A Phase I, Single Dose Escalating Study to Investigate the Tolerability, Pharmacokinetics and Dosimetry of 90 Y-Humanized MN-14 IgG in Colorectal Cancer Patients With Limited Residual Disease After Primary or Salvage Surgery

Gilead Sciences2 sites in 1 country30 target enrollmentJuly 15, 2002

ConditionsColorectal Neoplasms

DrugshMN14 (labetuzumab)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Colorectal Neoplasms
Sponsor: Gilead Sciences
Enrollment: 30
Locations: 2
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of residual colorectal cancer following recent surgery.

Registry

clinicaltrials.gov

Start Date

July 15, 2002

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gilead Sciences

Eligibility Criteria

Inclusion Criteria

•Performance Status: Patients with Karnofsky performance status \> 70%
•Hematopoietic: ANC \>/= 1.5 x 10/L; Hemoglobin \>/= 10 g/dL; Platelets \>/= 100 x 10/L
•Renal: Serum Creatinine \</= 1.5 x ULN
•Hepatic: Serum Bilirubin \</= 1.5 ULN; AST and ALT \</= 2.5 x ULN; Alk Phosphatase \</= 2.5 x ULN
•Cardiovascular: Patients with LVEF \>/= 50% by required MUGA/2D-ECHO tests
•Pulmonary: Patients with DF and FEV1 \>/= 60% by required Pulmonary Function Tests
•Central Nervous System: Patients with known metastatic disease to the CNS are excluded.
•Other: Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into study. Patients must understand and give written informed consent.