Breast NeoplasmPhase 2NCT01015521
Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer
A Phase 2 study testing Aminoflavone Prodrug in people with Breast Neoplasm, run by Tigris Pharmaceuticals.
Trial summary
This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative and ER+ breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Aminoflavone Prodrug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2012
- Phase
- Phase 2
- 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
- ER+ or TN Breast Cancer
- Progression on an aromatase inhibitor if ER+
- Prior treatment with taxane if TN
- 18 years or older
- Adequate organ function
- Measurable lesion
Who cannot join
- symptomatic pulmonary disease
- brain metastases
- pregnant females
About this study
Official title: A Two-Arm Open Label Phase II Study of AFP464 (Aminoflavone Prodrug) in Previously-treated ER-positive or Triple-negative Breast Cancer Patients
This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative and ER+ breast cancer.
- Conditions
- Breast Neoplasm
- Being tested
- Aminoflavone Prodrug
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminoflavone ProdrugDrug
Also called AFP464
Aminoflavone Prodrug administered D1, D8 of 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Aminoflavone Prodrug | Experimental | Aminoflavone to treat ER positive breast cancer patients Receives: Drug: Aminoflavone Prodrug |
| Aminoflavone Prodrug with pretreatment | Experimental | Aminoflavone Prodrug to treat Triple Negative Breast Cancer Receives: Drug: Aminoflavone Prodrug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Response
Measured: 6 months
Secondary outcomes (1)
Progression Free Survival
Measured: 6 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startApr 2010
- Primary completionDec 2012 (estimated)
Why it stopped: Study was not initiated as planned
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 Breast NeoplasmStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tigris Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015521
- Sponsor's protocol ID
- TG-AFP-002
- Status last verified
- Nov 2010
- First submitted
- 16 Nov 2009
- Last updated
- 3 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Saito R, Miki Y, Hata S, Ishida T, Suzuki T, Ohuchi N, Sasano H. Aryl hydrocarbon receptor induced intratumoral aromatase in breast cancer. Breast Cancer Res Treat. 2017 Feb;161(3):399-407. doi: 10.1007/s10549-016-4063-x. Epub 2016 Nov 30.
PubMed 27900579
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm Open Label Phase II Study of AFP464 (Aminoflavone Prodrug) in Previously-treated ER-positive or Triple-negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01015521
- Acronym / sponsor ID
- TG-AFP-002
- Conditions
- Breast Neoplasm
- Keywords
- breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated as planned
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tigris PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (estimated)
- First posted
- 18 Nov 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.
This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative and ER+ breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminoflavone Prodrug | Experimental | Drug: Aminoflavone ProdrugAminoflavone to treat ER positive breast cancer patients |
| Aminoflavone Prodrug with pretreatment | Experimental | Drug: Aminoflavone ProdrugAminoflavone Prodrug to treat Triple Negative Breast Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ER+ or TN Breast Cancer
- Progression on an aromatase inhibitor if ER+
- Prior treatment with taxane if TN
- 18 years or older
- Adequate organ function
Key exclusion criteria (3 listed)
- symptomatic pulmonary disease
- brain metastases
- pregnant females
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 |
|---|---|---|
| Aminoflavone ProdrugAlso: AFP464Aminoflavone Prodrug administered D1, D8 of 21-day cycle | Drug | Aminoflavone Prodrug, Aminoflavone Prodrug with pretreatment |
Primary outcome
Clinical Benefit Response
Time frame: 6 months
1 secondary outcome
Progression Free Survival
Time frame: 6 monhts
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2010.
- Derived from this study: PubMed 27900579Saito R, Miki Y, Hata S, Ishida T, Suzuki T, Ohuchi N, Sasano H. Aryl hydrocarbon receptor induced intratumoral aromatase in breast cancer. Breast Cancer Res Treat. 2017 Feb;161(3):399-407. doi: 10.1007/s10549-016-4063-x. Epub 2016 Nov 30.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aminoflavone Prodrug in people with Breast Neoplasm, run by Tigris Pharmaceuticals.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 3 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical Benefit Response (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 NCT01015521, 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 3 Nov 2010.