Clinical Trial: Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II, Multicenter, Simon Two-Stage Study of Fostamatinib Disodium in Patients With Relapsed or Refractory T-Cell Lymphoma

Brief Summary: Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol defined intervals.

Detailed Summary: Up to 61 patients (male and female) meeting the inclusion and exclusion criteria will be enrolled into this trial in two stages. All enrolled patients will be treated with R788 at 200 mg PO bid until disease progression. In the initial stage of the study, a total of 19 patients will be enrolled and treated with Fostamatinib Disodium. Should at least 4 patients exhibit a response at Week 8 or later of the study, the second stage of 36 patients will open to enrollment. Efficacy will be assessed by CT and PET scans (when indicated) and physical exam at baseline, and CT scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol-defined intervals. Patients with accessible tumor tissue will be asked to undergo a biopsy for a fresh tissue sample for assessment of Syk activity in tumor tissue. Archived tissue samples from the initial diagnostic biopsy and the most recent biopsy for lymphoma will be obtained in the event a fresh tumor biopsy cannot be obtained. Patients who have accessible tumor tissue will be asked to consent to a second tumor biopsy at Week 8, to assess the impact of Fostamatinib Disodium treatment on the activity of Syk and its downstream markers. All baseline fresh or archived tumor tissue samples will undergo central pathology review to confirm the diagnosis of TCL.
Sponsor: Rigel Pharmaceuticals

Current Primary Outcome: The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD). [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) ]

Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response.


Original Primary Outcome: The primary efficacy endpoint for this study is the overall response rate (ORR) [proportion of patients with best response of complete response (CR) or partial response (PR)]. [ Time Frame: 8 weeks ]

Current Secondary Outcome:

  • Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD). [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) ]
    Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
  • Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR). [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) ]
    Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR).
  • Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug. [ Time Frame: Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days) ]
    Duration of Overall Response is the time from first documentation of Complete or Partial Response (Cheson 2007), whichever occurs earlier, to discontinuation of study drug.


Original Secondary Outcome: The secondary efficacy endpoints include: Clinical benefit rate [proportion of patients with best response of CR, PR, or stable disease (SD)], progression free survival and duration of response [ Time Frame: 8 weeks ]

Information By: Rigel Pharmaceuticals

Dates:
Date Received: November 21, 2008
Date Started: March 2009
Date Completion:
Last Updated: August 9, 2016
Last Verified: August 2016