Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL



Status:Terminated
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2014
End Date:June 2016

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Azacitidine With or Without Birinapant With a Single Arm Open-Label Run-In Phase in Subjects With Higher Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

This is a randomized double blind placebo controlled study of azacitidine with or without
birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or
myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and
mechanistic studies support that azacitidine may modulate pathways that enable
birinapant-mediated anti-tumor activity.

This is a randomized double blind placebo controlled study of azacitidine with or without
birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or
myelomonocytic leukemia (CMMoL)

The primary purpose of this study is :

-To compare the relative effect of azacitidine plus birinapant versus azacitidine plus
placebo on response rate in patients with higher-risk MDS, secondary MDS or CMMoL.

The secondary purpose of this study is to compare effect of azacitidine plus birinapant
relative to azacitidine with placebo on:

- Hematologic improvement

- Relapse free survival

- Time to respond

- Change in transfusion requirements

- Duration of response

- Overall survival

- Adverse events

The exploratory objective of this study is to assess exploratory translational biomarkers
for antitumor effects.

key Inclusion Criteria:

- Morphologically confirmed diagnosis of MDS/CMMoL according to FAB or WHO
classification, including RAEB-t and MDS/MPN

- International prognostic score-revised (IPSS-R) of >3.5 (Intermediate, High or Very
High)

- Previously untreated with hypomethylating agents for MDS/CMMoL

- Performance status of 0, 1 or 2 by the ECOG scale

- Adequate renal and liver function

- Female subjects of childbearing potential must have a negative serum pregnancy test
at screening within 96 hours prior to the first study dose.

- Female subjects of childbearing potential and male subjects with partners of
childbearing potential should ensure use of a highly effective method of birth
control as defined by the investigator, for example, those which result in a low
failure rate (i.e., less than 1% per year) when used consistently and correctly
during the study and for a period of 3 months following the last dose of any drug
administered during the study.

Key Exclusion Criteria:

- Relapsed or refractory to hypomethylating agents

- Acute myeloid leukemia (AML), except those patients with RAEB-t who are not
candidates for intensive AML therapy.

- Participated in any interventional study within 4 weeks of randomization or 5 half
lives (whichever is longer).

- Received any hematopoietic growth factors within 14 days prior to screening.

- Prior malignancy or secondary malignancy within the prior 2 years (except in situ
cervical cancer, squamous cell carcinoma or basal cell carcinoma of the skin).

- known diagnosis of human immunodeficiency virus or chronic active Hep B or C.

- Uncontrolled hypertension

- Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or
clinically significant cardiac disease

- Lack of recovery of prior adverse events to Grade ≤1 severity (National Cancer
Institute Common Terminology Criteria for Adverse Events version 4) (except alopecia)
due to therapy administered prior to the initiation of study drug dosing.

- Nursing or pregnant.

- Known allergy or hypersensitivity to any of the formulation components

- Any concurrent disease and/or medical condition that, in the opinion of the
Investigator, would prevent the subject's participation.

- History of cranial nerve palsy.

- Being treated with anti-TNF therapies or has been treated with an anti-TNF therapy
within 5 half-lives of randomization.
We found this trial at
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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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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Winter Haven, Florida 33880
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Ann Arbor, Michigan 48197
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Camperdown, New South Wales 2050
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Chattanooga, Tennessee 37404
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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East Setauket, New York 11733
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Glendale, Arizona 85306
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Glendale, Arizona 85304
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32256
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Jacksonville, Florida 32216
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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...
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Los Angeles, California 90095
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601 South Floyd Street
Louisville, Kentucky 40202
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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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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New Orleans, Louisiana 70112
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oceanside, California 92056
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Worcester, Massachusetts 01655
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