TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/13/2018
Start Date:April 2014
End Date:August 31, 2019

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The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The
trial is open-ended, which means patients will continue to take rociletinib until the study
doctor determines it is no longer beneficial for them.

This is a Phase 2, single arm, open-label, dual cohort, multicenter study evaluating the
safety and efficacy of rociletinib administered orally to patients with previously treated
mutant EGFR NSCLC.

Patients will be enrolled into 2 cohorts. Cohort A will enroll approximately 125 eligible
patients who are centrally confirmed T790M-positive. Cohort B will be a continuation of the
study and will enroll up to approximately 100 eligible patients who will be either centrally
confirmed T790M-positive or T790M-negative.

All patients (for Cohort A and B) should have experienced disease progression while on
treatment with the first single-agent EGFR-directed TKI (EGFR-TKI) for advanced/metastatic
NSCLC. One line of chemotherapy prior to the EGFR-TKI treatment is permissible.

The study (Cohorts A and B) will consist of a screening phase to establish study eligibility
and document baseline measurements, an open-label treatment phase, in which the patient will
receive rociletinib to ascertain safety and efficacy until disease progression as defined by
RECIST Version 1.1, clinical tumor progression, or unacceptable toxicity as assessed by the
investigator. For patients with clinical progression, radiographic assessment should be
performed to document evidence of radiographic progression.

Inclusion Criteria

- Histologically or cytologically confirmed metastatic or unresectable locally advanced
NSCLC

- Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20
insertion

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

- EGFR TKI treatment discontinued less than or equal to 30 days prior to planned
initiation of rociletinib

- The washout period for an EGFR inhibitor is a minimum of 3 days

- No intervening treatment between cessation of single agent EGFR TKI and planned
initiation of rociletinib

- Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior
neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent)

- Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1
or less

- Central laboratory confirmation of the presence of the T790M mutation in tumor tissue
in Cohort A and the presence or absence of the T790M mutation in tumor tissue in
Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable.
Biopsy material obtained from either primary or metastatic tumor tissue and sent to
the central laboratory must be within 60 prior to dosing study drug but following
disease progression on the first EGFR TKI

- Measurable disease according to RECIST Version 1.1

- Life expectancy of at least 3 months

- ECOG performance status of 0 to 1

- Minimum Age 18 years (in certain territories, the minimum age requirement may be
higher eg age 20 years in Japan and Taiwan)

- Adequate hematological and biological function, confirmed by defined laboratory values

- 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 i.e. patient known to have potentially fatal cancer present
for which he/she may be (but not necessarily) currently receiving treatment

- Patients with a history of malignancy that has been completely treated, with no
evidence of that cancer currently, are permitted to enrol in the trial provided all
chemotherapy was completed greater than 6 months prior and/or bone marrow transplant
greater than 2 years prior

- Known pre-existing interstitial lung disease

- Cohort A only: Patients with leptomeningeal carcinomatosis are excluded. Other central
nervous system (CNS) metastases are only permitted if treated, asymptomatic, and
stable (not requiring steroid for at least 4 weeks prior to the start of study
treatment). Cohort B only: Patients with CNS metastases or leptomeningeal
carcinomatosis are excluded.

- 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

- Any of the following cardiac abnormalities or history

- Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's
method (QTCF) greater than 450 msec

- Inability to measure QT interval on ECG

- Personal or family history of long QT syndrome

- Implantable pacemaker or implantable cardioverter defibrillator

- Resting bradycardia less than 55 beats/min

- Non-study related surgical procedures less than or equal to 7 days prior to
administration of rociletinib. In all cases, the patient must be sufficiently
recovered and stable before treatment administration

- Females who are pregnant or breastfeeding

- Refusal to use adequate contraception for fertile patients (females and males) while
on treatment and for 12 weeks after the last dose of rociletinib

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

- Any other reason the investigator considers the patient should not participate in the
study
We found this trial at
42
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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8940 N Kendall Dr # 300E
Miami, Florida 33176
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Alhambra, California 91801
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Amarillo, Texas 79106
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Arlington, Texas 76014
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Austin, Texas 78731
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Bakersfield, California 93309
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Beaumont, Texas 77702
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Bedford, Texas 76022
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Boston, Massachusetts 02215
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Burlington, Massachusetts 01805
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Dallas, Texas 75246
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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...
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Flower Mound, Texas 75028
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Fullerton, California
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Grand Junction, Colorado
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Houston, Texas 77030
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Latham, New York 12110
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Lone Tree, Colorado 80218
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Minneapolis, Minnesota 55405
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Niles, Illinois 60714
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Northridge, California 91325
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Philadelphia, Pennsylvania 19111
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Plano, Texas 75075
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Redondo Beach, California 90277
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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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...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94143
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San Luis Obispo, California 93401
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South Brisbane, New South Wales
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Vancouver, Washington 98684
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2811 Tieton Drive
Yakima, Washington 98902
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