NCT00556699

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2007

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 20, 2014

Status Verified

November 1, 2011

Enrollment Period

2.9 years

First QC Date

November 9, 2007

Last Update Submit

March 18, 2014

Conditions

Non-Hodgkin's Lymphoma

Keywords

NHLRituxananti-CD40

Outcome Measures

Primary Outcomes (1)

  • Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose

    Length of study

Secondary Outcomes (6)

  • Changes in vital signs, physical examination findings, and clinical laboratory results

    Length of study

  • Incidence, nature, and severity of adverse events

    Length of study

  • Pharmacokinetic parameters

    Length of study

  • Patient's best response as assessed by the investigator

    Length of study

  • Duration of response

    Length of study

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: rituximabDrug: SGN-40

Interventions

rituximabDRUG

Escalating intravenous repeating dose

1
SGN-40DRUG

Escalating intravenous repeating dose

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximabdacetuzumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Deborah Hurst, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2007

First Posted

November 12, 2007

Study Start

December 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 20, 2014

Record last verified: 2011-11