Metastatic Breast CancerPhase 1NCT02390427
Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer
A Phase 1 study testing Taselisib, Trastuzumab emtansine and Pertuzumab in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Nancy Lin, MD at 3 sites in United States.
Trial summary
This research study is a way of gaining new knowledge about the combination of Taselisib with other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps cancer cells grow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Recurrent Breast Cancer
- What is being tested?
- Taselisib, Trastuzumab emtansine and Pertuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Apr 2015to Jul 2024
- Phase
- Phase 1
- 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
- Metastatic, locally advanced , or locally recurrent breast cancer
- Histologically confirmed HER2+ invasive breast cancer
- Measurable or non-measurable disease per RECIST v1.1
- Prior therapy - Prior trastuzumab, lapatinib, pertuzumab, and trastuzumab emtansine (T-DM1) are allowed. Patients who have received prior therapy with Taselisib (GDC-0032) or BYL-719 are excluded. There is no limit on the number of prior lines of therapy.
- ECOG performance status 0 or 1
- Normal organ and marrow function as defined below:
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- Absolute neutrophil count ≥ 1,500/mm3
- Platelets ≥100,000/mm3
- Total bilirubin < 1.5 X institutional upper limit of normal. For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
- AST (SGOT) and ALT (SGPT) < 2.5 X institutional upper limit of normal
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- Fasting glucose ≤ 120 mg/dL and HbA1c < 7%
- Left ventricular ejection fraction ≥ 50%
- Women of childbearing potential (including those who have had a tubal ligation) must have a documented negative pregnancy test within 14 days prior to planned initiation of Taselisib.
- Ability to understand and the willingness to sign a written informed consent document.
- For Part 2: patients must have tissue that is amenable to biopsy and must be willing to undergo research biopsy. Patients who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol.
Who cannot join
- Anti-cancer therapy within 2 weeks prior to entering the study or those who have not recovered from acute adverse events due to agents administered more than 2 weeks earlier. Palliative radiation to bony metastases ≥2 weeks prior to study entry is allowed.
- Prior treatment with a PI3 kinase, AKT or mTOR inhibitor in which the patient experienced a Grade ≥3 drug related adverse event or otherwise would be at increased risk for additional PI3K related toxicity
- Currently receiving any other investigational agents. Treatment with an investigational agent within 2 weeks prior to planned initiation of study therapy is allowed provided that any drug related toxicity has completely resolved
- Major surgical procedure within 4 weeks prior to planned initiation of study therapy
- Significant traumatic injury within 3 weeks prior to planned initiation of study therapy
- Known untreated brain metastases are excluded. History of treated CNS metastases is okay, provided the following criteria are met:
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- Disease outside the CNS is present.
- No evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study
- No history of intracranial hemorrhage or spinal cord hemorrhage
- Not requiring anti-convulsants for symptomatic control
- Minimum of 3 weeks between completion of CNS radiotherapy and Cycle 1 Day 1 and recovery from significant (Grade ≥ 3) acute toxicity with no ongoing requirement for corticosteroid
- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to the Taselisib drug formulation or other agents used in this study.
- Receiving any medications or substances that are inhibitors of CYP3A4.
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Active small or large intestine inflammation such as Crohn's disease or ulcerative colitis
- Type 1 or 2 diabetes requiring anti hyperglycemic medication (e.g. metformin, glipizide, insulin)
- Leptomeningeal disease as the only manifestation of the current malignancy
- Congenital long QT syndrome or QTc > 500 msec
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Uncontrolled ascites requiring weekly large volume paracentesis for 2 consecutive weeks prior to initiation of study treatment
- Active infection requiring intravenous (IV) antibiotics
- Patients requiring any daily supplemental oxygen
- Uncontrolled hypomagnesemia, hypokalemia or hypocalcemia, defined as values below the lower limit of normal (LLN) for the institution despite adequate electrolyte supplementation or management
- Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Grade ≥2 peripheral neuropathy
- Any other diseases, active or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, pulmonary dysfunction, metabolic dysfunction, psychiatric illness/social situations, physical examination finding, or clinical laboratory finding that would limit compliance with study requirements.
- Women of childbearing potential (< 1 year amenorrheic) or sexually active males who are not employing adequate contraception (or practicing complete abstinence).
- Female patients of childbearing potential must commit to using a reliable and appropriate method of contraception until at least 7 months after the end of last dose of study treatment.
- Male patients with a partner of childbearing potential must agree to use a barrier method of contraception (condom) in addition to having their partner use another contraceptive method during the trial and for 7 months after the last dose of study treatment.
- Pregnant women and women who are lactating.
- Known human immunodeficiency virus (HIV) infection
- Inability or unwillingness to swallow pills
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
This research study is a way of gaining new knowledge about the combination of Taselisib with other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps cancer cells grow. This drug has been used in laboratory experiments and information from these studies suggests that this drug may help to prevent or slow the growth of cancer cells. The main purpose of this study is to find the appropriate dose of Taselisib to be used with other drugs in further clinical studies. This is an open-label, 3+3 dose-escalation phase Ib study to identify the Maximum Tolerated Dose(s) (MTD) and to identify the recommended phase 2 dose (RP2D) of Taselisib. This study will be conducted in 4 separate arms. (A-D).
Read the detailed description
This study is divided in two parts, a combination dose finding escalation part (Part 1) and a dose combination expansion part (Part 2). Participants will enter only one Part (either 1 or 2) and receive study drugs from only one combindation of study drugs, know as arms, as assigned by the main study physician. The study includes four different arms as listed below:
- Arm A: Taselisib with Trastuzumab emtansine (also called T-DM1)
- Arm B: Taselisib with Trastuzumab emtansine and Pertuzumab
- Arm C: Taselisib with Pertuzumab and Trastuzumab
- Arm D: Taselisib with Pertuzumab, Trastuzumab, and Paclitaxel
Part 1: Since we are looking for the highest dose of Taselisib that can be administered safely without severe or unmanageable side effects in participants that have breast cancer, not everyone who participates in Part 1 of this research study will receive the same dose of the Taselisib. The dose participants get will depend on the number of participants who have been enrolled in the study before and how well they have tolerated their doses.
Each combination dose will only be given to a group of 3 - 6 participants. The results from each group will be reviewed and depending on the results, a different combination dose or schedule may be investigated in the next group of participants or the same combination dose taken by a participant may be repeated with the next group of participants to investigate these results further (a different schedule means that instead of taking doses once every day, participants may take them only on some days in the week).
Part 2: The doses in this part will be based on the best combination doses from Part 1. This part will look at the potential side effects and see how your cancer responds to the drug.
- Conditions
- Metastatic Breast Cancer, Recurrent Breast Cancer
- Being tested
- Taselisib, Trastuzumab emtansine, Pertuzumab, Trastuzumab, Paclitaxel
- Keywords
- Metastatic Breast Cancer, Advanced Breast Cancer, Recurrent 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.
TaselisibDrug
Also called GCD-0032
Trastuzumab emtansineDrug
Also called T-DM1, Kadcyla
PertuzumabDrug
Also called Perjeta
TrastuzumabDrug
Also called Herceptin
PaclitaxelDrug
Also called Taxol, Onxal
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arm A
- Taselisib with Trastuzumab emtansine (also called T-DM1)
* Taselisib administered orally, daily in each treatment cycle (3 weeks).
* Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks). Receives: Drug: Taselisib; Drug: Trastuzumab emtansine |
| Arm B | Experimental | Arm B
-Taselisib with T-DM1 and Pertuzumab
* Taselisib is administered oral, daily or every other day per treatment cycle (3 weeks).
* Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks).
* Pertuzumab- administered once via IV per treatment cycle (3 weeks). Receives: Drug: Taselisib; Drug: Trastuzumab emtansine; Drug: Pertuzumab |
| Arm C | Experimental | Arm C:
* Taselisib with Pertuzumab and Trastuzumab
* Cohort C will not open without additional authorization from Genentech
* Taselisib is administered oral, daily in each treatment cycle (3 weeks).
* Trastuzumab administered once via IV per treatment cycle (3 weeks).
* Pertuzumab- administered once via IV per treatment cycle (3 weeks). Receives: Drug: Taselisib; Drug: Pertuzumab; Drug: Trastuzumab |
| Arm D | Experimental | Arm D
* Taselisib with Pertuzumab, Trastuzumab, and Paclitaxel
* Cohort will not be opened without additional authorization from Genentech
* Taselisib- administered oral, daily in each treatment cycle (3 weeks).
* Pertuzumab- administered once via IV per treatment cycle (3 weeks).
* Trastuzumab administered once via IV per treatment cycle (3 weeks).
* Paclitaxel- administered via IV, weekly for 3 weeks within each cycle. Receives: Drug: Taselisib; Drug: Pertuzumab; Drug: Trastuzumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Measured: 28 Days
Secondary outcomes (7)
Clinical Benefit Rate (CBR) for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Defined as complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.1
Measured: > or = 6 Months
Progression Free Survival (PFS) for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Defined as the time from the date of the first dose of study treatment until the date of first documentation of progressive disease (PD) or death from any cause (whichever occurs first)
Measured: 2 Years
Overall Survival for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Defined as the time from the date of the first dose of study treatment until the date of death from any cause
Measured: 2 Years
Occurrence of AEs and SAEs during treatment with Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Defined with CTCAE version 4.0
Measured: 2 Years
Occurrence of dose delays or holds
Defined as a delay or hold of one of the study agents for more than 7 days
Measured: More than 7 Days
Occurrence of dose reductions
Measured: 2 Years
Dose Limiting Toxicity of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Defined as a toxicity within the DLT Assessment Window.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start20 Apr 2015
- Primary completionDec 2022
- Study completionJul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nancy Lin, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Nancy Lin, MD, Dana-Farber Cancer Institute
- Investigators
- Nancy Lin, MD, Principal investigator, Dana Farber Cancer Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390427
- Sponsor's protocol ID
- 15-024
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2015
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer
- ClinicalTrials.gov ID
- NCT02390427
- Acronym / sponsor ID
- 15-024
- Conditions
- Metastatic Breast Cancer, Recurrent Breast Cancer
- Keywords
- Metastatic Breast Cancer, Advanced Breast Cancer, Recurrent Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Nancy Lin, MDUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Jul 2024 (actual)
- First posted
- 17 Mar 2015 (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 research study is a way of gaining new knowledge about the combination of Taselisib with other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps cancer cells grow. This drug has been used in laboratory experiments and information from these studies suggests that this drug may help to prevent or slow the growth of cancer cells. The main purpose of this study is to find the appropriate dose of Taselisib to be used with other drugs in further clinical studies. This is an open-label, 3+3 dose-escalation phase Ib study to identify the Maximum Tolerated Dose(s) (MTD) and to identify the recommended phase 2 dose (RP2D) of Taselisib. This study will be conducted in 4 separate arms. (A-D).
Detailed description
This study is divided in two parts, a combination dose finding escalation part (Part 1) and a dose combination expansion part (Part 2). Participants will enter only one Part (either 1 or 2) and receive study drugs from only one combindation of study drugs, know as arms, as assigned by the main study physician. The study includes four different arms as listed below:
- Arm A: Taselisib with Trastuzumab emtansine (also called T-DM1)
- Arm B: Taselisib with Trastuzumab emtansine and Pertuzumab
- Arm C: Taselisib with Pertuzumab and Trastuzumab
- Arm D: Taselisib with Pertuzumab, Trastuzumab, and Paclitaxel
Part 1: Since we are looking for the highest dose of Taselisib that can be administered safely without severe or unmanageable side effects in participants that have breast cancer, not everyone who participates in Part 1 of this research study will receive the same dose of the Taselisib. The dose participants get will depend on the number of participants who have been enrolled in the study before and how well they have tolerated their doses.
Each combination dose will only be given to a group of 3 - 6 participants. The results from each group will be reviewed and depending on the results, a different combination dose or schedule may be investigated in the next group of participants or the same combination dose taken by a participant may be repeated with the next group of participants to investigate these results further (a different schedule means that instead of taking doses once every day, participants may take them only on some days in the week).
Part 2: The doses in this part will be based on the best combination doses from Part 1. This part will look at the potential side effects and see how your cancer responds to the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Taselisib, Drug: Trastuzumab emtansineArm A - Taselisib with Trastuzumab emtansine (also called T-DM1) * Taselisib administered orally, daily in each treatment cycle (3 weeks). * Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks). |
| Arm B | Experimental | Drug: Taselisib, Drug: Trastuzumab emtansine, Drug: PertuzumabArm B -Taselisib with T-DM1 and Pertuzumab * Taselisib is administered oral, daily or every other day per treatment cycle (3 weeks). * Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks). * Pertuzumab- administered once via IV per treatment cycle (3 weeks). |
| Arm C | Experimental | Drug: Taselisib, Drug: Pertuzumab, Drug: TrastuzumabArm C: * Taselisib with Pertuzumab and Trastuzumab * Cohort C will not open without additional authorization from Genentech * Taselisib is administered oral, daily in each treatment cycle (3 weeks). * Trastuzumab administered once via IV per treatment cycle (3 weeks). * Pertuzumab- administered once via IV per treatment cycle (3 weeks). |
| Arm D | Experimental | Drug: Taselisib, Drug: Pertuzumab, Drug: Trastuzumab, Drug: PaclitaxelArm D * Taselisib with Pertuzumab, Trastuzumab, and Paclitaxel * Cohort will not be opened without additional authorization from Genentech * Taselisib- administered oral, daily in each treatment cycle (3 weeks). * Pertuzumab- administered once via IV per treatment cycle (3 weeks). * Trastuzumab administered once via IV per treatment cycle (3 weeks). * Paclitaxel- administered via IV, weekly for 3 weeks within each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Metastatic, locally advanced , or locally recurrent breast cancer
- Histologically confirmed HER2+ invasive breast cancer
- Measurable or non-measurable disease per RECIST v1.1
- Prior therapy - Prior trastuzumab, lapatinib, pertuzumab, and trastuzumab emtansine (T-DM1) are allowed. Patients who have received prior therapy with Taselisib (GDC-0032) or BYL-719 are excluded. There is no limit on the number of prior lines of therapy.
- ECOG performance status 0 or 1
Key exclusion criteria (33 listed)
- Anti-cancer therapy within 2 weeks prior to entering the study or those who have not recovered from acute adverse events due to agents administered more than 2 weeks earlier. Palliative radiation to bony metastases ≥2 weeks prior to study entry is allowed.
- Prior treatment with a PI3 kinase, AKT or mTOR inhibitor in which the patient experienced a Grade ≥3 drug related adverse event or otherwise would be at increased risk for additional PI3K related toxicity
- Currently receiving any other investigational agents. Treatment with an investigational agent within 2 weeks prior to planned initiation of study therapy is allowed provided that any drug related toxicity has completely resolved
- Major surgical procedure within 4 weeks prior to planned initiation of study therapy
- Significant traumatic injury within 3 weeks prior to planned initiation of study therapy
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 |
|---|---|---|
| TaselisibAlso: GCD-0032 | Drug | Arm A, Arm B, Arm C, Arm D |
| Trastuzumab emtansineAlso: T-DM1, Kadcyla | Drug | Arm A, Arm B |
| PertuzumabAlso: Perjeta | Drug | Arm B, Arm C, Arm D |
| TrastuzumabAlso: Herceptin | Drug | Arm C, Arm D |
| PaclitaxelAlso: Taxol, Onxal | Drug | Arm D |
Primary outcome
Maximum Tolerated Dose (MTD) of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Time frame: 28 Days
7 secondary outcomes
Clinical Benefit Rate (CBR) for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Time frame: > or = 6 Months
Progression Free Survival (PFS) for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Time frame: 2 Years
Overall Survival for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Time frame: 2 Years
Occurrence of AEs and SAEs during treatment with Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Time frame: 2 Years
Occurrence of dose delays or holds
Time frame: More than 7 Days
Occurrence of dose reductions
Time frame: 2 Years
Dose Limiting Toxicity of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
Nancy Lin, MD principal investigator
Dana Farber Cancer Insitute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Taselisib, Trastuzumab emtansine and Pertuzumab in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Nancy Lin, MD at 3 sites 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 16 inclusion and 33 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: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel. (time frame: 28 Days). 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 24 Sep 2026.