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Also known as Milciclib maleate, PHA-848125AC
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, the most common form of liver cancer. It has been evaluated in patients with unresectable or metastatic hepatocellular carcinoma. Milciclib is not yet approved for any indication and remains in clinical development.
Milciclib is a small molecule inhibitor that targets CDK1, CDK2, CDK4, and NTRK1. By inhibiting these cyclin-dependent kinases and the NTRK1 receptor, it is designed to interfere with cell cycle progression and tumor cell proliferation in hepatocellular carcinoma.
Milciclib is being developed by Tiziana Life Sciences Ltd, which trades under the ticker TLSA. The company is the sponsor of the clinical program evaluating milciclib in hepatocellular carcinoma.
Milciclib is in Phase 2 clinical development. It has not been approved by the FDA or any regulatory agency and is considered an investigational agent. The Phase 2 program has focused on patients with unresectable or metastatic hepatocellular carcinoma.
Milciclib has been studied in the Phase 2 trial NCT03109886, titled Study of Milciclib in Patients With Unresectable/Metastatic Hepatocellular Carcinoma. The trial enrolled 31 patients across Greece, Israel, and Italy and is now completed. No active trials are currently listed for milciclib.
Milciclib maleate is an alternative name for milciclib. The maleate refers to the salt form of the same active small molecule. Both names refer to the CDK and NTRK1 inhibitor being developed by Tiziana Life Sciences for hepatocellular carcinoma.