Phase I trial of pharmacokinetics of CO 1686 (new tablet vs original capsule formulation) in volunteers.

Trial Profile

Phase I trial of pharmacokinetics of CO 1686 (new tablet vs original capsule formulation) in volunteers.

Discontinued
Phase of Trial: Phase I

Latest Information Update: 05 May 2016

At a glance

  • Drugs Rociletinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Pharmacokinetics
  • Most Recent Events

    • 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 recruiting to discontinued, as reported by Clovis Oncology media release.
    • 01 Nov 2013 Results were presented at the 15th World Conference on Lung Cancer in Sydney in October 2013.
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