Trial Search Results

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

This is a first-in-human study to evaluate the safety and anticancer activity of AGS67E. If results are encouraging, study will lead to development of a novel therapy regimen for patients who have not responded to the current standard of care.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Astellas Pharma Global Development, Inc.

Intervention(s):

  • Drug: AGS67E

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - Refractory or relapsed chronic lymphocytic leukemia (CLL), prolymphocytic leukemia
   (PLL), hairy cell leukemia (HCL) or non-Hodgkin lymphoma (NHL) (including those of T
   cell origin)

   - Eastern Cooperative Oncology Group performance score (ECOG) ≤ 2

   - Negative pregnancy test (women of childbearing potential)

   - Hematologic function, as follows (no platelet transfusion within 2 weeks and no RBC
   transfusion within 4 days before the first dose of study drug)

      - Absolute neutrophil count (ANC) ≥ 1,000/μL

      - Platelets ≥ 75,000/μL

      - Hemoglobin ≥ 8 g/dL (may be transfused ≥ 5 days)

   - Renal function: serum creatinine ≤ 2.0 mg/dL and estimated creatinine clearance of ≥
   45 mL/min by the Cockcroft-Gault equation

   - Direct bilirubin ≤ 1.5 x upper limit of normal (ULN)

   - Serum albumin ≥ 2.5 g/dL

   - Aspartate aminotransferase (AST) ≤ 1.5 x ULN unless there is hepatic involvement, then
   3 x ULN

   - Alanine aminotransferase (ALT) ≤ 1.5 x ULN unless there is hepatic involvement, then 3
   x ULN

   - Sexually active fertile subjects, and their partners, must agree to use medically
   accepted double-barrier methods of contraception (e.g., barrier methods, including
   male condom, female condom, or diaphragm with spermicidal gel) during the study and at
   least 6 weeks after termination of study therapy

Exclusion Criteria:

   - Preexisting sensory and/or motor neuropathy Grade ≥ 2

   - Small molecule therapy, radiotherapy, immunotherapy, monoclonal antibodies, or
   chemotherapy within 2 weeks before first dose of study drug

   - Radioimmunotherapy within 4 weeks before first dose of study drug

   - Use of any investigational drug (including marketed drugs not approved for this
   indication) within 14 days prior to the first dose of study drug

   - Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 2 weeks before the
   first dose of study drug (See Appendix F for list of excluded drugs)

   - Anti Graft-Versus-Host Disease (GVHD) therapy within 12 weeks before the first dose of
   study drug

   - Platelet transfusion within 2 weeks and RBC transfusion within 4 days before the first
   dose of study drug

   - Known central nervous system (CNS) disease

   - History of other primary malignancy (including myeloid malignancy, e.g.,
   myelodysplastic syndrome), unless

      - Curatively resected nonmelanomatous skin cancer

      - Other malignancy curatively treated with no known active disease present and no
      systemic treatment administered for 3 years before the first dose of study drug

   - Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart
   Association CHF Functional Classification System) or clinically significant cardiac
   disease within 12 months of the first dose of study drug, including myocardial
   infarction, unstable angina, Grade 2 or greater peripheral vascular disease,
   congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by
   outpatient medication

   - Women who are pregnant or lactating

   - Known HIV positive or AIDS

   - Positive Hepatitis B surface antigen test

   - Decompensated liver disease as evidenced by clinically significant ascites refractory
   to diuretic therapy, hepatic encephalopathy, or coagulopathy

   - Known sensitivity to any of the components of the investigational product AGS67E:

      - AGS67E

      - L-Histidine

      - α-trehalose dihydrate or

      - polysorbate 20

   - History of thromboembolic events (e.g., deep vein thrombosis (DVT) or pulmonary
   embolism (PE)) ≤ 2 weeks before the first dose of study drug and/or clinical diffuse
   intravascular coagulation (DIC)

   - Active infection requiring treatment ≤7 days before the first dose of study drug

   - Condition or situation which may put the subject at significant risk, may confound the
   study results, or may interfere significantly with subject's participation in the
   study

   - Any medical, psychiatric, addictive or other disorder which compromises the ability of
   the subject to give written informed consent and/or to comply with procedures.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting