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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00320827
Other study ID # CS1008-A-U101
Secondary ID
Status Completed
Phase Phase 1
First received April 28, 2006
Last updated September 10, 2007

Study information

Verified date September 2007
Source Daiichi Sankyo Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
CS-1008 (humanized anti-DR5 antibody)


Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the recommended Phase 2 dose
Secondary To investigate the pharmacokinetics of CS-1008 administered weekly
Secondary To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies
Secondary To study potential biomarkers of CS-1008 activity
Secondary To make preliminary assessments of anti-tumor effects of CS-1008
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