A Phase 1/2 Study of the Safety and Efficacy of Rociletinib When Administered in Combination With Trametinib in Patients With Activating EGFR Mutation-positive Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC).

Trial Profile

A Phase 1/2 Study of the Safety and Efficacy of Rociletinib When Administered in Combination With Trametinib in Patients With Activating EGFR Mutation-positive Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC).

Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 29 Jul 2016

At a glance

  • Drugs Rociletinib (Primary) ; Trametinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Clovis Oncology
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 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.
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