Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fostamatinib · 6 trials · 12 indications
The cumulative incidence of serious adverse events (SAEs) occurring through day 30 following the intervention. An SAE is defined by the International Conference on Harmonization (ICH) guidelines as any adverse event fulfilling at least one of the following criteria: Results in death; Is life threatening; Requires in-subject hospitalization or prolongation of an existing hospitalization; Results in persistent or significant disability/incapacity; Is considered an important medical event (or medically significant)
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to
Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline
Hemoglobin level of \> 10 g/dL and 2 g/dL higher than the baseline hemoglobin
Mean change from Baseline (Visit 2) of proteinuria as measured by the spot Protein-Creatinine Ratio (sPCR) at 24 weeks (Visit 9) for the ITT Population
Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Primary efficacy is based on Phase II patients only.
Proportion of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
| Arm | Type | Description |
|---|---|---|
| Fostamatinib (150 mg twice daily for 14 days) + Standard of Care | ACTIVE_COMPARATOR | Fostamatinib (150 mg twice daily for 14 days) + Standard of Care |
| Placebo (twice daily for 14 days) + Standard of Care | PLACEBO_COMPARATOR | Placebo (twice daily for 14 days) + Standard of Care |
| Standard of Care (SOC) + Placebo (BID for 14 Days) | PLACEBO_COMPARATOR | Participants randomized to this arm will receive standard of care (SOC) treatment plus placebo given twice daily for 14 days |
| Standard of Care (SOC) + Fostamatinib 150mg (BID for 14 Days) | EXPERIMENTAL | Participants randomized to this arm will receive standard of care (SOC) treatment plus fostamatinib 150mg given twice daily for 14 days |
| Open Label Fostamatinib | EXPERIMENTAL | Open label Fostamatinib 100mg dose adjusted by the Principal Investigator after week 1 |
| Fostamatinib 150 mg | EXPERIMENTAL | Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks |
| Fostamatinib 100 mg | ACTIVE_COMPARATOR | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo tablet twice daily by mouth, over the course of 24 weeks |
| fostamatinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Fostamatinib | DRUG | Fostamatinib (150 mg twice daily) for 14 days and Standard of Care |
| Placebo | DRUG | Placebo (twice daily) for 14 days and Standard of Care |
| Fostamatinib 150 mg bid | DRUG | Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed. |
| Fostamatinib 150 mg | DRUG | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks |
| Fostamatinib 100 mg | DRUG | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks |
Inclusion Criteria: * ≥18 years of age at screening. * The subject or a legally authorized representative has provided written informed consent. * Hospitalized COVID-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask...
Fostamatinib is an investigational small molecule kinase inhibitor being studied for multiple conditions, including IGA Nephropathy, Hidradenitis Suppurativa, Acute Respiratory Distress Syndrome, Lymphoma, Warm Antibody Autoimmune Hemolytic Anemia, and Covid19. It is being developed by Rigel Pharmaceuticals, Inc. (RIGL) and is currently in Phase 2 clinical trials.
Fostamatinib is a small molecule kinase inhibitor, belonging to the -tinib class of drugs. It works by inhibiting kinase enzymes, which play a role in cellular signaling pathways. By blocking these kinases, Fostamatinib aims to modulate immune responses and reduce inflammation in the conditions it is being studied for.
Fostamatinib is being developed by Rigel Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock ticker is RIGL. Rigel is conducting clinical trials to evaluate the safety and efficacy of Fostamatinib across various indications, including respiratory and autoimmune conditions.
Fostamatinib is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trials are evaluating its safety and efficacy in conditions such as Acute Respiratory Distress Syndrome and Hidradenitis Suppurativa.
Fostamatinib has been studied in several clinical trials. Completed trials include NCT00446095 for B-cell Lymphoma, NCT02612558 for Warm Antibody Autoimmune Hemolytic Anemia, and NCT05040698 for Hidradenitis Suppurativa. A Phase 2 trial, NCT06564207, is planned for Acute Respiratory Distress Syndrome but has not yet started recruiting.
Fostamatinib is also known as Fostamatinib in combination with chemotherapy, specifically with gemcitabine and nab-paclitaxel. This combination is being studied for certain cancer indications. The drug itself is the same active ingredient, but the combination regimen includes additional chemotherapy agents.