDA-proposed Clinical Post-Marketing Requirement (PMR) dated May 29, 2013 requesting cumulative safety analyses of new malignancies, including cutaneous squamous cell carcinoma, in all ongoing and subsequently initiated randomized controlled clinical trials through 2020 that use Tafinlar (dabrafenib) capsules alone or in combination with other anti-cancer drugs. There are currently four ongoing randomized, comparative trials that will eventually contribute to these analyses: BRF113683, MEK115306, MEK116513, and BRF115532. The results of BRF113683 were reported in the clinical study report titled ‘A Phase III randomized, open-label study comparing dabrafenib to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma’ (dated June 2012). The other 3 trials have not reached their primary endpoint analysis as of June 2013. The first Interim Report will contain data from only BRF113683 and be submitted in October 2013, subsequent reports will include data from other included studies.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Clinical Disclosure Officer Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis
Study protocol
Initial protocol

GSK2118436-reporting-and-analysis-plan-redact

English (196.07 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)