Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer; Rectal Cancer; Colorectal Cancer; Colorectal Carcinoma; Breast Neoplasms; Colon Cancer; Colorectal Neoplasms

• Registration Number: NCT00041652
• Lead Sponsor: Gilead Sciences

Brief Summary

The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02
• Study First Submitted: 2002-07-11
• Study First Submitted QC: 2002-07-12
• Study First Posted: 2002-07-15
• Study Completion: 2003-06
• Status Verified: 2005-10
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
• Hematopoietic: WBC >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, CEA < 300 ng/mL
• Hepatic: Serum bilirubin </= 2.0 mg/dL, ALT < 2.5 x IULN
• Cardiovascular: Patients with LVEF >/= 40% by required MUGA/2D-ECHO study.
• Pulmonary: Patients with FEV1 >/= 60% by required Pulmonary Function Tests
• Other: Patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent. Patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Hoag Cancer Center; 🇺🇸 Newport Beach, California, United States