A Phase II, Open-Label, Efficacy and Safety, Ascending Dose, Pilot Study of be Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura
Latest Information Update: 14 Jun 2016
At a glance
- Drugs Fostamatinib (Primary)
- Indications Idiopathic thrombocytopenic purpura
- Focus Therapeutic Use
- Sponsors AstraZeneca; Rigel Pharmaceuticals
- 19 Dec 2013 New trial record
Most Recent Events
Trial Overview
Purpose
This trial investigated the efficacy and tolerability of ascending fostamatinib [R 935788] doses in patients with adult refractory immune thrombocytopenic purpura.
Primary Endpoints
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2
[ Time Frame: 2 weeks ] [ Designated as safety issue: No]
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6
[ Time Frame: 6 Weeks ] [ Designated as safety issue: No]
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12
[ Time Frame: 12 Weeks ] [ Designated as safety issue: No]
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24
[ Time Frame: 24 Weeks ] [ Designated as safety issue: No]
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12
[ Time Frame: 12 Months ] [ Designated as safety issue: No]
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24
[ Time Frame: 24 Months ] [ Designated as safety issue: No]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
Idiopathic thrombocytopenic purpura | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 18
Actual: 18
- Sex male & female
- Age Group 18-75 years; adult; elderly
Patient Inclusion Criteria
Patients must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form prior to admission to this study. Patients may be male or female, between the ages of 18 75. Men, if sexually active, must agree to use at least one medically acceptable form of birth control. Women of childbearing potential must have a negative urine pregnancy test, and agree to use two independent methods of birth control, if sexually active. Patients must have a diagnosis of chronic refractory ITP for at least 3 months. Chronic refractory ITP is defined as: 1. Platelet count less than 30,000/mm3 consistently for 3 months (except for transient nonsustained responses to various therapeutic regimens). There must be at least three separate platelet counts (below 30,000/mm3) over this period, with at least one extending back to three months or more prior to patient entry into the study. 2. The following conditions will have been excluded either by history or appropriate laboratory investigation: HIV infection (see below), lymphoproliferative disorders, myelodysplasia, SLE, drug-induced or alloimmune thrombocytopenia, or dysglobulinemias. 3. The patient must have tried at least two typical regimens for the treatment of ITP (George et al., Blood, 1996; Practice Guidelines, American Society of Hematology). At least 50% of the enrolled patients will not be known to be refractory to IVIg. Patients may or may not have been treated with IVIg in the past. Subjects must test negative for HIV, HBV, and HCV by standard serologic tests within the previous six months.
Patient Exclusion Criteria
Patients who have a history or presence of substantial or clinically significant respiratory, gastrointestinal, renal, hepatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorders that, in the Investigator's opinion, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug are excluded. Specifically excluded are lymphoma/chronic lymphocytic leukemia, hepatitis, or HIV associated with ITP. - Patients who have a history of relevant drug hypersensitivity are excluded. - Patients who have a history of substance abuse, drug addiction or alcoholism are excluded. Patients with the following laboratory abnormalities: a leukocyte count less than 2,500/mm3, a neutrophil count of less than 1,800/mm3, lymphocyte count less than 750/mm3, Hgb less than 10 g/L, or transaminase levels (ALT, AST) greater than 1.5xULN are excluded.
Trial Details
Identifiers
Identifier | Owner |
---|---|
D4300C00022 | AstraZeneca |
NCT00706342 | ClinicalTrials.gov: US National Institutes of Health |
C935788-007 | - |
Organisations
- Sponsors AstraZeneca; Rigel Pharmaceuticals
- Affiliations AstraZeneca; Rigel Pharmaceuticals
Trial Dates
-
Initiation Dates
Actual : 01 Jan 2007
-
Primary Completion Dates
Actual : 01 Apr 2010
-
End Dates
Actual : 01 Apr 2010
Other Details
- Design multicentre; open; prospective
- Phase of Trial Phase II
- Location USA
- Focus Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
FostamatinibPrimary Drug | Oral | Tablet |
Fostamatinib
Fostamatinib (Route: PO; Formulation: tablet; Company: AstraZeneca; Ascending doses. After 24 months of treatment, patients who continue to demonstrate a sustained response, in the investigator's judgment, will be offered the opportunity to receive ongoing therapy.)
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Jeffrey Skolnik, MD | AstraZeneca |
-
|
Skolnik J | AstraZeneca |
-
|
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- | Cleveland, Ohio | USA |
- | New York, New York | USA |
AstraZeneca |
-
|
-
|
AstraZeneca |
-
|
-
|
Trial History
Event Date | Event Type | Comment |
---|---|---|
14 Jun 2016 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 14 Jun 2016 |
10 Jan 2014 | Other trial event | Results have been published in Blood (volume 113, number 14), according to a Rigel Pharmaceuticals media release. Updated 14 Mar 2014 |
19 Dec 2013 | New trial record | New trial record Updated 19 Dec 2013 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Rigel Pharmaceuticals Inc. Rigel Will Present Clinical Product Portfolio Update at J.P. Morgan Healthcare Conference. Media-Rel 2014;.
Media Release
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