Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00273312

Collaborator

(none)

Enrollment

Locations

Arm

3.6

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Patupilone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Phase II Trial of Patupilone (EPO906) as Monotherapy to Evaluate Activity of Patupilone in Patients With Advanced Unresectable and/or Metastatic Hepatocellular Carcinoma (HCC)

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Oct 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patupilone was administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks	Drug: Patupilone Patupilone was in dosage strength of 10 mg/4 mL as a clear, colorless concentrate for solution for injection in individual 10 mL glass vials Other Names: EPO906

Arm

Intervention/Treatment

Experimental: Patupilone

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

Drug: Patupilone

Patupilone was in dosage strength of 10 mg/4 mL as a clear, colorless concentrate for solution for injection in individual 10 mL glass vials

Other Names:

EPO906

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Hepatocellular carcinoma patients with at least 1 previously un-irradiated, measurable lesion without any systemic single agent or combination chemotherapy. Previous local therapy is allowed.

Exclusion criteria:

Additional protocol-defined inclusion/exclusion criteria apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	San Francisco	California	United States	94115
2	Novartis Investigative Site	Hong Kong	Shatin, NT	Hong Kong
3	Novartis Investigative Site	Hong Kong		Hong Kong
4	Novartis Investigative Site	Seoul	Korea	Korea, Republic of	110 744
5	Novartis Investigative Site	Seoul		Korea, Republic of	738-736
6	Novartis Investigative Site	Taipei	Taiwan ROC	Taiwan	100
7	Novartis Investigative Site	Tai Chung Municipality		Taiwan