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

Status:

COMPLETED

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

Lead Sponsor:

Daiichi Sankyo

Conditions:

Malignancies

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 ...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00320827

Last Update

September 11 2007

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