Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies
NCT ID: NCT00805467
Last Updated: 2014-06-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
624 participants
INTERVENTIONAL
2008-08-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
R935788 50 mg tablet, orally, twice-a-day
Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
2
R935788 100 mg tablet, orally, twice-a-day
Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
3
R935788 100 mg tablet, orally, once-a-day
Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
4
R935788 150 mg tablet, orally, once-a-day
Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
Interventions
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Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who are being treated in Study C-788-006X
* Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events
* Patients who withdrew from Study C-788-010 at Month 4 or Month 5 because of a pre-defined lack of efficacy
* Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative pregnancy test at the time of entry and at each laboratory determination.
Exclusion Criteria
1. unresolved Grade 2 or greater toxicity in a RA protocol studying R788
2. uncontrolled or poorly controlled hypertension;
3. recent (within past 2 months) serious surgery or infectious disease;
4. recent history (since enrollment in prior R788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;
5. known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;
6. interstitial pneumonitis or active pulmonary infection;
7. known laboratory abnormalities: ALT \> 1.2 x ULN, creatinine \>1.5x ULN, an ANC \<2,500/mm3 or 2.5 x 109/L, lymphocyte count \< 600/mm3 or 0.6 x 109L, Hgb \< 9 g/dL or 5 mmol/L, platelet count \<125,000/mm3 or 125 x 109/L are excluded.
* The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine = 3 oz or 89 mL; 80 proof distilled spirits = 1.5 oz or 44 mL.
* The patient is unable to report for clinical and laboratory monitoring as per protocol.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chris O'Brien, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
La Jolla, California, United States
Research Site
Palm Desert, California, United States
Research Site
Palo Alto, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Maria, California, United States
Research Site
Hamden, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Aventura, Florida, United States
Research Site
Boca Raton, Florida, United States
Research Site
Gainesville, Florida, United States
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Ocala, Florida, United States
Research Site
Orange Park, Florida, United States
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Orlando, Florida, United States
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South Miami, Florida, United States
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Venice, Florida, United States
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Boise, Idaho, United States
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Coeur d'Alene, Idaho, United States
Research Site
South Bend, Indiana, United States
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Elizabethtown, Kentucky, United States
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Cumberland, Maryland, United States
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Hagerstown, Maryland, United States
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Lansing, Michigan, United States
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Omaha, Nebraska, United States
Research Site
Roslyn, New York, United States
Research Site
Smithtown, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Mayfiled Village, Ohio, United States
Research Site
Erie, Pennsylvania, United States
Research Site
Willow Grove, Pennsylvania, United States
Research Site
Wyomissing, Pennsylvania, United States
Research Site
Jackson, Tennessee, United States
Research Site
Austin, Texas, United States
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San Antonio, Texas, United States
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Oklahoma City, Washington, United States
Research Site
Spokane, Washington, United States
Research Site
Antwerp, , Belgium
Research Site
Ghent, , Belgium
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Liège, , Belgium
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Medellín, , Colombia
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Bordeaux, , France
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Hamburg, , Germany
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Leipzig, , Germany
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Würzburg, , Germany
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Siena, , Italy
Research Site
Udine, , Italy
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Chihuahua City, , Mexico
Research Site
Cuernava, , Mexico
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Del. Cuauhtemoc, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
León, , Mexico
Research Site
Mexcio, , Mexico
Research Site
México, , Mexico
Research Site
Morelia, , Mexico
Research Site
San Luis Potosí City, , Mexico
Research Site
Jesus Maria, , Peru
Research Site
Lima, , Peru
Research Site
Bialystok, , Poland
Research Site
Bytom, , Poland
Research Site
Elblag, , Poland
Research Site
Grodzisk Mazowiecki, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Torun, , Poland
Research Site
Wroclaw, , Poland
Research Site
Zyrardów, , Poland
Research Site
Brailari, , Romania
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Sf. Gheorghe, , Romania
Research Site
Sibiu, , Romania
Countries
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Other Identifiers
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D4300C00021
Identifier Type: -
Identifier Source: secondary_id
C-935788-012
Identifier Type: -
Identifier Source: org_study_id
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