Clinical trial NCT00816686: A Phase 1 Study of the Safety and Pharmacokinetics of AGS-16M18 in Subjects With Advanced Renal Cell Cancer
Official title: A Phase 1, Open-Label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M18 Given as Monotherapy in Subjects With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Keywords: clinical trial, phase 1
carcinoma, advanced renal cell
kidney
pharmacokinetics
safety
AGS-16M18
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Agensys, Inc.
First posted: 2009-01-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first in human study of AGS-16M18 given every week to subjects with advanced renal cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days until the disease worsens.

Detailed description: Subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard, dose escalation study design. A disease assessment will be performed at study week 5 (+/- 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may receive AGS-16M18 extended therapy at the dose and schedule of their assigned cohort until disease progression or intolerability of AGS-16M18. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-16M18.

Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amendable to cure by surgery or other means, and must have failed at least one prior systemic therapy, including but not limited to treatment with sunitinib, temsirolimus or sorafenib
* Evaluable/Measureable disease according to Response Criteria for Solid tumors
* Eastern Cooperative Group performance status of 0-1
* Therapeutic anti-coagulation (PT, and/or INR, PTT) permitted, if clinically stable and \>/= 3 months from initiation

Exclusion Criteria:

* Past or present documented central nervous system (CNS) tumor or CNS metastasis
* Use of investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
* History of thromboembolic events and bleeding disorders \</= 3 months (e.g., DVT or PE)
* Major Surgery (that requires general anesthesia) within 4 weeks of study enrollment

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Throughout the treatment
measure: Assessment of PK variables
timeFrame: Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose
Secondary outcomes:
measure: Incidence of anti-AGS-16M18 antibody formation
timeFrame: Week 0, week 1, week 4, week 8, every 8 weeks during extension period, 2 and 3 months after last dose
measure: Changes in tumor status
timeFrame: Week 5, week 8, every 8 weeks during extension period
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
city: New York
country: United States
state: New York
Study officials:
affiliation: Agensys, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References: