Advanced CancerPhase 1NCT00664170
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
A Phase 1 study testing ANX-514 and docetaxel in people with Advanced Cancer, run by Mast Therapeutics, Inc. at 13 sites in 3 countries.
Trial summary
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- ANX-514 and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Apr 2008to Apr 2009
- 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
- Over 18 years old.
- Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment.
- ECOG performance status of 0-2 and Karnofsky Score of 100-70.
Who cannot join
- Patients who have more effective therapy available than single agent docetaxel for the malignancy.
- Pregnancy or lactation.
- Intolerance to any antineoplastic agents belonging to the taxoid family.
- Hypersensitivity to drugs formulated with polysorbate 80.
- Active infection.
- Prior anticancer therapy within 30 days prior to the first day of study treatment.
- Participation in another experimental drug study within 30 days prior to the first day of study treatment.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Argentina8 sites
Hospital Universitario Austral
Buenos Aires, Buenos Aires
Marcelo T de Alvear
Buenos Aires, 1122
Hospital Regional de Concepcion
Concepcion, Tucumán Province, 4146
Centro Oncologico de Integracion Regional
Mendoza, 5500
Centro Oncologico de Rosario
Rosario, Santa Fe Province, CP 2000
Hospital Privado Santa Clara de Asis
Salta, 4400
Centro Medico San Roque
San Miguel de Tucumán, 4000
Isis Centro Especializado
Santa Fe, S3000FFU
United States3 sites
UCSD Moores Cancer Center
La Jolla, California, 92093
Signal Point Hematology/Oncology Inc.
Middletown, Ohio, 45042
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661
Estonia2 sites
Tallinn Cancer Clinic
Tallinn, 10167
Tartu University Hospital, Clinic of Hematology and Oncology
Tartu, 51003
About this study
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.
- Conditions
- Advanced Cancer
- Being tested
- ANX-514, docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANX-514Drug
Also called Docetaxel for Injectable Emulsion
75 mg/m^2
docetaxelDrug
Also called Taxotere
75 mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ANX-514 Receives: Drug: ANX-514 |
| 2 | Active comparator | Taxotere Receives: Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic equivalence of ANX-514 and Taxotere
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mast Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeff Stewart, MBA, Study director, Mast Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664170
- Sponsor's protocol ID
- ANX 514-01
- Status last verified
- May 2009
- First submitted
- 18 Apr 2008
- Last updated
- 28 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00664170
- Acronym / sponsor ID
- ANX 514-01
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Apr 2008 (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 compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ANX-514ANX-514 |
| 2 | Active comparator | Drug: docetaxelTaxotere |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old.
- Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment.
- ECOG performance status of 0-2 and Karnofsky Score of 100-70.
Key exclusion criteria (7 listed)
- Patients who have more effective therapy available than single agent docetaxel for the malignancy.
- Pregnancy or lactation.
- Intolerance to any antineoplastic agents belonging to the taxoid family.
- Hypersensitivity to drugs formulated with polysorbate 80.
- Active infection.
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 |
|---|---|---|
| ANX-514Also: Docetaxel for Injectable Emulsion75 mg/m^2 | Drug | 1 |
| docetaxelAlso: Taxotere75 mg/m^2 | Drug | 2 |
Primary outcome
Pharmacokinetic equivalence of ANX-514 and Taxotere
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 28 May 2009.
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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.
Jeff Stewart, MBA study director
Mast Therapeutics, Inc.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ANX-514 and docetaxel in people with Advanced Cancer, run by Mast Therapeutics, Inc. at 13 sites in 3 countries.
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 3 inclusion and 7 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 28 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Argentina, United States, Estonia. 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?
Pharmacokinetic equivalence of ANX-514 and Taxotere. It is what the study was designed to measure, not a finding.
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 28 May 2009.