Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer
Condition: Hematological Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Intervention: KPT-330
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 286.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

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.
    

Eligibility 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.