Neoplasm MetastasisPhase 1OXi4503NCT00960557
Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden
A Phase 1 study testing Combretastatin A1 Diphosphate (OXi4503) in people with Neoplasm Metastasis, run by Mateon Therapeutics at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- Combretastatin A1 Diphosphate (OXi4503)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesAustralia
- Study dates
- Jul 2009to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
OXiGENE Investigational Site
Adelaide, South Australia, 5000
OXiGENE Investigational Site
Bentleigh, Victoria, 3165
OXiGENE Investigational Site
South Brisbane, Queensland, 4101
OXiGENE Investigational Site
Westmead, New South Wales, 2145
About this study
Official title: A Multicenter, Open-label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Primary or Secondary Hepatic Tumor Burden
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.
- Conditions
- Neoplasm Metastasis
- Being tested
- Combretastatin A1 Diphosphate (OXi4503)
- Keywords
- hepatic tumor burden, liver cancer, liver carcinoma, carcinoma, hepatic cancer, hepatic carcinoma, VDA, Vascular Disrupting Agent
- Medical subject headings
- Neoplasm Metastasis, Liver Neoplasms, Carcinoma, Hepatocellular, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combretastatin A1 Diphosphate (OXi4503)Drug
OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Combretastatin A1 Diphosphate | Experimental | Not described Receives: Drug: Combretastatin A1 Diphosphate (OXi4503) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.
Measured: 6 Months
Secondary outcomes (1)
To determine progression-free survival (PFS).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mateon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Brown, MD, Principal investigator, Royal Adelaide HospitalJason Lickliter, MD, Principal investigator, Monash Medical CentrePaul Mainwaring, MD, Principal investigator, Mater Adult HospitalMichael Millward, MD, Principal investigator, Sir Charles Gairdner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960557
- Sponsor's protocol ID
- OXC101-100
- Acronym
- OXi4503
- Status last verified
- Aug 2011
- First submitted
- 14 Aug 2009
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37816266
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Primary or Secondary Hepatic Tumor Burden
- ClinicalTrials.gov ID
- NCT00960557
- Acronym / sponsor ID
- OXi4503 / OXC101-100
- Conditions
- Neoplasm Metastasis
- Keywords
- hepatic tumor burden, liver cancer, liver carcinoma, carcinoma, hepatic cancer, hepatic carcinoma, VDA, Vascular Disrupting Agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mateon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combretastatin A1 Diphosphate | Experimental | Drug: Combretastatin A1 Diphosphate (OXi4503) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (14 listed)
- Uncontrolled CNS metastases.
- No other active malignancies.
- Poorly controlled hypertension.
- Recent history of serious cardiovascular conditions.
- Recent history of CVA, TIA, or intermittent claudication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combretastatin A1 Diphosphate (OXi4503)OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle. | Drug | Combretastatin A1 Diphosphate |
Primary outcome
To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.
Time frame: 6 Months
1 secondary outcome
To determine progression-free survival (PFS).
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
- Derived from this study: PubMed 37816266Giri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Brown, MD principal investigator
Royal Adelaide Hospital
Jason Lickliter, MD principal investigator
Monash Medical Centre
Paul Mainwaring, MD principal investigator
Mater Adult Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combretastatin A1 Diphosphate (OXi4503) in people with Neoplasm Metastasis, run by Mateon Therapeutics at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00960557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2011.