Selinexor in Advanced Liposarcoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:12 - Any
Updated:4/3/2019
Start Date:December 2015
End Date:March 2020
Contact:Michael Kauffman, M.D., Ph.D.
Email:Mkauffman@karyopharm.com

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A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of
patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 279
total patients will be randomized to study treatment (selinexor or placebo).

In the Phase 2 portion of the study, 57 patients were randomized to selinexor (60 mg) or
placebo at a 1:1 allocation ratio.

In the Phase 3 portion of the study, approximately 222 patients will be randomized to
selinexor (60 mg) or placebo with a 2:1 allocation ratio.

Patients who progress during the blinded portion of the study will be unblinded and if
receiving:

- placebo, may cross over to open-label selinexor (60mg twice weekly)

- selinexor, will be withdrawn from further treatment and followed for survival

Study treatment will be given twice weekly on Day 1 and Day 3 during Weeks 1-6 of each
six-week (42 day) cycle until disease progression or intolerability.

Treatment will continue until one or more of the following occurs:

- Disease progression, as defined by RECIST v1.1 Response Criteria

- Clinical progression, as determined by the treating physician

- Unacceptable AEs or failure to tolerate study treatment

- Patient withdrawal

- Patient discontinuation due to non-compliance

Inclusion Criteria:

1. Patients ≥12 years of age

2. Body surface area (BSA) ≥ 1.2 m2

3. Histologic evidence of DDLS at any time prior to randomization AND current evidence of
DDLS requiring treatment

4. Must have measurable disease per RECIST v1.1 Response Criteria

5. Radiologic evidence of disease progression within 6 months prior to randomization. If
the patient received other intervening therapy after documented disease progression,
further disease progression must be documented after the completion of the intervening
therapy

6. Must have had at least two (2) prior lines of systemic therapy for liposarcoma (not to
exceed 5 prior lines)

7. If patient received any previous systemic therapy, the last dose must have been ≥ 21
days prior to randomization (or ≥ 5 half-lives of that drug - whichever is shorter)
with all clinically significant therapy- related toxicities having resolved to less
than or equal to Grade 1

Exclusion Criteria:

1. Patients with pure WDLS, myxoid/round cell or pleomorphic tumor histologic subtypes.

2. Known active Hepatitis B (HepB), Hepatitis C (HepC) or human immunodeficiency virus
(HIV) infection.

3. Known central nervous system metastases
We found this trial at
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Charles Forscher, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Edwin Choy, MD, PhD
Phone: 617-724-4000
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Steven Attia, DO
Phone: 904-953-7290
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Los Angeles, California 90095
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Principal Investigator: Bartosz Chmielowski, MD
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Seth Pollack, MD
Phone: 520-609-0301
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Scott Schuetze, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Christian Meyer, MD
Phone: 410-955-8893
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Andrew Wagner, MM, PhD
Phone: 617-582-7162
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brussels,
Principal Investigator: Jacques DeGreve, MD
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Mark Agulnik, FRCPC, MD
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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460 West 10th Avenue
Columbus, Ohio 43210
Principal Investigator: James Chen, MD
Phone: 614-685-9754
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Denver, Colorado 80291
Principal Investigator: Victor Villalobos, MD, PhD
Phone: 720-848-0467
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20 Duke Medicine Circle
Durham, North Carolina 27710
Principal Investigator: Richard Riedel, M.D.
Phone: 919-681-1883
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Houston, Texas 77030
Principal Investigator: Neeta Somaiah, MD
Phone: 713-563-5056
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Nashville, Tennessee 37212
Principal Investigator: Elizabeth Davis, MD
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Principal Investigator: Hari Deshpande, MD
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Mrinal Gounder, MD
Phone: 646-888-4167
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 11042
Principal Investigator: Tony Philip, MD
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Gary Schwartz, MD
Phone: 646-317-6041
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Philadelphia, Pennsylvania 19111
Principal Investigator: Margaret von Mehren, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Lee Hartner, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Melissa Burgess, MD
Phone: 412-692-4724
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Portland, Oregon 97239
Principal Investigator: Christopher Ryan, MD
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Scott Okuno, MS
Phone: 507-266-5027
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Brian Van Tine, MD, PhD
Phone: 314-362-7997
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Santa Monica, California 90403
Principal Investigator: Sant Chawla, MD
Phone: 310-552-9999
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Kristen Ganjoo, MD
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