Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fostamatinib · 1 trial · 1 indication
Minimum safe and biologically effective dose will be determined by dose limiting toxicities and overall response rate of the combination regimen, as well as pharmacokinetic and pharmacodynamic markers of fostamatinib (if available)
| Arm | Type | Description |
|---|---|---|
| Dose escalation phase: Dose level 0 | EXPERIMENTAL | Fostamatinib at dose level 0 (dose of 50mg QAM) in combination with standard of care ruxolitinib 10mg BID |
| Dose escalation phase: Dose level 1 | EXPERIMENTAL | Fostamatinib at dose level 1 (dose of 100mg QAM) in combination with standard of care ruxolitinib 10mg BID |
| Dose escalation phase: Dose level 2 | EXPERIMENTAL | Fostamatinib at dose level 2 (dose of 150mg QAM) in combination with standard of care ruxolitinib 10mg BID |
| Dose escalation phase: Dose level 3 | EXPERIMENTAL | Fostamatinib at dose level 3 (dose of 100mg BID) in combination with standard of care ruxolitinib 10mg BID |
| Candidate Dose #1 | EXPERIMENTAL | In the safety expansion cohort, subjects will be randomized to one of two candidate doses of fostamatinib (identified from the dose escalation phase) in combination with ruxolitinib 10mg BID. |
| Candidate Dose #2 | EXPERIMENTAL | In the safety expansion cohort, subjects will be randomized to one of two candidate doses of fostamatinib (identified from the dose escalation phase) in combination with ruxolitinib 10mg BID. |
| Name | Type | Description |
|---|---|---|
| Fostamatinib | DRUG | Fostamatinib will be administered as part of the initial dose escalation cohort and then two candidate doses will be identified to be administered for the safety expansion cohort. |
| Ruxolitinib | DRUG | Ruxolitinib 10mg BID will be administered in combination with Fostamatinib in each of the study arms. |
Inclusion Criteria 1. Patient is able and willing to provide written informed consent prior to any study related screening procedures are performed. 2. Age ≥ 18 years old at the time of informed consent 3. Have undergone allogeneic hematopoietic cell transplantation (HCT) from any donor source (mat...
Fostamatinib is being studied for the treatment of Chronic Graft Versus Host Disease (cGvHD). It is currently in Phase 1 clinical development as an investigational therapy for this condition. The drug is being evaluated in combination with ruxolitinib for patients with steroid refractory cGvHD.
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. This mechanism is being explored for its potential to treat Chronic Graft Versus Host Disease.
Fostamatinib is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting clinical trials to evaluate the drug for the treatment of Chronic Graft Versus Host Disease.
Fostamatinib is in Phase 1 clinical development for Chronic Graft Versus Host Disease. It is an investigational drug and has not been approved by the FDA for this indication. The ongoing Phase 1 trial is currently recruiting participants in the United States.
Fostamatinib is being studied in a Phase 1 clinical trial with the identifier NCT06233110. The trial is titled 'Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD' and is recruiting 30 participants aged 18 years and older in the United States. The study is controlled but not randomized or double-blind.