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Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer

This study is currently recruiting participants.
Verified February 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01499303
First received: December 19, 2011
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large B-Cell Lymphoma (abbreviated as DLBCL)


Condition Intervention Phase
Diffuse Large B-Cell Lymphoma
 Drug: Fostamatinib
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma(DLBCL)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage patients with a complete response (CR)or partial response (PR) using the revised response criteria for malignant lymphoma (Cheson et al 2007) [ Time Frame: From randomization until disease progression (expected duration of treatment approximately 6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with at least one visit response of CR or PR using revised response criteria (Cheson et al 2007), who have a duration of response of at least 24 weeks. [ Time Frame: From week 8 after randomization until disease progression or discontinuation from study (expected duration of treatment: approximately 6 months) ] [ Designated as safety issue: No ]
  • Progression Free Survival as defined by the time from randomization until the date of objective relapse/progression or death. [ Time Frame: From week 8 after randomization until disease progression or discontinuation from study (expected duration of treatment: approximately 6 months) ] [ Designated as safety issue: No ]
    By any cause in the absence of relapse or progression regardless of whether the patient withdraws from randomized.

  • Duration of Response as defined by the time from the date of first documented response (CR or PR) until the date of documented relapse/progression or death [ Time Frame: From week 8 after randomization until disease progression or discontinuation from study (expected duration of treatment: approximately 6 months) ] [ Designated as safety issue: No ]
  • Percentage of patients with serious adverse events and adverse events. [ Time Frame: From randomization until discontinuation from study (expected duration of treatment: approximately 6 months) ] [ Designated as safety issue: Yes ]
  • Individual plasma clearance (Cl) [ Time Frame: Before dosing, and at 1, 2, 4 and 8 hours after dosing ] [ Designated as safety issue: No ]
  • Initial volume (VL) [ Time Frame: Before dosing, and at 1, 2, 4 and 8 hours after dosing. ] [ Designated as safety issue: No ]
  • Peripheral volume (VT) [ Time Frame: Before dosing, and at 1, 2, 4 and 8 hours after dosing. ] [ Designated as safety issue: No ]
  • Distributional clearance. [ Time Frame: Before dosing, and at 1, 2, 4 and 8 hours after dosing. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fostamatinib 200
200mg fostamatinib bid n=60
 Drug: Fostamatinib
Phase II Trial to evaluate the efficacy of 200mg fostamatinib

Detailed Description:

Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

  Eligibility

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

Inclusion Criteria:

  • Aged at least 18 years of age.
  • Patients with relapsed or refractory diffuse large B-cell lymphoma who have previously received R-CHOP (or equivalent) chemo-immunotherapy and high dose chemotherapy with stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue.
  • Measurable disease as defined by Cheson et al 2007 criteria.
  • One fresh pre-treatment excisional or core needle biopsy from suitable and accessible site.
  • World Health Organization (WHO) performance status 0 to 1.

Exclusion Criteria:

  • Treatment with nitrosurea, mitomycin C, investigational agents or study drugs w/in28 days of first dose of study treatment, any other chemotherapy, immunotherapy or anticancer agents w/in 3 weeks of first dose of study treatment, previous fostamatinib.
  • With the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
  • Uncontrolled hypertension (defined as >140mmHg systolic and/or > 90 mmHG diastolic at baseline with or without antihypertensive therapy.
  • Evidence of tuberculosis (TB).
  • Inadequate boen marrow reserve.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499303

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

  Show 20 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jeffrey Skolnik, MD Sponsor GmbH
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01499303     History of Changes
Other Study ID Numbers: D4302C00001
Study First Received: December 19, 2011
Last Updated: February 19, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
lymphoma
DLBCL
fostamatinib
Diffuse Large B-Cell Lymphoma (DLBCL)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 23, 2013