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).
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
- 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.