Breast NeoplasmPhase 2NCT01233947
Study of AFP464 +/- Faslodex in ER + Breast Cancer
A Phase 2 study testing AFP464 and AFP464 + Faslodex in people with Breast Neoplasm, run by Tigris Pharmaceuticals at 1 site in United States.
Trial summary
AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- AFP464 and AFP464 + Faslodex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum CA27.29>=50 U/mL; adequate bone marrow, liver and renal function; DLco grade 0 or 1.
Who cannot join
- HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
About this study
Official title: A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy
AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.
Read the detailed description
This is a randomized, open-label study. Patients will be randomized in a 1:1 ratio to single arm AFP464, or AFP464+Faslodex. Patients will be treated until disease progression is noted.
- Conditions
- Breast Neoplasm
- Being tested
- AFP464, AFP464 + Faslodex
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFP464Drug
Also called (aminoflavone)
AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle
AFP464 + FaslodexDrug
Also called (aminoflavone) + (Fulvestrant)
AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label
| Study group | Role | What they receive |
|---|---|---|
| AFP464 | Experimental | 74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle. Receives: Drug: AFP464 |
| AFP464 + Faslodex | Experimental | AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label. Receives: Drug: AFP464 + Faslodex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Response
Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
Measured: 6 months
Secondary outcomes (2)
Progression Free Survival
Determination of progression free survival
Measured: 6 months
Number of participants with adverse events
Determination of the number of patients who experience adverse events
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 posted3 Nov 2010 (estimated)
- Study startMay 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tigris Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joanne L. Blume, M.D., Principal investigator, Texas Oncology-Baylor Charles A. Sammons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233947
- Sponsor's protocol ID
- TG-AFP-003
- Status last verified
- Jan 2012
- First submitted
- 1 Nov 2010
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy
- ClinicalTrials.gov ID
- NCT01233947
- Acronym / sponsor ID
- TG-AFP-003
- Conditions
- Breast Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tigris PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 3 Nov 2010 (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.
AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.
Detailed description
This is a randomized, open-label study. Patients will be randomized in a 1:1 ratio to single arm AFP464, or AFP464+Faslodex. Patients will be treated until disease progression is noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFP464 | Experimental | Drug: AFP46474 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle. |
| AFP464 + Faslodex | Experimental | Drug: AFP464 + FaslodexAFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum CA27.29>=50 U/mL; adequate bone marrow, liver and renal function; DLco grade 0 or 1.
Key exclusion criteria (1 listed)
- HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,
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 |
|---|---|---|
| AFP464Also: (aminoflavone)AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle | Drug | AFP464 |
| AFP464 + FaslodexAlso: (aminoflavone) + (Fulvestrant)AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label | Drug | AFP464 + Faslodex |
Primary outcome
Clinical Benefit Response
Time frame: 6 months
Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
2 secondary outcomes
Progression Free Survival
Time frame: 6 months
Number of participants with adverse events
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
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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.
Joanne L. Blume, M.D. principal investigator
Texas Oncology-Baylor Charles A. Sammons Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AFP464 and AFP464 + Faslodex in people with Breast Neoplasm, run by Tigris Pharmaceuticals 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?
The sponsor lists 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Jan 2012. 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 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 stopped early. Results are not available in the source record.
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?
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 9 Jan 2012.