Metastatic Triple Negative Breast CancerPhase 2VERU-111NCT05008510
P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC .
A Phase 2 study testing Sabizabulin, Sacituzumab Govitecan-hziy and Sabizabulin/Sacituzumab govitecan-hziy Combo in people with Metastatic Triple Negative Breast Cancer, run by Veru Inc..
Trial summary
To compare the following: 1. The efficacy of sabizabulin monotherapy to sacituzumab govitecan-hziy monotherapy 2. The efficacy of sacituzumab govitecan-hziy/sabizabulin combination therapy to sacituzumab govitecan-hziy monotherapy These comparisons will be made in the efficacy in the treatment of metastatic triple… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Metastatic Triple Negative Breast Cancer
- What is being tested?
- Sabizabulin, Sacituzumab Govitecan-hziy and Sabizabulin/Sacituzumab govitecan-hziy Combo
- 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
- 30 Dec 2021to 30 Jun 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide informed consent
- Be able to communicate effectively with the study personnel
- Aged ≥18 years
- For Female Subjects
- Menopausal status Be postmenopausal as defined by the National Comprehensive Cancer
- Network as either:
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- Age ≥55 years and one year or more of amenorrhea
- Age <55 years and one year or more of amenorrhea, with an estradiol assay <20 pg/mL
- Age <55 years and surgical menopause with bilateral oophorectomy Be premenopausal or perimenopausal with a negative urine pregnancy test. If subject is of child-bearing potential, the subject must agree to use acceptable methods of contraception:
- If female study participant could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization of male partner (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}
- If female study participant has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
- If female study participant has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
- For Male Subjects
- Subject must agree to use acceptable methods of contraception:
- If the study subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
- If female partner of a study subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
- If female partner of a study subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
- If female partner of a study subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization.
- Measurable disease is required as per RECIST 1.1 confirmed by BICR (NOTE: Bone only metastatic disease is acceptable but requires a measurable component).
- Refractory to or relapsed after at least two prior standard chemotherapy regimens for advanced/metastatic TNBC and have not received Sacituzumab govitecan-hziy.
- At least 2 weeks beyond prior anti-cancer treatment (chemotherapy, radiotherapy, and/or major surgery), and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).
- At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
- Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
- Adverse events at study entry < Grade 1 by NCI CTCAE v5.0 (Patients with ≤ Grade 2 neuropathy and any grade of alopecia are eligible).
- Patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.
- Subject is willing to comply with the requirements of the protocol through the end of the study.
Who cannot join
- Women who are pregnant or lactating
- Women of childbearing potential or fertile men with a female partner of childbearing potential not willing to use effective contraction during the study and 6 months after last dose of study drug for the women of childbearing potential participating in the study and for 3 months after last dose of study drug in fertile men with a female partner of childbearing potential.
- Known hypersensitivity or allergy to sabizabulin or Sacituzumab govitecan-hziy
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 X upper limit of normal (ULN) or total bilirubin >ULN (an elevated total bilirubin up to 1.5 X ULN attributed to a previously confirmed diagnosis of Gilbert's disease is acceptable if all other eligibility criteria are met). In patients with documented metastases to the liver, the limits for inclusion are ALT or AST >5.0 X ULN or total bilirubin >1.5 X ULN.
- Patients with biliary catheter
- Creatinine Clearance ≤60 mL/min by the Cockroft-Gault equation
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- Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years (note: subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or cervical carcinoma in situ that have undergone potentially curative therapy are not excluded)
- Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- Infection requiring antibiotic use within one week or randomization or uncontrolled infection.
- Treatment with any investigational product within < 4 half-lives for each individual investigational product OR within 28 days prior to randomization
- Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment
About this study
Official title: Phase 2 Clinical Efficacy and Safety Study of Sabizabulin (VERU-111) Monotherapy and Sacituzumab Govitecan-hziy/Sabizabulin Combination Therapy for the Treatment of Metastatic Triple Negative Breast Cancer
To compare the following:
- The efficacy of sabizabulin monotherapy to sacituzumab govitecan-hziy monotherapy
- The efficacy of sacituzumab govitecan-hziy/sabizabulin combination therapy to sacituzumab govitecan-hziy monotherapy
These comparisons will be made in the efficacy in the treatment of metastatic triple negative breast cancer (mTNBC) in patients previously treated with at least two systemic chemotherapies for metastatic disease as measured by radiographic progression free survival (rPFS) as the primary endpoint.
Read the detailed description
Stage 1: This is a safety run-in portion of the study for the combination therapy. Three subjects will be enrolled into Stage 1 of the study to receive sacituzumab govitecan-hziy for injection + sabizabulin 32 mg. Dosing with sabizabulin should be within 1 hour prior to initiation of the sacituzumab govitecan-hziy infusion.
Safety will be assessed for 21 days. Samples for assessment of pharmacokinetics of sacutizumab (in the Control Treated Group and TS Combination Group), and sabizabulin (in the Sabizabulin Treated Group and TS Combination Group) will be collected on Day 1 (prior to dosing and within 1 hour after the sacituzumab govitecan-hziy infusion has been completed in Stage 1 and Stage 2, Cycle 1 only), Day 3 (prior to dosing with sabizabulin, Stage 1, Cycle 1 only), and Day 8 (prior to dosing and within 1 hour after the sacituzumab govitecan-hziy infusion has been completed in Stage 1 and Stage 2, Cycle 1 only).
The primary objective of Stage 1 is to demonstrate an acceptable safety profile of the combination therapy regimen that is planned for Stage 2 of the protocol. If an acceptable safety profile and no unacceptable drug related adverse event is observed in Stage 1, then Stage 2 will be initiated as designed. If an unacceptable drug related adverse event is observed in one patient in the combination treatment group in Stage 1, then an additional 3 patients will be enrolled to the combination treatment arm. If 2 out of 3 or 2 out of 6 patients experience an unacceptable drug related adverse event in Stage 1, then the combination treatment regimen will not be dosed in Stage 2 of this protocol.
Stage 2: This study is a multicenter, randomized, open-label, three treatment-arm, efficacy and safety study. Subjects will be randomized to the three treatment arms.
Patients will be randomized in a 1:1:1 fashion to the sacituzumab govitecan-hziy monotherapy, sabizabulin monotherapy, and the sacituzumab govitecan-hziy/sabizabulin combination therapy treatment arms.
Subjects in the Sabizabulin Treated Group and sacituzumab govitecan-hziy/sabizabulin Combination Group will receive sabizabulin 32 mg per day orally until radiographic progression (blinded independent central read) in observed. Subjects in the Control Treated Group and in the sacituzumab govitecan-hziy/sabizabulin Combination Group will receive sacituzumab govitecan-hziy using the dose and dosing regimen defined in the FDA approved prescribing information for the treatment of mTNBC until radiographic progression in observed.
The primary efficacy endpoint of the study will be the median rPFS. Subjects will continue study treatment until disease progression confirmed by blinded independent central reader (BICR) is observed. A follow up visit will occur approximately 30 days after last dose of study drug.
- Conditions
- Metastatic Triple Negative Breast Cancer
- Being tested
- Sabizabulin, Sacituzumab Govitecan-hziy, Sabizabulin/Sacituzumab govitecan-hziy Combo
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SabizabulinDrug
Also called Veru-111
Sabizabulin (Veru-111)
Sacituzumab Govitecan-hziyDrug
Sacituzumab govitecan-hziy
Sabizabulin/Sacituzumab govitecan-hziy ComboDrug
Also called Sacituzumab govitecan-hziy and Veru-111 combo
Sabizabulin/Sacituzumab govitecan-hziy Combo therpy
| Study group | Role | What they receive |
|---|---|---|
| Sabizabulin Monotherapy | Experimental | Subjects in the Sabizabulin Treated Group will receive sabizabulin 32 mg each day by mouth until disease progression confirmed by BICR is observed. Receives: Drug: Sabizabulin |
| Sacituzumab govitecan-hziy/Sabizabulin Combination | Experimental | Subjects in the Sacituzumab govitecan-hziy /Sabizabulin Combination Treated Group will receive sabizabulin 32 mg each day by mouth and Sacituzumab govitecan-hziy at the FDA approved dose and dosage regimen for mTNBC until disease progression confirmed by BICR is observed. Receives: Drug: Sabizabulin/Sacituzumab govitecan-hziy Combo |
| Sacituzumab govitecan-hziy Monotherpy | Active comparator | Subjects in the Control Treated Group will receive Sacituzumab govitecan-hziy intravenous infusion of 10 mg/kg in accordance with the FDA approved use and dosage regimen for mTNBC until disease progression confirmed by BICR is observed. Receives: Drug: Sacituzumab Govitecan-hziy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of sabizabulin monotherapy to Sacituzumab govitecan-hziy monotherapy
The comparison will be made in the efficacy in the treatment of metastatic triple negative breast cancer (mTNBC) in patients previously treated with at least two systemic chemotherapies for metastatic disease as measured by radiographic progression free survival (rPFS) as the primary endpoint.
Measured: 360 days
To compare the efficacy of Sacituzumab govitecan-hziy/sabizabulin combination therapy to Sacituzumab govitecan-hziy monotherapy
The comparison will be made in the efficacy in the treatment of metastatic triple negative breast cancer (mTNBC) in patients previously treated with at least two systemic chemotherapies for metastatic disease as measured by radiographic progression free survival (rPFS) as the primary endpoint.
Measured: 360 days
Secondary outcomes (1)
Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (PR or CR) on study
Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (PR or CR) on study
Measured: 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start30 Dec 2021 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Why it stopped: Decided to halt and will potentially reopen in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple Negative Breast 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter, randomized, open-label, three treatment-arm, efficacy and safety study. Subjects will be randomized to the three treatment arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veru Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barnette, Study chair, Veru Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008510
- Sponsor's protocol ID
- V2011801
- Acronym
- VERU-111
- Status last verified
- Jan 2022
- First submitted
- 10 Aug 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Efficacy and Safety Study of Sabizabulin (VERU-111) Monotherapy and Sacituzumab Govitecan-hziy/Sabizabulin Combination Therapy for the Treatment of Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05008510
- Acronym / sponsor ID
- VERU-111 / V2011801
- Conditions
- Metastatic Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided to halt and will potentially reopen in the future.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Veru Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 17 Aug 2021 (actual)
- 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.
To compare the following:
- The efficacy of sabizabulin monotherapy to sacituzumab govitecan-hziy monotherapy
- The efficacy of sacituzumab govitecan-hziy/sabizabulin combination therapy to sacituzumab govitecan-hziy monotherapy
These comparisons will be made in the efficacy in the treatment of metastatic triple negative breast cancer (mTNBC) in patients previously treated with at least two systemic chemotherapies for metastatic disease as measured by radiographic progression free survival (rPFS) as the primary endpoint.
Detailed description
Stage 1: This is a safety run-in portion of the study for the combination therapy. Three subjects will be enrolled into Stage 1 of the study to receive sacituzumab govitecan-hziy for injection + sabizabulin 32 mg. Dosing with sabizabulin should be within 1 hour prior to initiation of the sacituzumab govitecan-hziy infusion.
Safety will be assessed for 21 days. Samples for assessment of pharmacokinetics of sacutizumab (in the Control Treated Group and TS Combination Group), and sabizabulin (in the Sabizabulin Treated Group and TS Combination Group) will be collected on Day 1 (prior to dosing and within 1 hour after the sacituzumab govitecan-hziy infusion has been completed in Stage 1 and Stage 2, Cycle 1 only), Day 3 (prior to dosing with sabizabulin, Stage 1, Cycle 1 only), and Day 8 (prior to dosing and within 1 hour after the sacituzumab govitecan-hziy infusion has been completed in Stage 1 and Stage 2, Cycle 1 only).
The primary objective of Stage 1 is to demonstrate an acceptable safety profile of the combination therapy regimen that is planned for Stage 2 of the protocol. If an acceptable safety profile and no unacceptable drug related adverse event is observed in Stage 1, then Stage 2 will be initiated as designed. If an unacceptable drug related adverse event is observed in one patient in the combination treatment group in Stage 1, then an additional 3 patients will be enrolled to the combination treatment arm. If 2 out of 3 or 2 out of 6 patients experience an unacceptable drug related adverse event in Stage 1, then the combination treatment regimen will not be dosed in Stage 2 of this protocol.
Stage 2: This study is a multicenter, randomized, open-label, three treatment-arm, efficacy and safety study. Subjects will be randomized to the three treatment arms.
Patients will be randomized in a 1:1:1 fashion to the sacituzumab govitecan-hziy monotherapy, sabizabulin monotherapy, and the sacituzumab govitecan-hziy/sabizabulin combination therapy treatment arms.
Subjects in the Sabizabulin Treated Group and sacituzumab govitecan-hziy/sabizabulin Combination Group will receive sabizabulin 32 mg per day orally until radiographic progression (blinded independent central read) in observed. Subjects in the Control Treated Group and in the sacituzumab govitecan-hziy/sabizabulin Combination Group will receive sacituzumab govitecan-hziy using the dose and dosing regimen defined in the FDA approved prescribing information for the treatment of mTNBC until radiographic progression in observed.
The primary efficacy endpoint of the study will be the median rPFS. Subjects will continue study treatment until disease progression confirmed by blinded independent central reader (BICR) is observed. A follow up visit will occur approximately 30 days after last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a multicenter, randomized, open-label, three treatment-arm, efficacy and safety study. Subjects will be randomized to the three treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Sabizabulin Monotherapy | Experimental | Drug: SabizabulinSubjects in the Sabizabulin Treated Group will receive sabizabulin 32 mg each day by mouth until disease progression confirmed by BICR is observed. |
| Sacituzumab govitecan-hziy/Sabizabulin Combination | Experimental | Drug: Sabizabulin/Sacituzumab govitecan-hziy ComboSubjects in the Sacituzumab govitecan-hziy /Sabizabulin Combination Treated Group will receive sabizabulin 32 mg each day by mouth and Sacituzumab govitecan-hziy at the FDA approved dose and dosage regimen for mTNBC until disease progression confirmed by BICR is observed. |
| Sacituzumab govitecan-hziy Monotherpy | Active comparator | Drug: Sacituzumab Govitecan-hziySubjects in the Control Treated Group will receive Sacituzumab govitecan-hziy intravenous infusion of 10 mg/kg in accordance with the FDA approved use and dosage regimen for mTNBC until disease progression confirmed by BICR is observed. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Provide informed consent
- Be able to communicate effectively with the study personnel
- Aged ≥18 years
- For Female Subjects
- Menopausal status Be postmenopausal as defined by the National Comprehensive Cancer
Key exclusion criteria (11 listed)
- Women who are pregnant or lactating
- Women of childbearing potential or fertile men with a female partner of childbearing potential not willing to use effective contraction during the study and 6 months after last dose of study drug for the women of childbearing potential participating in the study and for 3 months after last dose of study drug in fertile men with a female partner of childbearing potential.
- Known hypersensitivity or allergy to sabizabulin or Sacituzumab govitecan-hziy
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 X upper limit of normal (ULN) or total bilirubin >ULN (an elevated total bilirubin up to 1.5 X ULN attributed to a previously confirmed diagnosis of Gilbert's disease is acceptable if all other eligibility criteria are met). In patients with documented metastases to the liver, the limits for inclusion are ALT or AST >5.0 X ULN or total bilirubin >1.5 X ULN.
- Patients with biliary catheter
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 |
|---|---|---|
| SabizabulinAlso: Veru-111Sabizabulin (Veru-111) | Drug | Sabizabulin Monotherapy |
| Sacituzumab Govitecan-hziySacituzumab govitecan-hziy | Drug | Sacituzumab govitecan-hziy Monotherpy |
| Sabizabulin/Sacituzumab govitecan-hziy ComboAlso: Sacituzumab govitecan-hziy and Veru-111 comboSabizabulin/Sacituzumab govitecan-hziy Combo therpy | Drug | Sacituzumab govitecan-hziy/Sabizabulin Combination |
Primary outcome
To compare the efficacy of sabizabulin monotherapy to Sacituzumab govitecan-hziy monotherapy
Time frame: 360 days
The comparison will be made in the efficacy in the treatment of metastatic triple negative breast cancer (mTNBC) in patients previously treated with at least two systemic chemotherapies for metastatic disease as measured by radiographic progression free survival (rPFS) as the primary endpoint.
To compare the efficacy of Sacituzumab govitecan-hziy/sabizabulin combination therapy to Sacituzumab govitecan-hziy monotherapy
Time frame: 360 days
The comparison will be made in the efficacy in the treatment of metastatic triple negative breast cancer (mTNBC) in patients previously treated with at least two systemic chemotherapies for metastatic disease as measured by radiographic progression free survival (rPFS) as the primary endpoint.
1 secondary outcome
Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (PR or CR) on study
Time frame: 360 days
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 8 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Barnette study chair
Veru Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sabizabulin, Sacituzumab Govitecan-hziy and Sabizabulin/Sacituzumab govitecan-hziy Combo in people with Metastatic Triple Negative Breast Cancer, run by Veru Inc..
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 28 inclusion and 11 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 8 Feb 2022. 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?
To compare the efficacy of sabizabulin monotherapy to Sacituzumab govitecan-hziy monotherapy (time frame: 360 days). The study lists 2 primary outcomes in all. 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 8 Feb 2022.