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Study of CS-1008 in Patients With Advanced Solid Malignancies and Lymphomas (Without Leukemic Component)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320827
First Posted: May 3, 2006
Last Update Posted: September 11, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Daiichi Sankyo, Inc.
  Purpose
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.

Condition Intervention Phase
Malignancies Lymphoma Drug: CS-1008 (humanized anti-DR5 antibody) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of CS-1008, a Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), Administered Weekly to Patients With Advanced Solid Malignancies and Lymphomas (Without Leukemic Component)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • To determine the recommended Phase 2 dose

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320827


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00320827     History of Changes
Other Study ID Numbers: CS1008-A-U101
First Submitted: April 28, 2006
First Posted: May 3, 2006
Last Update Posted: September 11, 2007
Last Verified: September 2007

Keywords provided by Daiichi Sankyo, Inc.:
Apoptosis
Death receptor 5
Cancer
Advanced solid malignancies and lymphomas (without leukemic component)

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs