A Phase 2 interventional study of Fostamatinib Disodium in T Cell Lymphoma, sponsored by Rigel Pharmaceuticals. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-19.
Sponsored by Rigel Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 18 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
Drug: Fostamatinib Disodium
200 mg PO BID
Also known as: Code Designation: R935788 Sodium Hexahydrate, USAN Name: Fostamatinib Disodium, CAS No.: 914295-16-2
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).
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.
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).
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)
Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR).
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)
Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug.
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.
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)
A total of 18 patients with T-Cell lymphoid malignancy were enrolled in this study from 05 March 2009 until 04 January 2010. As of 19 May 2010, no patients remain on study. All enrolled patients received at least one dose of fostamatinib. This study was conducted at 9 sites in the U.S. and Canada.
| Milestone | Overall Study |
|---|---|
| Started | 18 |
| Completed | 16 |
| Not completed | 2 |
| Withdrew: Ongoing | 2 |
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.
| Participants | Overall Study |
|---|---|
| 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). | 4 |
Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
| Participants | Overall Study |
|---|---|
| Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD). | 5 |
Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR).
| Participants | Overall Study |
|---|---|
| Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR). | 0 |
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.
| Days | Overall Study |
|---|---|
| Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug. | NA ± NA |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Study | — | 11/18 (61.1%) | 18/18 (100%) |
| Event | Overall Study |
|---|---|
| VomitingGastrointestinal disorders | 2/18 |
| SepsisInfections and infestations | 2/18 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/18 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/18 |
| DysphagiaGastrointestinal disorders | 1/18 |
| MelaenaGastrointestinal disorders | 1/18 |
| PyrexiaGeneral disorders | 1/18 |
| Hepatic FailureHepatobiliary disorders | 1/18 |
| Lobar PneumoniaInfections and infestations | 1/18 |
| PneumoniaInfections and infestations | 1/18 |
| Event | Overall Study |
|---|---|
| FatigueGeneral disorders | 11/18 |
| PyrexiaGeneral disorders | 8/18 |
| NeutropeniaBlood and lymphatic system disorders | 7/18 |
| ThrombocytopeniaBlood and lymphatic system disorders | 7/18 |
| DiarrhoeaGastrointestinal disorders | 7/18 |
| NauseaGastrointestinal disorders | 7/18 |
| VomitingGastrointestinal disorders | 7/18 |
| ChillsGeneral disorders | 7/18 |
| Aspartate Aminotransferase IncreasedInjury, poisoning and procedural complications | 6/18 |
| White Blood Cell Count DecreasedInjury, poisoning and procedural complications | 5/18 |
| Age, Continuous(Years) | Overall Study |
|---|---|
| Mean | 68.5 ± 12 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 8 |
| Male | 10 |
| Race/Ethnicity, Customized(Participants) | Overall Study |
|---|---|
| Asian | 2 |
| White | 15 |
| Other - Unknown | 1 |
Plan to share: No
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Rigel Pharmaceuticals