Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma

Novartis

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Patupilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00273312

CEPO906A2213

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Patupilone

Experimental group

Description:

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

Treatment:

Drug: Patupilone