BridgeMD
New treatment option for Triple Negative Breast Cancer
Official title Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT04947189
What this study is testing
What is Seviteronel-D (Seivteronel in combination with dexamethasone)?
Seviteronel-D (Seivteronel in combination with dexamethasone) is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for triple negative breast cancer.
Also referred to as INO-464.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed written and voluntary informed consent.
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Age 18 years or older male or female.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- At least 4 weeks washout period from previous line of treatment, 2 weeks from radiotherapy
You likely can't join if
- Inability to comply with study and follow-up procedures.
- History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to...
- Active infection requiring antibiotics.
- Other invasive malignancy within 2 years except for malignancies determined to have low recurrence potential in discussion with study PI.
- Known active tuberculosis.
- Female patients who are pregnant or breast-feeding.
See the full eligibility criteria
- Signed written and voluntary informed consent.
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Age 18 years or older male or female.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- At least 4 weeks washout period from previous line of treatment, 2 weeks from radiotherapy
- Adequate haematologic and organ function within 14 days before the first study treatment on cycle1, day 1
- Life expectancy of at least 3 months
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \<1% per year during the treatment period and for at least...
- Part 1: Histological or cytological-based diagnosis of breast cancer. Any of the three major subtypes of breast cancer is permitted for the phase 1b study, i.e., hormone receptor positive breast cancer i.e. oestrogen...
- Part 2: Histological or cytological-based diagnosis of triple-negative breast cancer. The tumor must be HER2-negative by ASCO/GAO Guidelines and \ 0%) by IHC or gene classifier (molecular testing).
- Measurability of lesion: have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1
- Patients must have advanced or recurrent breast cancer pre-inclusion number 8, for whom docetaxel is considered an appropriate treatment option.
- Inability to comply with study and follow-up procedures.
- History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
- Active infection requiring antibiotics.
- Other invasive malignancy within 2 years except for malignancies determined to have low recurrence potential in discussion with study PI.
- Known active tuberculosis.
- Female patients who are pregnant or breast-feeding.
- Male or female patients of reproductive potential who are not willing to use effective birth control from screening to 90 days post treatment.
- Women of childbearing potential (who are not postmenopausal within 12 months of non-therapy induced amenorrhea, nor surgically sterile) must have a negative serum pregnancy test result within 3 days prior to initiation...
- Uncontrolled intercurrent illness, including psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events, or compromise the ability...
- History or current evidence of HIV infection.
- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (e.g., positive for hepatitis B surface antigen [HBsAg] or hepatitis C virus [HCV]...
- Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen antibody test) are eligible.
- Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the course of the study
- Placement of a vascular access device is not considered major surgery.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the...
- Patients with symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Patients with treated CNS metastases are eligible for this study if they are not receiving corticosteroids and/or...
- Unresolved, clinically significant toxicity NCI CTCAE v5.0 grade 2 or higher, from prior therapy, except for alopecia, endocrinopathy on stable hormonal replacement, and others as approved by study PI.
- Patients who have received palliative radiation treatment to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the...
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Known hypersensitivity or contraindication to any component of the study treatment.
- Administration of any investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.