Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer



Status:Completed
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:June 2012
End Date:June 2016

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A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export/SINE™ Compound KPT-330 in Patients With Advanced Hematological Malignancies

The purpose of this research study is to find out more information relating to the highest
dose of KCP-330 that can be given safely and side effects it may cause, to examine how the
body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the
effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its
effectiveness in treating cancer.


Inclusion Criteria

1. Malignancies that are refractory to or intolerant of established therapy known to
provide clinical benefit. Patients must not be candidates for anti-tumor regimes known
to provide clinical benefit.

2. All patients must have evidence of progressive disease on study entry.Previously
untreated patients who are not chemotherapy candidates on Arm 2 may have advanced
disease (without clear progression). There is no upper limit on the number of prior
treatments provided that all inclusion criteria are met and exclusion criteria are not
met.

Exclusion Criteria

1. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks
prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1
day 1.

2. Patients with active graft versus host disease after allogeneic stem cell
transplantation. At least 3 months must have elapsed since completion of allogeneic
stem cell transplantation except for patients with AML, where at least 2 months must
have elapsed;

3. Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or
HBsAg (HBV surface antigen);

4. Patients with active CNS malignancy. Asymptomatic small lesions are not considered
active. Treated lesions may be considered inactive if they are stable for at least 3
months. Patient with malignant cells in their cerebrospinal fluid (CSF) without CNS
symptom may be included.

5. Significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting
or diarrhea.

6. Grade ≥2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).

7. Macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity.

8. In the opinion of the investigator, patients who are significantly below their ideal
body weight.
We found this trial at
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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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...
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Calgary, Alberta
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Canton, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Houston, Texas 77030
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New York, New York 10065
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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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Tampa, Florida 33612
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Tampa, FL
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