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A Phase I Study of the Safety and Pharmacokinetics of Escalating Doses of AGS15E Given as Monotherapy in Subjects with Metastatic Urothelial Cancer

Conditions

Bladder

Trial Phase

Phase I

Trial Purpose and Description

Trial Purpose

The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at least one prior chemotherapy regimen for metastatic disease.


Participation Guidelines

Age:
Gender:

Eligibility Criteria

Inclusion Criteria:

  • Histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra).
  • Must have failed at least one prior chemotherapy regimen for metastatic disease and/or is unfit for cisplatin-based chemotherapy
  • Subjects must have measureable disease according to RECIST (version 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of &ge 3 months
  • Adequate hematologic function
  • Adequate renal function
  • Adequate liver function
  • Gamma GT &le 1.5 x ULN (upper limit of normal)
  • Lipase within the normal range
  • Amylase &le 1.5 x ULN

Exclusion Criteria:

  • Preexisting sensory neuropathy Grade &ge 2 or motor neuropathy Grade &ge 2
  • Uncontrolled central nervous system metastases
  • Use of any investigational drug within 14 days or 5 half-lives prior to the first dose of study drug Any anticancer therapy, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy or any other agents to treat cancer within 14 days prior to the first dose of study drug
  • Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
  • History of thromboembolic events and/or bleeding disorders &le 3 months (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) prior to the first dose of study drug
  • Positive Hepatitis B surface antigen test
  • Positive Hepatitis C antibody test
  • Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
  • History of a primary invasive malignancy not listed in the inclusion criteria, which has not been in remission for at least 3 years. The following are exempt from the 3 year limit:

    • Non-melanoma skin cancer
    • adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is undetectable
    • cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Pap smear and
    • definitively treated, stage I/II ER+ breast cancer
  • Active infection requiring treatment &le7 days before first dose of study drug
  • History of eye surgery within 6 months, presence of cataracts or other ocular disorders significantly affecting vision
  • Condition or situation which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study

Sponsor:
Agensys, Inc.
Dates:
05/14/2014
Last Updated:
Study HIC#:
1307012407