Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00022295
Phenoxodiol in Treating Patients With Refractory Solid Tumors
A Phase 1 study testing idronoxil in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Kazia Therapeutics Limited at 1 site in United States.
Trial summary
RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- idronoxil
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Oct 2007
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumor
- Refractory to standard therapy OR
- No standard therapy exists
- No breast cancer
- No active CNS metastases
- Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- WBC greater than 3,000/mm^3
- Neutrophil count greater than 1,500/mm^3
- Hemoglobin greater than 10 g/dL (9 g/dL for women)
Hepatic:
- Bilirubin less than 1.2 mg/dL
- Transaminases no greater than 3 times upper limit of normal
Renal:
- Creatinine no greater than 1.4 mg/dL
Other:
- No active infection
- No contraindication to the insertion of a vascular access device
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent systemic anticancer immunotherapy
Chemotherapy:
- No concurrent systemic anticancer chemotherapy
Endocrine therapy:
- No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists
Radiotherapy:
- See Disease Characteristics
- Concurrent localized radiotherapy for control of local disease complications allowed
Surgery:
- See Disease Characteristics
Other:
- Recovered from prior antineoplastic therapy
- At least 4 weeks since prior investigational agents
- No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients With Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors Are Refractory to Standard Therapy
RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
- Determine the steady-state pharmacokinetics of this drug in these patients.
- Determine the tumor response in patients treated with this drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.
- Being tested
- idronoxil
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
idronoxilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2001
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazia Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Graham Kelly, PhD, Study chair, MEI Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022295
- Sponsor's protocol ID
- CDR0000068802
- Other IDs
- NOVOGEN-NV06-0024, CCF-4269, NCI-V01-1663
- Status last verified
- Mar 2007
- First submitted
- 10 Aug 2001
- Last updated
- 26 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients With Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors Are Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT00022295
- Acronym / sponsor ID
- CDR0000068802
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kazia Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
- Determine the steady-state pharmacokinetics of this drug in these patients.
- Determine the tumor response in patients treated with this drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| idronoxil | Drug | – |
Primary outcome
Not reported in the source record.
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 26 Mar 2013.
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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.
Graham Kelly, PhD study chair
MEI Pharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing idronoxil in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Kazia Therapeutics Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Where can I read the original study information?
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 26 Mar 2013.