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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase II, Phase IBiomarker/Laboratory analysis, Treatment18 and overCO-1686-008
NCI-2012-00742, NCT01526928

Trial Description


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


Further Study Information

Lung cancer remains the most common cancer worldwide with non-small cell lung cancer

accounting for 85% of cases. Cytotoxic chemotherapy has been the mainstay of patients with

NSCLC; however, survival rates remain low and toxicity is significant. Molecularly targeted

therapies have proven to be superior to chemotherapy for NSCLC patients whose tumors have

mutations in EGFR. Recent studies have established tyrosine kinase inhibitors (TKIs) as the

gold standard for treating EGFR-mutation-positive NCSLC. However, patients on TKIs

eventually progress, and in approximately 50% of cases, progression is due to development of

an additional mutation called T790M. There are currently no approved therapies for patients

who progress on TKIs. Rociletinib may provide an effective therapy for a patient population

with few alternative treatment options. Nonclinical data demonstrate that rociletinib

inhibits T790M. It is anticipated that rociletinib may promote cell death in tumor cells

with the T790M mutation, thus providing possible therapeutic benefit in patients who have

developed T790M-mediated resistance to first generation TKIs.

This is a two-part, open-label study of oral rociletinib administered daily in previously

treated NSCLC patients who have documented evidence of an activating mutation in the EGFR

gene and have failed treatment with an EGFR inhibitor such as erlotinib, gefitinib or


This study will include 2 parts:

Phase 1 (completed enrolment): Dose-escalation Period with 21-day cycles; optional

Treatment Extension Period starting on Day 22

Phase 2 (currently enrolling): Evaluation of activity and safety in patients with the T790M

EGFR mutation who have:

Cohort A - Progressed on EGFR directed therapy (irrespective of the number and order of

previous lines of NSCLC therapy) or Cohort B - Progression on the first single agent EGFR

directed therapy received and also had no more than one previous line of chemotherapy

Eligibility Criteria

Inclusion Criteria:

Measureable disease according to RECIST Version 1.1

Documented evidence of T790M mutation in EGFR following disease progression on the

first single agent EGFR TKI.

Disease progression confirmed by radiologic assessment while on treatment with the

first single agent EGFR TKI and

Disease progression confirmed by radiologic assessment while on treatment with EGFR-


All patients must meet the following inclusion criteria:

1. Metastatic or unresectable locally advanced NSCLC

2. Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion

3. Biopsy of either primary or metastatic tumor tissue within 60 days of dosing

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

5. Minimum age of 18 years

6. Adequate hematological and biological function

7. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any

study-specific evaluation

Phase 2 Cohorts must also meet the following inclusion criteria:

Exclusion Criteria:

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Clovis Oncology

    Trial Sites



    City of Hope Comprehensive Cancer Center

    Karen Lynn Reckamp
    Principal Investigator

    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    Jonathan W Goldman
    Principal Investigator


    UC Irvine Health/Chao Family Comprehensive Cancer Center

    Sai-Hong Ignatius Ou
    Principal Investigator


    University of California Davis Comprehensive Cancer Center

    David R. Gandara
    Principal Investigator


    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    David Ross Camidge
    Principal Investigator

    District of Columbia

    MedStar Georgetown University Hospital

    Stephen V. Liu
    Principal Investigator


    University of Maryland/Greenebaum Cancer Center

    Martin J. Edelman
    Principal Investigator


    Dana-Farber Cancer Institute

    Geoffrey Raymond Oxnard

    Geoffrey Raymond Oxnard
    Principal Investigator


    Massachusetts General Hospital

    Lecia Van Dam Sequist
    Principal Investigator


    Barbara Ann Karmanos Cancer Institute

    Shirish M. Gadgeel
    Principal Investigator

    New York
    New York

    Memorial Sloan-Kettering Cancer Center

    Helena Yu
    Principal Investigator


    University of Pennsylvania/Abramson Cancer Center

    Corey J. Langer
    Principal Investigator


    Vanderbilt University/Ingram Cancer Center

    Leora Horn
    Principal Investigator


    UT Southwestern/Simmons Cancer Center-Dallas

    Joan Hoff Schiller
    Principal Investigator

    Salt Lake City

    Huntsman Cancer Institute/University of Utah

    Wallace Lovell Akerley
    Principal Investigator


    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Christina S Baik
    Principal Investigator

    Link to the current record.
    NLM Identifer NCT01526928

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the record via the link above for more information about participating sites.