Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/18/2018
Start Date:June 2012
End Date:November 2021

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Phase 1/2, First-in-Human, Dose-Escalation Study of X-396 (Ensartinib) in Patients With Advanced Solid Tumors and Expansion Phase in Patients With ALK-positive Non-Small Cell Lung Cancer

This is the first human study to use X-396 (ensartinib), a drug being developed for treatment
of advanced cancers. The initial purpose of the study is to determine the largest amount of
X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended
Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor
activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide
early information on how the body handles the drug (pharmacokinetics) and on the efficacy of
X-396.

This is the first study of X-396 (ensartinib) in humans and the investigational drug will be
given as a once or twice daily oral dose in 28 day cycles until there is disease progression
or unacceptable safety issues. X-396 will be given to small groups of patients (1 - 6) at
each dose level and the patients will be observed to see if there are any adverse safety
effects. As long as there are no unacceptable safety issues after 28 days, the dose of X-396
will be increased for the next group of patients. This process will continue until the
maximum tolerated dose (MTD) of X-396 is reached. Once the MTD is reached, up to 170
additional patients will also be given X-396 to further determine the activity of X-396 in
patients with ALK-positive non-small cell lung cancer. These additional patients will be
enrolled in the following expansion cohorts: ALK TKI-naïve patients, patients that progressed
on crizotinib, patients that progressed on one or more 2nd generation ALK TKIs (patients may
or may not have also received prior crizotinib), including patients with asymptomatic CNS
metastases.

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of advanced solid tumor
malignancy. Patients may be ALK TKI-naive or may have received prior crizotinib and/or
second generation ALK TKIs. In addition, patients with a known ALK 1198 mutation will
be allowed.

-For the expanded cohort portion of the study, patients must have NSCLC with ALK
genomic alterations; however, patients will be allowed to enroll based on local
FDA-approved ALK results.

2. Eastern Cooperative Group ECOG) Performance Status score of 0 or 1.

3. Ability to swallow and retain oral medication.

4. Adequate organ system function.

5. Patients with treated or untreated asymptomatic CNS metastases may be allowed to
enroll.

6. Male patients willing to use adequate contraceptive measures.

7. Female patients who are not of child-bearing potential, and female patients of
child-bearing potential who agree to use adequate contraceptive measures.

8. Patients must be ≥ 18 years of age.

9. Patients must have measurable or evaluable disease for the dose escalation portion of
the study and measurable disease for the expanded cohort portion of the study (except
for patients in the CNS metastases and leptomeningeal cohorts).

10. Willingness and ability to comply with the trial and follow-up procedures.

11. Ability to understand the nature of this trial and give written informed consent.

Exclusion Criteria:

1. Patients currently receiving cancer therapy.

2. Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter)
prior to the first dose of X-396. A minimum of 10 days between treatment and X-396 and
2 days between ALK TKI and X-396.

3. Any major surgery, radiotherapy, or immunotherapy within the last 21 days (focal
radiation does not require a washout period; ≥4 weeks for WBRT). Chemotherapy regimens
with delayed toxicity within the last 4 weeks. Chemotherapy regimens given
continuously or on a weekly basis with limited potential for delayed toxicity within
the last 2 weeks.

4. Prior stem cell transplant.

5. Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically
related to X-396 (e.g., crizotinib) or to the active ingredient of X-396.

6. Patients with primary CNS tumors are ineligible.

7. Patients receiving CYP3A substrates with narrow therapeutic indices, strong CYP3A
inhibitors, and strong CYP3A inducers.

8. Concomitant use of herbal medications at least 7 days prior to the first dose of study
drug and throughout participation in the trial.

9. Females who are pregnant or breastfeeding.

10. Presence of active gastrointestinal (GI) disease or other condition that will
interfere significantly with the absorption, distribution, metabolism, or excretion of
X-396.

11. Clinically significant cardiovascular disease.

12. Patients who are immunosuppressed (including known HIV infection), have a serious
active infection at the time of treatment, have known hepatitis C, or have any serious
underlying medical condition that would impair the ability of the patient to receive
protocol treatment.

13. Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the protocol.

14. Concurrent condition that in the investigator's opinion would jeopardize compliance
with the protocol or would impart excessive risk associated with study participation
that would make it inappropriate for the patient to be enrolled.

15. Inability or unwillingness to comply with study and/or follow-up procedures outlined
in the protocol.
We found this trial at
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Houston, Texas 77030
Principal Investigator: George Blumenschein, MD
Phone: 855-873-4321
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Haiying Cheng, MD
Phone: 718-405-8539
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Richard Hall, MD
Phone: 434-297-4110
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Rachel Sanborn, MD
Phone: 503-215-2613
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Karen Zeman, M.D.
Phone: 301-319-4599
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Geoffrey Oxnard
Phone: 617-632-6049
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Carol Sherman, MD
Phone: 843-792-5853
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Gregory Otterson, MD
Phone: 614-685-5414
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Karen Reckamp, M.D.
Phone: 626-218-4438
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Hershey, Pennsylvania 17033
Principal Investigator: Chandra Belani, MD
Phone: 717-531-1003
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La Jolla, California 92093
Principal Investigator: Sandip Patel, M.D.
Phone: 858-822-5369
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Loma Linda, California 92354
Principal Investigator: Hamid Mirshahidi, MD
Phone: 909-558-4050
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Los Angeles, California 90033
Principal Investigator: Jorge Nieva, MD
Phone: 323-865-3962
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Ticiana Leal, M.D.
Phone: 608-262-8665
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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Morgantown, West Virginia
Principal Investigator: Patrick C Ma, MD, MSc
Phone: 304-581-1158
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Jeffrey Infante, MD
Phone: 615-524-4155
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Leora Horn, MD
Phone: 800-811-8480
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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550 1st Ave
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(212) 263-7300
Principal Investigator: Elaine Shum
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New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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Philadelphia, Pennsylvania 19111
Principal Investigator: Jessica Bauman
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660 S Euclid Ave
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(314) 362-5000
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450 Serra Mall
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(650) 723-2300
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3 Edmund D. Pellegrino Road
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Tampa, Florida 33612
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Phone: 813-745-1036
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