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Rociletinib

DRUG7 trials

Sponsors

Clovis Oncology, Inc., Washington University School of Medicine

Conditions

Carcinoma, Non-Small-Cell LungLocally Advanced or Metastatic Non Small Cell Lung CancerNon-Small Cell Lung CancerNon-small Cell Lung CancerNonsmall Cell Lung Cancer

Phase 1

Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients
TerminatedNCT01526928
Clovis Oncology, Inc.Locally Advanced or Metastatic Non Small Cell Lung Cancer
Start: 2012-03-27End: 2018-08-27Updated: 2020-08-04
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
TerminatedNCT02580708
Clovis Oncology, Inc.Non-small Cell Lung Cancer
Start: 2015-09-30End: 2016-06-27Updated: 2018-10-02
A Phase 1b/2 Study of Safety and Efficacy of Rociletinib in Combination With MPDL3280A in Patients With Advanced or Metastatic EGFR-mutant NSCLC
TerminatedNCT02630186
Clovis Oncology, Inc.Non-small Cell Lung Cancer
Start: 2016-02-24End: 2017-09-05Updated: 2019-07-05

Phase 2

Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer
TerminatedNCT02147990
Clovis Oncology, Inc.Non-small Cell Lung Cancer
Start: 2014-06-16End: 2019-08-27Updated: 2020-08-12
Rociletinib Genomic Landscape in Non-small Cell Lung Cancer (NSCLC)
WithdrawnNCT02705339
Washington University School of MedicineCarcinoma, Non-Small-Cell Lung, Nonsmall Cell Lung Cancer, Non-Small Cell Lung Cancer
Start: 2016-05-31End: 2020-04-30Updated: 2016-05-17

Phase 3

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
TerminatedNCT02322281
Clovis Oncology, Inc.Non-small Cell Lung Cancer
Start: 2015-02-28End: 2018-03-29Updated: 2019-08-14

Unknown Phase

Rociletinib (CO-1686) USA Expanded Access Program
NCT02547675
Clovis Oncology, Inc.Non-small Cell Lung Cancer
Updated: 2018-09-25

Related Papers

Efficacy and Safety of Rociletinib Versus Chemotherapy in Patients With <i>EGFR</i>-Mutated NSCLC: The Results of TIGER-3, a Phase 3 Randomized Study.
2020-10-2614 citations
Cell-Free DNA Next-Generation Sequencing Prediction of Response and Resistance to Third-Generation EGFR Inhibitor.
2018-08-0755 citations
Improved EGFR mutation detection using combined exosomal RNA and circulating tumor DNA in NSCLC patient plasma.
2018-03-01186 citations
Outcome of EGFR mutant patirnts included in a clinical trial after progression on EGFR TKI.
Journal of Clinical Oncology2017-05-201 citations
A Highly Sensitive and Quantitative Test Platform for Detection of NSCLC EGFR Mutations in Urine and Plasma.
2016-07-25239 citations
Epidermal growth factor receptor (EGFR) genotyping of matched urine, plasma and tumor tissue from non-small cell lung cancer (NSCLC) patients (pts) treated with rociletinib.
Journal of Clinical Oncology2016-05-2032 citations
Updated results from TIGER-X, a phase I/II open label study of rociletinib in patients (pts) with advanced, recurrent T790M-positive non-small cell lung cancer (NSCLC).
Journal of Clinical Oncology2016-05-2011 citations
Inter- and intra-patient heterogeneity of resistance mechanisms to the mutant EGFR selective inhibitor rociletinib.
Journal of Clinical Oncology2016-05-204 citations
Rociletinib-associated cataracts in EGFR-mutant NSCLC.
Journal of Clinical Oncology2016-05-202 citations
TIGER-3: A phase 3 multinational open-label randomized study of rociletinib vs investigator-choice chemotherapy in patients (pts) with epidermal growth factor receptor mutant-positive (EGFRm) non-small cell lung cancer (NSCLC) progressing on prior EGFR tyrosine kinase inhibitor (TKI) therapy and doublet chemotherapy.
Journal of Clinical Oncology2016-05-202 citations
Abstract A31: Assessment of EGFR mutations in matched urine, plasma and tumor tissue in NSCLC patients treated with rociletinib (CO-1686)
Molecular Cancer Therapeutics2015-12-01
Efficacy of rociletinib (CO-1686) in plasma-genotyped T790M-positive non-small cell lung cancer (NSCLC) patients (pts).
Journal of Clinical Oncology2015-05-2054 citations
TIGER-3: A phase 3, open-label, randomized study of rociletinib vs cytotoxic chemotherapy in patients (pts) with mutant EGFR non-small cell lung cancer (NSCLC) progressing on prior EGFR TKI therapy and doublet chemotherapy.
Journal of Clinical Oncology2015-05-202 citations
Rociletinib in <i>EGFR</i>-Mutated Non–Small-Cell Lung Cancer
New England Journal of Medicine2015-04-29660 citations
How I Treat Patients with Lung Cancer Harboring EGFR T790M
Oncology Times2014-07-31
First-in-human evaluation of CO-1686, an irreversible, highly selective tyrosine kinase inhibitor of mutations of EGFR (activating and T790M).
Journal of Clinical Oncology2014-05-20143 citations
Abstract B120: Preclinical assessment of a mutant-selective covalent inhibitor of EGFR that overcomes T790M-mediated resistance in NSCLC.
Molecular Cancer Therapeutics2013-11-011 citations