A phase I trial of a tablet formulation of rociletinib (CO 1686) in Japanese subjects
Phase of Trial: Phase I
Latest Information Update: 05 May 2016
At a glance
- Drugs Rociletinib (Primary)
- Indications Non-small cell lung cancer
- Focus Adverse reactions; Pharmacokinetics
- 05 May 2016 According to Clovis Oncology media release, company was notified that it could anticipate receiving a Complete Response Letter (CRL) for the rociletinib NDA on or before the PDUFA date of June 28, 2016 but the FDA issued a CRL stating that the application is not ready for approval. Hence, company has terminated enrollment in all ongoing studies.
- 05 May 2016 Status changed from active, no longer recruiting to discontinued, as reported by Clovis Oncology media release.
- 06 May 2015 Status changed from recruiting to active, no longer recruiting, according to a Clovis Oncology media release.