This trial is active, not recruiting.

Condition hematological malignancies
Treatment kpt-330
Phase phase 1
Target XPO1
Sponsor Karyopharm Therapeutics, Inc
Start date June 2012
End date June 2016
Trial size 285 participants
Trial identifier NCT01607892, KCP-330-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
kpt-330 Selinexor

Primary Outcomes

Number of participants with Adverse Events
time frame: 2 and 12 months

Secondary Outcomes

Area under the plasma concentration versus time curve (AUC) of KPT-330
time frame: 2 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Karyopharm Therapeutics, Inc.
Location data was received from the National Cancer Institute and was last updated in August 2016.