Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Patupilone

• Registration Number: NCT00273312
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the safety, efficacy, and activity of patupilone in patients with advanced unresectable and/or metastatic hepatocellular carcinoma based on tumor response using modified RECIST criteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-04
• Study First Posted: 2006-01-09
• Primary Completion: 2006-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patupilone	Patupilone	was administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks

Primary Outcome Measures

Name	Time	Method
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)	at screening and at completion of every 6 weeks prior to the next dose administration

Secondary Outcome Measures

Name	Time	Method
Time to progression	at screening and at completion of every 6 weeks prior to the next dose administration
Overall survival	at screening and at completion of every 6 weeks prior to the next dose administration

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Tai Chung Municipality, Taiwan