NCT00960557

Brief Summary

The purpose of this study is to determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

August 14, 2009

Last Update Submit

August 22, 2011

Conditions

Neoplasm Metastasis

Keywords

hepatic tumor burdenliver cancerliver carcinomacarcinomahepatic cancerhepatic carcinomaVDAVascular Disrupting Agent

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.

    6 Months

Secondary Outcomes (1)

  • To determine progression-free survival (PFS).

    6 Months

Study Arms (1)

Combretastatin A1 Diphosphate

EXPERIMENTAL
Drug: Combretastatin A1 Diphosphate (OXi4503)

Interventions

Combretastatin A1 Diphosphate (OXi4503)DRUG

OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle.

Combretastatin A1 Diphosphate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed carcinoma. Tumor must be relapsed or refractory to standard therapies, or have no acceptable standard therapy.
  • Measurable disease by RECIST criteria.
  • Subjects must be at least 28 days from other investigational therapy and at least 2 weeks after chemotherapy or radiation therapy.
  • Age 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of less than 1.
  • Life expectancy of greater than 12 weeks.
  • Hemoglobin greater than 10 g/dL.
  • Adequate hepatic function.
  • Adequate renal function.
  • Adequate bone marrow reserve.
  • Able to maintain potassium, calcium and magnesium levels within normal ranges.
  • Must be able to provide written informed consent.
  • All women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
  • WOCBP and fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days after the last dose of study medication.

You may not qualify if:

  • Uncontrolled CNS metastases.
  • No other active malignancies.
  • Poorly controlled hypertension.
  • Recent history of serious cardiovascular conditions.
  • Recent history of CVA, TIA, or intermittent claudication.
  • Current anticoagulation therapy.
  • History of cardiac arrhythmias.
  • Abnormal ECG findings.
  • Subjects who require concomitant medications which cause QTc prolongation.
  • Major surgery within 30 days of treatment, or minor surgery within 7 days of treatment.
  • Uncontrolled, clinically significant active infection.
  • Subjects who are pregnant or lactating.
  • Subjects with any other intercurrent medical condition.
  • Subjects with a history of solid organ transplant or bone marrow transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

OXiGENE Investigational Site

Westmead, New South Wales, 2145, Australia

Location

OXiGENE Investigational Site

South Brisbane, Queensland, 4101, Australia

Location

OXiGENE Investigational Site

Adelaide, South Australia, 5000, Australia

Location

OXiGENE Investigational Site

Bentleigh, Victoria, 3165, Australia

Location

Related Publications (1)

  • Giri P, Batra PJ, Kumari A, Hura N, Adhikary R, Acharya A, Guchhait SK, Panda D. Development of QTMP: A promising anticancer agent through NP-Privileged Motif-Driven structural modulation. Bioorg Med Chem. 2023 Nov 15;95:117489. doi: 10.1016/j.bmc.2023.117489. Epub 2023 Oct 5.

    PMID: 37816266DERIVED

MeSH Terms

Conditions

Neoplasm MetastasisLiver NeoplasmsCarcinoma, HepatocellularCarcinoma

Interventions

Oxi 4503

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesAdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Michael Brown, MD

    Royal Adelaide Hospital

    PRINCIPAL INVESTIGATOR

  • Jason Lickliter, MD

    Monash Medical Centre

    PRINCIPAL INVESTIGATOR

  • Paul Mainwaring, MD

    Mater Adult Hospital

    PRINCIPAL INVESTIGATOR

  • Michael Millward, MD

    Sir Charles Gairdner Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 18, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

AU(4)