NCT00320827

Brief Summary

This is a dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six weeks and possibly up to 12 weeks depending on response.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
Last Updated

September 11, 2007

Status Verified

September 1, 2007

First QC Date

April 28, 2006

Last Update Submit

September 10, 2007

Conditions

MalignanciesLymphoma

Keywords

ApoptosisDeath receptor 5CancerAdvanced solid malignancies and lymphomas (without leukemic component)

Outcome Measures

Primary Outcomes (1)

  • To determine the recommended Phase 2 dose

Secondary Outcomes (4)

  • To investigate the pharmacokinetics of CS-1008 administered weekly

  • To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies

  • To study potential biomarkers of CS-1008 activity

  • To make preliminary assessments of anti-tumor effects of CS-1008

Interventions

CS-1008 (humanized anti-DR5 antibody)DRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically diagnosed metastatic solid tumors or lymphomas (with no leukemic component) which are refractory to, not curable with, or not eligible for standard treatment(s).
  • Eighteen years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2
  • Resolution of any toxic effects (except alopecia) of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 grade of equal to or less than 1
  • Men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter.
  • All female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to treatment
  • Patients must be fully informed about their illness and the investigational nature of the study protocol

You may not qualify if:

  • Anticipation of the need for a major surgical procedure or radiation therapy during the study
  • Treatment with chemotherapy, hormonal therapy, radiotherapy, major surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study enrollment
  • Cumulative radiation therapy to greater than 25% of the total bone marrow
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolytic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease \[COPD\] or asthma)
  • Patients with a clinically active brain metastasis (i.e., not treated or still requiring therapy with steroids or radiotherapy \[RT\]; or with progression 4 weeks after the completion of RT) or an uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
  • Clinically significant active infection which requires antibiotic therapy, or HIV-positive patients receiving antiretroviral therapy.
  • Chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

NeoplasmsLymphoma

Interventions

tigatuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

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

April 28, 2006

First Posted

May 3, 2006

Last Updated

September 11, 2007

Record last verified: 2007-09

Locations

US(1)