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



Status:Active, not recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/13/2018
Start Date:March 2012
End Date:August 31, 2019

Use our guide to learn which trials are right for you!

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)

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.

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
afatinib.

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

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
study
We found this trial at
40
sites
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Athens, GA
Click here to add this to my saved trials
13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Camperdown, New South Wales 2050
?
mi
from
Camperdown,
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
?
mi
from
Duarte, CA
Click here to add this to my saved trials
8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
450 Lakeville Rd
Lake Success, New York 11040
(516) 734-8900
Monter Cancer Center The Monter Cancer Center is a unique facility dedicated to providing state-of-the-art...
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Morristown, New Jersey 07962
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey 07834
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32804
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84112
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Seattle, Washington 98104
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
12697 E 51st Street South
Tulsa, Oklahoma 74146
918-505-3200
Tulsa Cancer Institute, Pllc Now under the new name of Tulsa Cancer Institute, our specialists...
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials