A Study of SGN-40 in Combination With Rituximab in Patients With CD20-Positive, Follicular and Marginal Zone B-Cell Non-Hodgkin's Lymphoma - Full Text View

Sponsor:	Genentech
Collaborator:	Seattle Genetics, Inc.
Information provided by (Responsible Party):	Genentech
ClinicalTrials.gov Identifier:	NCT00556699

Purpose

This is an open-label, multicenter Phase Ib study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of SGN-40 when combined with rituximab in patients with relapsed CD20-positive, follicular or marginal zone NHL who have received at least one prior rituximab-containing regimen.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: rituximab Drug: SGN-40	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Phase Ib Study of the Safety, Pharmacokinetics, and Activity of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination With Rituximab in Patients With CD20-Positive, Follicular and Marginal Zone B-Cell Non-Hodgkin's Lymphoma Who Have Relapsed Following Previous Rituximab Therapy

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Dacetuzumab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in vital signs, physical examination findings, and clinical laboratory results [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Incidence, nature, and severity of adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Pharmacokinetic parameters [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Patient's best response as assessed by the investigator [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Event-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	December 2007
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: rituximab Escalating intravenous repeating dose Drug: SGN-40 Escalating intravenous repeating dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented history of histologically confirmed CD20-positive, follicular NHL or marginal zone NHL
At least one previous treatment with rituxan monotherapy or a rituximab-containing regimen
Measurable disease
Either fresh or archived tumor specimen must be available for central confirmation of diagnosis and correlative studies
Life expectancy of > 3 months
For patients of reproductive potential, use of a reliable means of contraception

Exclusion Criteria:

Chemotherapy or radiotherapy within 28 days of Day 1
Prior treatment with a monoclonal antibody directed against CD40
Radioimmunotherapy or immunotherapy with a monoclonal antibody other than rituximab within 3 months of Day 1
Prior treatment with an investigational drug within 28 days of Day 1
Prior allogeneic bone marrow transplant
Prior autologous hematopoietic stem cell transplant within 12 weeks of Day 1
Concurrent systemic corticosteroid therapy
Prior anaphylactoid or other serious reaction to rituximab that resulted in hospitalization or discontinuation of therapy, or both
Evidence of clinically detectable ascites on Day 1
Other invasive malignancies within 3 years prior to Day 1 except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, or other cancer of which the patient has been disease-free for at least 3 years
History or evidence on physical examination of CNS disease
Active infection requiring parenteral antibiotics within 14 days of Day 1
Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to Day 1
Pregnancy (positive pregnancy test) or lactation
Serious, nonhealing wound, ulcer, or bone fracture
Clinically significant cardiovascular disease, congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to Day 1. Grade II or greater peripheral vascular disease at study entry.
Known human immunodeficiency virus (HIV) infection
Known serious medical conditions, including cirrhosis, hepatitis C infection, and chronic obstructive or chronic restrictive pulmonary disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556699

Sponsors and Collaborators

Genentech

Seattle Genetics, Inc.

Investigators

Study Director:

Deborah Hurst, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT00556699 History of Changes
Other Study ID Numbers:	ACF4325g
Study First Received:	November 9, 2007
Last Updated:	November 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

NHL
Rituxan
anti-CD40

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 02, 2012