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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01607892
First received: May 16, 2012
Last updated: August 23, 2016
Last verified: August 2016

May 16, 2012
August 23, 2016
June 2012
June 2016   (final data collection date for primary outcome measure)
Number of participants with Adverse Events [ Time Frame: 2 and 12 months ] [ Designated as safety issue: Yes ]
Severity of Adverse Events
Same as current
Complete list of historical versions of study NCT01607892 on ClinicalTrials.gov Archive Site
Area under the plasma concentration versus time curve (AUC) of KPT-330 [ Time Frame: 2 and 12 months ] [ Designated as safety issue: No ]
Changes in AUC over time
Same as current
Not Provided
Not Provided
 
Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer
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 are to find out more information such as: the highest dose of KPT-330 that can be given safely, the side effects it may cause, to examine how the body affects the study drug concentrations in the blood (pharmacokinetics or PK), to examine the effects of this study drug on the body (pharmacodynamics or PDn) and to gain some information on its effectiveness in treating cancer.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hematological Malignancies
Drug: KPT-330
Other Name: Selinexor
Experimental: selinexor
Intervention: Drug: KPT-330
Schmidt J, Braggio E, Kortuem KM, Egan JB, Zhu YX, Xin CS, Tiedemann RE, Palmer SE, Garbitt VM, McCauley D, Kauffman M, Shacham S, Chesi M, Bergsagel PL, Stewart AK. Genome-wide studies in multiple myeloma identify XPO1/CRM1 as a critical target validated using the selective nuclear export inhibitor KPT-276. Leukemia. 2013 Dec;27(12):2357-65. doi: 10.1038/leu.2013.172. Epub 2013 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
285
December 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Malignancies that are refractory to or who are intolerant of established therapy known to provide clinical benefit for their condition. Patients must not be candidates for anti-tumor regimens known to provide clinical benefit
  2. All patients on this study 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 all inclusion/exclusion criteria are 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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark
 
NCT01607892
KCP-330-001
No
Yes
Not Provided
Karyopharm Therapeutics, Inc
Karyopharm Therapeutics, Inc
Not Provided
Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics, Inc
Karyopharm Therapeutics, Inc
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP