Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously T… (NCT01526928) | Clinical Trial Compass
TerminatedPhase 1/2
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
United States612 participantsStarted 2012-03-27
Plain-language summary
Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Metastatic or unresectable locally advanced NSCLC
✓. Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion
✓. Biopsy of either primary or metastatic tumor tissue within 60 days of dosing
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
✓. Minimum age of 18 years
✓. Adequate hematological and biological function
✓. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation
Exclusion criteria
✕. Documented evidence of an Exon 20 insertion activating mutation in the EGFR gene
✕. Active second malignancy
✕. Known pre-existing interstitial lung disease
What they're measuring
1
Percentage of T790M Positive Patients With Confirmed Response Per Investigator
Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 42 months
2
Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment
Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 36 months
. Patients with Leptomeningeal carcinomatosis are excluded. Other CNS metastases are only permitted if treated, asymptomatic and stable (not requiring steroids for at least 4 weeks prior to start of study treatment).
✕. Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib
✕. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib
✕. Prior treatment with rociletinib or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR