Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Milciclib · 1 trial · 1 indication
Overall safety profile, evaluated on the basis of laboratory (i.e. hematology and blood chemistry, urinalysis, vital signs, ophthalmologic examinations) and adverse events emerging during the trial, will be determined. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 will be used for the severity grading of adverse events and of hematological and blood chemistry abnormalities
| Arm | Type | Description |
|---|---|---|
| Milciclib maleate | EXPERIMENTAL | milciclib maleate ,10, 50 and 100 mg hard gelatine capsules , 100 mg once daily, for 4 consecutive days a week in a 4-week cycle (4 days on/3 days off x q4 wks) for a total of 12 weeks (i.e. 3 cycles) |
| Name | Type | Description |
|---|---|---|
| Milciclib maleate | DRUG | 100 mg/day once daily, for 4 consecutive days a week in a 4-week cycle (4 days on/3 days off x q4 wks) for a total of 12 weeks (i.e. 3 cycles) unless patient refusal, consent withdrawal, Investigator's decision, unacceptable toxicity or death whichever occurs earlier. After the completion of three cycles, patients who, in the Investigator's judgment, are benefiting from treatment with milciclib, will resume treatment and will remain on study up to Day 180 from treatment start, unless withdrawal criteria are met earlier. |
Inclusion Criteria: * Patients with diagnosis of HCC, confirmed by histology or radiology according to American Association for the Study of Liver Diseases/European Association for the Study of the Liver (AASLD/EASL) criteria prior to the start of the investigational product. Imaging characteristic...
Milciclib is an investigational small molecule being studied for the treatment of hepatocellular carcinoma, a type of liver cancer. It is currently in Phase 2 clinical development and has been evaluated in patients with unresectable or metastatic hepatocellular carcinoma.
Milciclib is being developed by Tiziana Life Sciences Ltd, a biopharmaceutical company traded on NASDAQ under the ticker symbol TLSA. The company is conducting clinical research to evaluate the drug's safety and efficacy in oncology.
Milciclib is in Phase 2 clinical development. It has completed one Phase 2 trial in hepatocellular carcinoma, and it remains an investigational drug that has not been approved by regulatory authorities.
Milciclib has been studied in a completed Phase 2 clinical trial with the identifier NCT03109886. This trial enrolled 31 patients with unresectable or metastatic hepatocellular carcinoma and was conducted in Greece, Israel, and Italy.
Milciclib is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for hepatocellular carcinoma. The completed trial NCT03109886 evaluated its use, but regulatory approval has not been granted.