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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT01607892
First received: May 16, 2012
Last updated: May 25, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Hematological Malignancies Drug: KPT-330 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Karyopharm Therapeutics Inc:

Primary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: 2 and 12 months ]
    Severity of Adverse Events


Secondary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of KPT-330 [ Time Frame: 2 and 12 months ]
    Changes in AUC over time


Enrollment: 285
Study Start Date: June 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: selinexor Drug: KPT-330
Other Name: Selinexor

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607892

Locations
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
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics Inc
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT01607892     History of Changes
Other Study ID Numbers: KCP-330-001
Study First Received: May 16, 2012
Last Updated: May 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Karyopharm Therapeutics Inc:
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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 19, 2017