Solid TumorsPhase 1NCT00977210
Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors
A Phase 1 study testing OXi4503 in people with Solid Tumors, run by Mateon Therapeutics at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly infusions to patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- OXi4503
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2005to Sep 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 proven cancer.
- Written informed consent.
- Age >/= 18 years.
- Life expectancy of at least 12 weeks.
- World Health Organization (WHO) performance status of 0 or 1.
- Adequate Hematological and biochemical indices to support investigational therapy.
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- 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.
- Measurable and evaluable disease.
- All toxic manifestations of previous treatment must have resolved.
- Able to undergo MRI scanning.
Who cannot join
- Radiotherapy, endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) prior to treatment.
- Pregnant and lactating women.
- Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
- Patients which have active uncontrolled infections.
- Patients with any other condition that in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
- Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
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- Previous or ongoing cardiac conditions.
- Uncontrolled hypertension.
- Patients taking any drug known to prolong the QTc interval.
- Patients who have had any ischaemic or vascular damage from previous radiotherapy.
- Patients taking warfarin or heparin.
- Patients taking naproxen.
- Patients taking supplements or multivitamins containing vitamin C.
- Patients should not be taking any other investigational drug for the duration of the study.
- Patients with brain metastases or neurological tissue involvement of the spinal column.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
CRUK Investigational Site
Manchester
CRUK Investigational Site
Middlesex
About this study
Official title: A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.
The purpose of this study is to establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly infusions to patients with advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- OXi4503
- Keywords
- Phase 1, oxi4503, oxigene, cruk, solid tumors, VDA, vascular disrupting agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXi4503Drug
OXi4503 will be administered weekly for 3 weeks followed by a week with no treatment. The starting dose will be 0.06 mg/m2 given as an intravenous infusion over 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| OXi4503 | Experimental | Not described Receives: Drug: OXi4503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.
Measured: 4 weeks
Secondary outcomes (1)
To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startJul 2005
- Primary completionSep 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 Solid TumorsStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mateon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977210
- Sponsor's protocol ID
- PH1/098
- Status last verified
- Oct 2011
- First submitted
- 14 Sep 2009
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Patterson DM, Zweifel M, Middleton MR, Price PM, Folkes LK, Stratford MR, Ross P, Halford S, Peters J, Balkissoon J, Chaplin DJ, Padhani AR, Rustin GJ. Phase I clinical and pharmacokinetic evaluation of the vascular-disrupting agent OXi4503 in patients with advanced solid tumors. Clin Cancer Res. 2012 Mar 1;18(5):1415-25. doi: 10.1158/1078-0432.CCR-11-2414. Epub 2012 Jan 10.
PubMed 22235096
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT00977210
- Acronym / sponsor ID
- PH1/098
- Conditions
- Solid Tumors
- Keywords
- Phase 1, oxi4503, oxigene, cruk, solid tumors, VDA, vascular disrupting agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mateon TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Research UK
- Study start
- Jul 2005
- Primary completion
- Sep 2010 (actual)
- First posted
- 15 Sep 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 establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly infusions to patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OXi4503 | Experimental | Drug: OXi4503 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven cancer.
- Written informed consent.
- Age >/= 18 years.
- Life expectancy of at least 12 weeks.
- World Health Organization (WHO) performance status of 0 or 1.
Key exclusion criteria (15 listed)
- Radiotherapy, endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) prior to treatment.
- Pregnant and lactating women.
- Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
- Patients which have active uncontrolled infections.
- Patients with any other condition that in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
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 |
|---|---|---|
| OXi4503OXi4503 will be administered weekly for 3 weeks followed by a week with no treatment. The starting dose will be 0.06 mg/m2 given as an intravenous infusion over 10 minutes. | Drug | OXi4503 |
Primary outcome
To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.
Time frame: 4 weeks
1 secondary outcome
To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503.
Time frame: 4 weeks
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 31 Oct 2011.
- Derived from this study: PubMed 22235096Patterson DM, Zweifel M, Middleton MR, Price PM, Folkes LK, Stratford MR, Ross P, Halford S, Peters J, Balkissoon J, Chaplin DJ, Padhani AR, Rustin GJ. Phase I clinical and pharmacokinetic evaluation of the vascular-disrupting agent OXi4503 in patients with advanced solid tumors. Clin Cancer Res. 2012 Mar 1;18(5):1415-25. doi: 10.1158/1078-0432.CCR-11-2414. Epub 2012 Jan 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 OXi4503 in people with Solid Tumors, run by Mateon Therapeutics at 2 sites in United Kingdom.
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 11 inclusion and 15 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 31 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions. (time frame: 4 weeks). 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 NCT00977210, 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 31 Oct 2011.