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: August 8, 2014
Last verified: August 2014

December 19, 2011
August 8, 2014
December 2011
October 2013   (final data collection date for primary outcome measure)
Objective Response Rate [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Patients were assessed using the revised response criteria for malignant lymphoma (Cheson). Patients were assessed for response, with CT and FDG-PET scans at 8 weeks, then every 12 weeks until radiological progression by clinical CT. Complete response (CR) was defined as disappearance of all target and non-target lesions in the liver and spleen and all lymph node masses regressed to normal size. Partial response (PR) was defined as ≥50% reduction in sum of the product of the diameters (SPD) for measured lymph nodes, splenic and liver lesions separately compared to baseline SPD. Objective response rate (CR + PR) analysis, exact binomial test, primary analysis.
Percentage of 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 or discontinuation from study (expected duration of treatment: approximately 6 months) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01499303 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 reponse 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 ]
Not Provided
Not Provided
 
Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer
Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma(DLBCL)

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)

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

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-Cell Lymphoma
Drug: Fostamatinib
Phase II Trial to evaluate the efficacy of 200mg fostamatinib
Experimental: Fostamatinib 200
200mg fostamatinib bid n=60
Intervention: Drug: Fostamatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01499303
D4302C00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Bernadette Weidman, RN, MSN, PMP Sponsor GmbH
AstraZeneca
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP