A Multicenter, Open-Label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P) as Monotherapy in Subjects with Primary or Secondary Hepatic Tumour Burde

Phase 1

Completed

• Conditions: Carcinomas with Primary (Hepatocellular carcinoma) or Secondary Hepatic Tumour (carcinoma metastasis) Burden; Cancer - Liver

• Registration Number: ACTRN12609000253202
• Lead Sponsor: Clinical Network Services (CNS) Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1.Signed Informed Consent Form. 2.Histologically or cytologically confirmed carcinoma, including carcinoid. All subjects in phases 1b and 2 must have hepatic tumor burden; primary hepatocellular carcinoma (HCC), or secondary metastatic deposits. 3. Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) criteria a. Each subject must have a measurable hepatic lesion. b. Non-HCC subjects must have nonirradiated, measurable disease in the liver and an extrahepatic site. 4. Tumor must be relapsed or refractory to standard therapies, or have no acceptable standard therapy.

Exclusion Criteria

1.Uncontrolled Central Nervous System (CNS) metastases. 2. Prior treatment with a Vascular Disrupting Agent (VDA). 3. Subjects with history of prior malignancy except for curatively treated basal cell carcinoma of the skin; cervical intraepithelial neoplasia; or localized prostate cancer with a current prostate-specific antigen (PSA) < 4.0 mg/dL. Subjects with other curatively treated malignancies who have no evidence of metastatic disease and > 2-year disease-free interval may be entered after approval by the Medical Monitor. 4. Uncontrolled Hypertension (HTN), defined as Blood Pressure (BP) > 120/80 mm Hg, despite medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden. The assessments will include collection of adverse events [as per Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0], laboratory (blood)tests and physical examination.[At each clinic visit through-out the study];Primary Outcome 2: To determine the maximum tolerated dose of OXi4503, which will be the dose used in the phase 2 part of the study. The assessments will include collection of adverse events [as per Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0], laboratory (blood) tests and physical examination.[At each clinic visit through-out the study];Primary Outcome 3: To determine the Pharmacokinetic (PK) profile for OXi4503 and its major metabolites in subjects with hepatic tumor burden. The assessment will be by analysis of blood concentration levels.[At each clinic visit through-out the study]

Secondary Outcome Measures

Name	Time	Method
To determine progression-free survival (PFS)[At each clinic visit through-out the study];To determine the proportion (%) of subjects with stable disease (SD),[At each clinic visit through-out the study]