Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

286

Study ID:

NCT01607892

Recruitment Status:

Completed

Sponsor:

Karyopharm Therapeutics Inc

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There are 12 Locations for this study

See Locations Near You

Moffitt Cancer Center
Tampa Florida, 33612, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Weill Cornell Medical Center
New York New York, 10065, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
The Ohio State University
Columbus Ohio, 43210, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Tom Baker Cancer Centre
Calgary Alberta, T2W 4, Canada
Princess Margaret Hospital
Toronto Ontario, M5T 2, Canada
Rigshospitalet
Copenhagen , 2100, Denmark

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

286

Study ID:

NCT01607892

Recruitment Status:

Completed

Sponsor:


Karyopharm Therapeutics Inc

How clear is this clinincal trial information?

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