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 Burden

A Multicenter, Open-Label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P) when treated on Days 1, 8 and 15 of a 28 day treatment cycle in escalating doses as Monotherapy in Subjects with Primary or Secondary Hepatic Tumour Burden until the maximum tolerated dose is determined.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000253202

Enrollment

Registered

2009-05-13

Start date

2009-03-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P)

Interventions

Subjects will be dosed in 28-day treatment cycles by IV infusion of Combretastatin A1 Diphosphate (OXi4503, CA1P). Subject will have up to 6 cycles of treatment. Dosing will commence at 8.5 mg/m2 and escalate to 11.0, 13.5 and 15.5 mg/m2 and then increase by an additional 25% of the preceding dose level thereafter.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results