Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer
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ClinicalTrials.gov Identifier: NCT01607892 |
Recruitment Status :
Completed
First Posted : May 30, 2012
Last Update Posted : August 29, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hematological Malignancies | Drug: KPT-330 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 285 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: selinexor |
Drug: KPT-330
Other Name: Selinexor |
- Number of participants with Adverse Events [ Time Frame: 2 and 12 months ]Severity of Adverse Events
- Area under the plasma concentration versus time curve (AUC) of KPT-330 [ Time Frame: 2 and 12 months ]Changes in AUC over time

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- 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.
- 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
- 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.
- 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;
- Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen);
- 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.
- Significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.
- Grade ≥2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
- Macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity.
- In the opinion of the investigator, patients who are significantly below their ideal body weight.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607892
United States, Florida | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Weill Cornell Medical Center | |
New York, New York, United States, 10065 | |
United States, Ohio | |
Gabrail Cancer Center Research | |
Canton, Ohio, United States, 44718 | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Canada, Alberta | |
Tom Baker Cancer Centre | |
Calgary, Alberta, Canada, T2W 4N2 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5T 2M9 | |
Denmark | |
Rigshospitalet | |
Copenhagen, Denmark, 2100 |
Study Director: | Michael Kauffman, MD, Ph.D | Karyopharm Therapeutics Inc |
Responsible Party: | Karyopharm Therapeutics Inc |
ClinicalTrials.gov Identifier: | NCT01607892 |
Other Study ID Numbers: |
KCP-330-001 |
First Posted: | May 30, 2012 Key Record Dates |
Last Update Posted: | August 29, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Selinexor KPT-330 Multiple Myeloma non-Hodgkin Lymphoma Chronic Lymphocytic Leukemia |
Waldenström's macroglobulinemia Peripheral T-Cell Lymphoma Cutaneous T-Cell Lymphoma Chronic Myelocytic Leukemia Acute Lymphoblastic Leukemia |
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases |