Therapy Detail

Therapy Name Rociletinib
Therapy Description

Rociletinib (CO-1686) is a third-generation EGFR TKI inhibitor and inhibits mutant forms of EGFR including T790M (PMID: 24410791).


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Drug Name Trade Name Synonyms Drug Classes Drug Description
Rociletinib CO1686 EGFR Inhibitor 3rd gen 16 Rociletinib (CO-1686) is a third-generation EGFR TKI inhibitor and inhibits mutant forms of EGFR including T790M (PMID: 24410791).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Clinical Trial Phase Therapies Title Recruitment Status
NCT02147990 Phase II Rociletinib TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) Active, not recruiting
NCT01526928 Phase Ib/II Rociletinib Study to Evaluate Safety, Pharmacokinetics, and Efficacy of CO-1686 in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients Completed
NCT02705339 Phase II Rociletinib Rociletinib Genomic Landscape in Non-small Cell Lung Cancer (NSCLC) Withdrawn
NCT02547675 Phase I Rociletinib Rociletinib (CO-1686) USA Expanded Access Program No longer available
NCT02186301 Phase II Rociletinib Erlotinib TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR Mutant NSCLC Who Have Not Had Any Previous EGFR Directed Therapy Terminated
NCT02580708 Phase Ib/II Trametinib Rociletinib 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) Terminated
NCT02322281 Phase III Pemetrexed Gemcitabine Paclitaxel Docetaxel Rociletinib TIGER-3 Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy Terminated