NCT00041652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline
Completed

Started Feb 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2002

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

August 19, 2021

Status Verified

October 1, 2005

First QC Date

July 11, 2002

Last Update Submit

August 12, 2021

Conditions

Colorectal CancerColon CancerRectal CancerColorectal NeoplasmsColorectal CarcinomaBreast CancerBreast Neoplasms

Keywords

Colorectal CancerColon CancerRectal CancerColorectal NeoplasmsColorectal CarcinomaBreast CancerBreast Neoplasms

Interventions

hMN14 (labetuzumab)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoag Cancer Center

Newport Beach, California, 92658, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal NeoplasmsBreast Neoplasms

Interventions

labetuzumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Terence Rugg, MD

    Gilead Sciences

    STUDY DIRECTOR

  • Lauri Welles, MD

    Gilead Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2002

First Posted

July 15, 2002

Study Start

February 1, 2000

Study Completion

June 1, 2003

Last Updated

August 19, 2021

Record last verified: 2005-10

Locations

US(1)