search
Back to results

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

Primary Purpose

Malignancies, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CS-1008 (humanized anti-DR5 antibody)
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignancies focused on measuring Apoptosis, Death receptor 5, Cancer, Advanced solid malignancies and lymphomas (without leukemic component)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Outcomes

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

Full Information

First Posted
April 28, 2006
Last Updated
September 10, 2007
Sponsor
Daiichi Sankyo, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00320827
Brief Title
Study of CS-1008 in Patients With Advanced Solid Malignancies and Lymphomas (Without Leukemic Component)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignancies, Lymphoma
Keywords
Apoptosis, Death receptor 5, Cancer, Advanced solid malignancies and lymphomas (without leukemic component)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CS-1008 (humanized anti-DR5 antibody)
Primary Outcome Measure Information:
Title
To determine the recommended Phase 2 dose
Secondary Outcome Measure Information:
Title
To investigate the pharmacokinetics of CS-1008 administered weekly
Title
To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies
Title
To study potential biomarkers of CS-1008 activity
Title
To make preliminary assessments of anti-tumor effects of CS-1008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs