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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignancies, Lymphoma

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the recommended Phase 2 dose

Authority:

United States: Food and Drug Administration

Study ID:

CS1008-A-U101

NCT ID:

NCT00320827

Start Date:

Completion Date:

Related Keywords:

  • Malignancies
  • Lymphoma
  • Apoptosis
  • Death receptor 5
  • Cancer
  • Advanced solid malignancies and lymphomas (without leukemic component)
  • Neoplasms
  • Lymphoma

Name

Location

University of Alabama at Birmingham Birmingham, Alabama  35294-3300