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

Not Recruiting

Trial ID: NCT01526928


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.

Official Title

A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral Rociletinib in Patients With Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology


Inclusion Criteria -

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:

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

   - Disease progression confirmed by radiologic assessment while on treatment with the
   first single agent EGFR TKI and

   - Documented evidence of T790M mutation in EGFR following disease progression on the
   first single agent EGFR TKI.

   - Measureable disease according to RECIST Version 1.1

Exclusion Criteria -

Any of the following criteria will exclude patients from study participation:

   1. Documented evidence of an Exon 20 insertion activating mutation in the EGFR gene

   2. Active second malignancy

   3. Known pre-existing interstitial lung disease

   4. 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).

   5. Treatment with prohibited medications less than or equal to 14 days prior to treatment
   with rociletinib

   6. 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

   7. Prior treatment with rociletinib or other drugs that target T790M positive mutant EGFR
   with sparing of wild type EGFR

   8. Certain cardiac abnormalities or history

   9. Non-study related surgical procedures less than or equal to 7 days prior to
   administration of rociletinib

10. Females who are pregnant or breastfeeding

11. Refusal to use adequate contraception for fertile patients (females and males) for 12
   weeks after the last dose of rociletinib

12. Presence of any serious or unstable concomitant systemic disorder incompatible with
   the clinical study

13. Any other reason the investigator considers the patient should not participate in the


drug: Rociletinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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