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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01499303
First received: December 19, 2011
Last updated: January 29, 2014
Last verified: January 2014
  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:


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 ]

Enrollment: 101
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499303

  Show 21 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: January 29, 2014
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 August 20, 2014