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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:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00320827
First received: April 28, 2006
Last updated: September 10, 2007
Last verified: September 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320827

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

No publications provided

ClinicalTrials.gov Identifier: NCT00320827     History of Changes
Other Study ID Numbers: CS1008-A-U101
Study First Received: April 28, 2006
Last Updated: September 10, 2007
Health Authority: United States: Food and Drug Administration

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014