NCT01301391

Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

Phase II Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tiziana Life Sciences LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy.

Detailed description

This is a single-arm, open-label, multicenter, phase II clinical trial design with an early stopping rules. PHA-848125AC will be administered to patients with recurrent metastatic unresectable B3 thymoma or thymic carcinoma who have received more than one line of prior systemic therapy for advanced / metastatic disease. The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of the patients. The primary end point for this study is a progression free survival rate of 3 months.

Conditions

• Malignant Thymoma

Interventions

Type	Name	Description
DRUG	Milciclib Maleate	150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.

Timeline

• Start date: 2011-02-02
• Primary completion: 2017-05-31
• Completion: 2018-12-17
• First posted: 2011-02-23
• Last updated: 2019-02-06
• Results posted: 2018-10-04

Locations

3 sites across 2 countries: United States, Italy