Breast NeoplasmsPhase 2NCT01953536
Safety and Efficacy Study of Vintafolide and Vintafolide Plus Paclitaxel Compared to Paclitaxel Alone in Participants With Triple Negative Breast Cancer (TNBC) (MK-8109-004)
A Phase 2 study testing Vintafolide 2.5 mg, Paclitaxel 80 mg/m^2 and Etarfolatide in people with Breast Neoplasms, run by Endocyte.
Trial summary
The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Vintafolide 2.5 mg, Paclitaxel 80 mg/m^2 and Etarfolatide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Nov 2016
- 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
- Female with histologically or cytologically confirmed estrogen receptor negative, progesterone receptor negative, human epidermal growth factor receptor 2 (HER-2) negative advanced breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Has developed progressive disease following at least 1 (and not more than 4) prior chemotherapeutic regimens for breast cancer, which was administered for treatment of locally advanced, locally recurrent and/or metastatic disease. [At least 1 regimen must have included a taxane (e.g., paclitaxel, docetaxel) in any combination or order.]
- Has at least a single measurable target lesion on a radiological evaluation that is conducted no more than 4 weeks prior to beginning of study drug. (Measurable lesions should not have received prior radiation therapy.)
- Has not received chemotherapy for 4 weeks prior to the initiation of study drug and must have recovered to ≤Common Terminology Criteria for Adverse Events (CTCAE) grade 1 toxicities related to prior chemotherapies.
- Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug.
- Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 30 days after the last dose of study drug.
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- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has no history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin or has undergone potentially curative therapy with no evidence of that disease for 5 years.
- Has adequate organ function.
Who cannot join
- Has had chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to study drug administration or has not recovered (≤Grade 1 or baseline) from adverse experiences due to agents administered more than 4 weeks earlier.
- Is currently participating or has participated in a study with an investigational compound or device within 28 days of initial dosing on this study.
- Has received more than 4 prior cytotoxic regimens for metastatic disease. Adjuvant treatments would not count towards this criterion.
- Has a primary central nervous system (CNS) tumor.
- Has active CNS metastases and/or carcinomatous meningitis.
- Has had prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.
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- Has known hypersensitivity to paclitaxel, docetaxel, other taxane therapies, drugs formulated with polyoxyethylated castor oil (Cremophor EL®), vinblastine, other vinca derived therapies, or their components or analogs.
- Has pre-existing neuropathy >Grade 2.
- Has a recent (i.e., ≤6 weeks) history of abdominal surgery or peritonitis.
- Has a bowel occlusion or sub-occlusion.
- Has had prior abdominal or pelvic radiation therapy, or radiation therapy to >10% of the bone marrow at any time in the past, or prior radiation therapy within the last 3 years to the breast/sternum, dermal lesions, head, or neck.
- Requires anti-folate therapy.
- Has known psychiatric or substance abuse disorders.
- Is a known regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
- Is expecting to reproduce within the projected duration of the study, and women who are pregnant or breastfeeding.
- Is known to be Human Immunodeficiency Virus (HIV)-positive.
- Has known active Hepatitis B or C.
- Has symptomatic ascites or pleural effusion.
- Has had a prior stem cell or bone marrow transplant.
About this study
Official title: A Phase IIa Open Label, Randomized Clinical Trial to Study the Safety and Efficacy of Vintafolide and the Combination of Vintafolide and Paclitaxel Compared to Paclitaxel in Subjects With Advanced Triple Negative Breast Cancer Using Etarfolatide (EC20) Subject Selection
The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC).
The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.
Read the detailed description
During the screening stage, participants will be required to have a diagnostic computed tomography (CT) scan with etarfolatide (EC20) to identify target lesions and determine eligibility for treatment. After successful screening, during the treatment stage, participants will receive study drug (vintafolide, vintafolide + paclitaxel, or paclitaxel) for approximately four 28-day cycles.
- Conditions
- Breast Neoplasms
- Being tested
- Vintafolide 2.5 mg, Paclitaxel 80 mg/m^2, Etarfolatide, Folic acid, Premedication for Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vintafolide 2.5 mgDrug
During treatment, participants receive IV vintafolide 2.5 mg.
Paclitaxel 80 mg/m^2Drug
During treatment, participants receive IV paclitaxel 80 mg/m^2.
EtarfolatideDrug
During screening and prior to screening CT scan, participants receive an IV injection of 0.1 mg etarfolatide radiolabeled with 20 to 25 milliCuries of technetium-99m.
Folic acidDrug
During screening and prior to etarfolatide injection and screening CT scan, participants receive an IV injection of 0.5 mg folic acid.
Premedication for PaclitaxelDrug
During treatment, participants receive dexamethasone 20 mg orally 12 to 6 hours prior to paclitaxel; OR promethazine 25 mg or 50 mg IV 30 to 60 minutes prior to paclitaxel; OR cimetidine 300 mg IV or ranitidine 50 mg IV 30 to 60 minutes prior to paclitaxel.
| Study group | Role | What they receive |
|---|---|---|
| Vintafolide | Experimental | Participants receive intravenous (IV) vintafolide 2.5 mg on Days 1, 3, 5, 15, 17, and 19 of a 28-day cycle. Receives: Drug: Vintafolide 2.5 mg; Drug: Etarfolatide; Drug: Folic acid |
| Vintafolide + Paclitaxel | Experimental | Participants receive IV vintafolide 2.5 mg on Days 1, 3, 5, 15, 17, and 19 of one 28-day cycle and receive IV paclitaxel on Days 1, 8, 15, and 22 of a 28-day cycle. Receives: Drug: Vintafolide 2.5 mg; Drug: Paclitaxel 80 mg/m^2; Drug: Etarfolatide; Drug: Folic acid; Drug: Premedication for Paclitaxel |
| Paclitaxel | Active comparator | Participants receive IV paclitaxel on Days 1, 8, 15, and 22 of a 28-day cycle. Receives: Drug: Paclitaxel 80 mg/m^2; Drug: Etarfolatide; Drug: Folic acid; Drug: Premedication for Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: Up to 60 months
Secondary outcomes (3)
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
Measured: Up to 60 months
Clinical Benefit Rate (CR + PR + Stable Disease [SD] for >=6 months)
Measured: Up to 60 months
Overall Survival (OS)
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocyte
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953536
- Sponsor's protocol ID
- 8109-004
- Other IDs
- 2012-005170-65
- Status last verified
- Dec 2014
- First submitted
- 25 Sep 2013
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Open Label, Randomized Clinical Trial to Study the Safety and Efficacy of Vintafolide and the Combination of Vintafolide and Paclitaxel Compared to Paclitaxel in Subjects With Advanced Triple Negative Breast Cancer Using Etarfolatide (EC20) Subject Selection
- ClinicalTrials.gov ID
- NCT01953536
- Acronym / sponsor ID
- 8109-004
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EndocyteIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 1 Oct 2013 (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 assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC).
The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.
Detailed description
During the screening stage, participants will be required to have a diagnostic computed tomography (CT) scan with etarfolatide (EC20) to identify target lesions and determine eligibility for treatment. After successful screening, during the treatment stage, participants will receive study drug (vintafolide, vintafolide + paclitaxel, or paclitaxel) for approximately four 28-day cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vintafolide | Experimental | Drug: Vintafolide 2.5 mg, Drug: Etarfolatide, Drug: Folic acidParticipants receive intravenous (IV) vintafolide 2.5 mg on Days 1, 3, 5, 15, 17, and 19 of a 28-day cycle. |
| Vintafolide + Paclitaxel | Experimental | Drug: Vintafolide 2.5 mg, Drug: Paclitaxel 80 mg/m^2, Drug: Etarfolatide, Drug: Folic acid, Drug: Premedication for PaclitaxelParticipants receive IV vintafolide 2.5 mg on Days 1, 3, 5, 15, 17, and 19 of one 28-day cycle and receive IV paclitaxel on Days 1, 8, 15, and 22 of a 28-day cycle. |
| Paclitaxel | Active comparator | Drug: Paclitaxel 80 mg/m^2, Drug: Etarfolatide, Drug: Folic acid, Drug: Premedication for PaclitaxelParticipants receive IV paclitaxel on Days 1, 8, 15, and 22 of a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female with histologically or cytologically confirmed estrogen receptor negative, progesterone receptor negative, human epidermal growth factor receptor 2 (HER-2) negative advanced breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Has developed progressive disease following at least 1 (and not more than 4) prior chemotherapeutic regimens for breast cancer, which was administered for treatment of locally advanced, locally recurrent and/or metastatic disease. [At least 1 regimen must have included a taxane (e.g., paclitaxel, docetaxel) in any combination or order.]
- Has at least a single measurable target lesion on a radiological evaluation that is conducted no more than 4 weeks prior to beginning of study drug. (Measurable lesions should not have received prior radiation therapy.)
- Has not received chemotherapy for 4 weeks prior to the initiation of study drug and must have recovered to ≤Common Terminology Criteria for Adverse Events (CTCAE) grade 1 toxicities related to prior chemotherapies.
- Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug.
Key exclusion criteria (19 listed)
- Has had chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to study drug administration or has not recovered (≤Grade 1 or baseline) from adverse experiences due to agents administered more than 4 weeks earlier.
- Is currently participating or has participated in a study with an investigational compound or device within 28 days of initial dosing on this study.
- Has received more than 4 prior cytotoxic regimens for metastatic disease. Adjuvant treatments would not count towards this criterion.
- Has a primary central nervous system (CNS) tumor.
- Has active CNS metastases and/or carcinomatous meningitis.
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 |
|---|---|---|
| Vintafolide 2.5 mgDuring treatment, participants receive IV vintafolide 2.5 mg. | Drug | Vintafolide, Vintafolide + Paclitaxel |
| Paclitaxel 80 mg/m^2During treatment, participants receive IV paclitaxel 80 mg/m^2. | Drug | Paclitaxel, Vintafolide + Paclitaxel |
| EtarfolatideDuring screening and prior to screening CT scan, participants receive an IV injection of 0.1 mg etarfolatide radiolabeled with 20 to 25 milliCuries of technetium-99m. | Drug | Paclitaxel, Vintafolide, Vintafolide + Paclitaxel |
| Folic acidDuring screening and prior to etarfolatide injection and screening CT scan, participants receive an IV injection of 0.5 mg folic acid. | Drug | Paclitaxel, Vintafolide, Vintafolide + Paclitaxel |
| Premedication for PaclitaxelDuring treatment, participants receive dexamethasone 20 mg orally 12 to 6 hours prior to paclitaxel; OR promethazine 25 mg or 50 mg IV 30 to 60 minutes prior to paclitaxel; OR cimetidine 300 mg IV or ranitidine 50 mg IV 30 to 60 minutes prior to paclitaxel. | Drug | Paclitaxel, Vintafolide + Paclitaxel |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to 60 months
3 secondary outcomes
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
Time frame: Up to 60 months
Clinical Benefit Rate (CR + PR + Stable Disease [SD] for >=6 months)
Time frame: Up to 60 months
Overall Survival (OS)
Time frame: Up to 60 months
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 19 Dec 2014.
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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 Vintafolide 2.5 mg, Paclitaxel 80 mg/m^2 and Etarfolatide in people with Breast Neoplasms, run by Endocyte.
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 9 inclusion and 19 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 19 Dec 2014. 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?
Progression Free Survival (PFS) (time frame: Up to 60 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 19 Dec 2014.