Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Irofulven · 1 trial · 1 indication
Objective response rate defined as complete response, partial response or stable disease \> 9 weeks according to RECIST 1.1 for patients with measurable disease and defined as stable disease \> 9 weeks according to Prostate Cancer Working Group 3 (PCWG3) for bone metastases
| Arm | Type | Description |
|---|---|---|
| Irofulven + Prednisolone 10mg | EXPERIMENTAL | Irofulven will be administered as an intravenous dose of 0.45 mg/kg, over a 30-minute infusion period by venous access at day 1 and 8 of a three week cycle. Irofulven will be administered in combination with a daily dose of 10 mg orally administered prednisolone. |
| Name | Type | Description |
|---|---|---|
| Irofulven | DRUG | Irofulven will be administered as an intravenous dose of 0.45 mg/kg, over a 30-minute infusion period by venous access at day 1 and 8 of a three week cycle. Irofulven will be administered in combination with a daily dose of 10 mg orally administered prednisolone. |
| Prednisolone 10 mg | COMBINATION_PRODUCT | Irofulven will be administered as an intravenous dose of 0.45 mg/kg, over a 30-minute infusion period by venous access at day 1 and 8 of a three week cycle. Irofulven will be administered in combination with a daily dose of 10 mg orally administered prednisolone. |
Inclusion Criteria: * Have a histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate (carcinomas with pure small-cell histology or pure high grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed) * Surgically or medically castrated...
Irofulven is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have previously been treated with androgen receptor-targeted therapy and docetaxel. It is currently in Phase 2 clinical development.
Irofulven is being developed by Allarity Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ALLR.
Irofulven is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed.
Irofulven has been studied in a completed Phase 2 clinical trial with the identifier NCT03643107. The trial enrolled 15 male patients with metastatic castration-resistant prostate cancer who had been previously treated with AR-targeted therapy and docetaxel. The trial was conducted in Denmark.
Irofulven is also known by its chemical name and is sometimes referred to as 6-hydroxymethylacylfulvene. In clinical research, it is identified by the trial number NCT03643107.