Breast Cancer Nos Metastatic RecurrentPhase 2NCT01703754
Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.
A Phase 2 study testing Ad-RTS-hIL-12 and Veledimex and Palifosfamide in people with Breast Cancer Nos Metastatic Recurrent, run by Alaunos Therapeutics at 8 sites in United States.
Trial summary
Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions. Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Nos Metastatic Recurrent
- What is being tested?
- Ad-RTS-hIL-12 and Veledimex and Palifosfamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Apr 2013to 7 Aug 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males or females ≥ 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the breast, either locally recurrent or metastatic disease with injectable lesions, for which no proven curative therapy exists.
- Failed or progressed on at least 1 prior systemic chemotherapy regimen ± biologic/experimental therapy (if first-line therapy, failure or progression during the first 30 days).
- Resolution of all treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
- A minimum of 2 lesion(s) assessed by imaging using mRECIST v1.1.
- Eastern Cooperative Oncology Group performance status 0, 1, 2
Show all 16Show fewer
- Male and female subjects must agree to use a highly reliable method of birth control.
- Adequate bone marrow reserve as indicated by:
- Absolute neutrophil count > 1500/μL (without use of growth factors within 7 days)
- Absolute lymphocyte count > 700/μL (without use of growth factors within 7 days)
- Platelet count > 100,000/mm3 (without transfusion in prior 7 days)
- Hemoglobin > 9.0 g/dL (without transfusion in prior 7 days)
- Estimated glomerular filtration rate using the Modification of Diet in Renal Disease equation: eGFR ≥ 60 mL/min/1.73 m2
- Adequate liver function as evidenced by the following:
- Bilirubin ≤ 1.5 times the upper limits of normal (ULN)
- Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5×ULN, in the case of liver metastases ≤ 5×ULN
Who cannot join
- Subjects with human epidermal growth factor receptor 2 (HER2)/neu-positive (immunohistochemistry [IHC]) 3+ or fluorescence in situ hybridization-amplified) breast tumors who are eligible for, but who have not received HER2-targeted therapy (eg, trastuzumab)
- Concomitant anticancer therapies
- Prior therapies discontinuation periods:
- Radiation within 3 weeks of enrollment
- Chemotherapy within 4 weeks of enrollment
- Nitrosoureas within 6 weeks of enrollment
Show all 26Show fewer
- Biologic therapy and/or immunomodulatory therapy, checkpoint inhibitors within 6 weeks of enrollment
- No washout period is required for endocrine therapy
- Radiation therapy encompassing >25% of bone marrow
- History of bone marrow or stem cell transplantation
- Any congenital or acquired condition leading to inability to generate an immune response
- Immunosuppressive therapy:
- Systemic immunosuppressive drugs including corticosteroids (prednisone equivalent >10 mg/day)
- Immune suppression/requiring immunosuppressive drugs, including organ allografts
- Active autoimmune disease requiring the equivalent of >10 mg/day of prednisone
- Major surgery within 4 weeks of study treatment
- History of prior malignancy, unless the prior malignancy was diagnosed and definitively treated ≥5 years previously with no subsequent evidence of recurrence
- Subjects with brain or subdural metastases, unless local therapy has completed and corticosteroids have been discontinued for this indication for ≥4 weeks before starting study treatment.
- Any medications that induce, inhibit, or are substrates of cytochrome P450 (CYP450) 3A4 within 7 days prior to the first dose of study drug
- Subjects with meningeal carcinomatosis
- Known significant hypersensitivity to study drugs or excipients
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
- International Normalized Ratio (INR) and activated partial thromboplastin time [PTT] <1.5 x ULN, if not therapeutically anticoagulated.
- New York Heart Association (NYHA) Class II or greater congestive heart failure OR active ventricular arrhythmia requiring medication
- Any other unstable or clinically significant concurrent medical condition
- Localized infection at site of injectable lesion(s) requiring antiinfective therapy within 2 weeks of the first dose of study drug.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Billings Clinic
Billings, Montana, 59101
Mary Crowley Medical Research Center
Dallas, Texas, 75201
Henry Ford Health System
Detroit, Michigan, 48202
The Jones Clinic, PC
Germantown, Tennessee, 38138
Greenville Hospital System
Greenville, South Carolina, 29605
Baptist Cancer Institute
Jacksonville, Florida, 32207
Signal Point Clinical Research Center
Middletown, Ohio, 45042
Evergreen Hematology & Oncology
Spokane, Washington, 99218
About this study
Official title: A Phase II Randomized, Open Label Study of Ad-RTS-hIL-12 Monotherapy or Combination With Palifosfamide in Subjects With Recurrent/Metastatic Breast Cancer and Accessible Lesions
Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions.
Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with chemotherapy (palifosfamide) is safe and efficacious.
Read the detailed description
Multicenter, open-label, randomized study evaluating the safety and efficacy of INXN-1001 (veledimex) and INXN-2001 (Ad-RTS-hIL-12) alone and in combination with palifosfamide.
Part 1 is the safety run-in where a safety assessment will be made after 1 cycle of therapy.
Part 2, eligible subjects will be randomly assigned to active treatment Arms A or C.
Once the monotherapy (Arm A) is determined to be safe and tolerable, Part 1 combination therapy (Arm C) will begin.
Subjects should receive six cycles of study treatment, in the absence of meeting withdrawal criteria.
- Conditions
- Breast Cancer Nos Metastatic Recurrent
- Being tested
- Ad-RTS-hIL-12 and Veledimex, Palifosfamide
- Keywords
- Genetically Modified Organism, Metastatic Breast Cancer, Recurrent Breast Cancer, Breast Cancer, Palifosfamide, INXN1001, INXN2001, Adenoviral vector
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad-RTS-hIL-12 and VeledimexGenetic
Also called Adenoviral Vector, Oral activator ligand
Oral activator ligand with adenoviral vector injection of cancer lesions
PalifosfamideDrug
Also called Pali
Small molecule chemotherapy, IV administration
| Study group | Role | What they receive |
|---|---|---|
| Ad-RTS-hIL-12 and veledimex | Experimental | Experimental study drug monotherapy arm (A) Receives: Genetic: Ad-RTS-hIL-12 and Veledimex |
| Ad-RTS-hIL-12 and Palifosfamide | Experimental | Study drug combination therapy arm (C) Receives: Genetic: Ad-RTS-hIL-12 and Veledimex; Drug: Palifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
This measure will capture the incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and AEs leading to discontinuation. As per the protocol, safety and tolerability were assessed by monitoring adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.
Measured: 16 months
16-Week Progression-Free Survival (PFS) Rate
This is the primary efficacy endpoint, defined as the proportion of subjects who had not progressed or died prior to 16 weeks from the date of their first dose. Progression was determined by modified Response Evaluation Criteria in Solid Tumors
Measured: 16 weeks
Secondary outcomes (11)
Best Overall Response (BOR) by mRECIST v1.1
Best Overall Response (BOR) was determined for each evaluable subject up to their final tumor assessment. Per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1, responses were defined as: Complete Response (CR), disappearance of all non-nodal target lesions and reduction in short axis of pathological lymph nodes to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions from baseline; Progressive Disease (PD), at least a 20% increase in the sum of diameters from the smallest sum recorded; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Measured: 24 weeks
Estimate PFS by Modified RECIST v1.1
Progression-free survival (PFS) is the time in days from the first dose of study treatment to the first assessment on which the response is reported as disease progression or death due to any cause (whichever is first) + 1 day. Subjects withdrawing from the study will be censored at their last non-progressive disease response assessment. If a subject does not have a disease response assessment, the subject will be censored on the date of the first treatment as described above.
Kaplan-Meier plots will not be presented; PFS will be listed only.
Measured: 16 months
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001
The area under the plasma concentration versus time curve from time 0 to 24 hours (AUC0-24) for INXN-1001
Measured: Cycle 1 Day 1 and Cycle 1 Day 7
Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay
To assess for a cellular immune response, the number of MUC-1 specific interferon-gamma (IFN-γ) secreting T-cells was measured from peripheral blood mononuclear cells (PBMCs) using an ELISPOT assay. Results are reported as spot-forming cells (SFC) per million PBMCs
Measured: Screening and the Post-Treatment Safety Assessment visit (28 days after the last dose of study drug), with the final assessment occurring up to 7 months after the start of treatment.
Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels
Serum levels of IFN-γ were measured by immunoassay to assess the pharmacodynamic effect of the treatment
Measured: Screening, 24 hours after the first injection (Day 2), and at the Post-Treatment Safety Assessment visit, with the final assessment occurring up to 7 months after the start of treatment.
Change From Baseline in Serum Interleukin-12 (IL-12) Levels
Serum levels of IL-12 were measured by immunoassay to assess the pharmacodynamic effect of the treatment
Measured: Screening, 24 hours after the first injection (Day 2), and at the Post-Treatment Safety Assessment visit, with the final assessment occurring up to 7 months after the start of treatment.
Change From Baseline in CD3+ CD4+ T-Cell Count
Absolute counts of CD3+ CD4+ helper T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations.
Measured: Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7
Change From Baseline in CD3+ CD8+ T-Cell Count
Absolute counts of CD3+ CD8+ cytotoxic T-cells in peripheral blood were measured by flow cytometry to evaluate changes in immune cell populations
Measured: Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7
Maximum Plasma Concentration (Cmax) of INXN-1001
The maximum observed plasma concentration (Cmax) of INXN-1001 following oral administration.
Measured: Cycle 1 Day 1 and Cycle 1 Day 7. On Day 1, samples were collected pre-dose and at 0.5, 1, 2, 4, and 6 hours post-dose. On Day 7, samples were collected pre-dose and at 1-2 and 4-6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of INXN-1001
The time to reach the maximum observed plasma concentration (Tmax) of INXN-1001 following oral administration
Measured: Cycle 1 Day 1 and Cycle 1 Day 7
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) was a pre-specified secondary endpoint defined as the proportion of subjects with a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), as assessed by modified RECIST (mRECIST) v1.1.
Measured: From the first dose of study treatment for up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study start4 Apr 2013
- Primary completion7 Aug 2014
- Study completion7 Aug 2014
Why it stopped: After SRC review and Sponsor's halting palifosfamide development, data was collected for Part 1, Arm A. Doses of 80, 100, and 140 mg were used. The SRC reduced 140 mg to 100 mg, then to 80 mg. The study ended with one subject enrolled at 80 mg daily.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer Nos Metastatic RecurrentStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaymes Holland, Study director, Alaunos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703754
- Sponsor's protocol ID
- ATI001-201
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2012
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Open Label Study of Ad-RTS-hIL-12 Monotherapy or Combination With Palifosfamide in Subjects With Recurrent/Metastatic Breast Cancer and Accessible Lesions
- ClinicalTrials.gov ID
- NCT01703754
- Acronym / sponsor ID
- ATI001-201
- Conditions
- Breast Cancer Nos Metastatic Recurrent
- Keywords
- Genetically Modified Organism, Metastatic Breast Cancer, Recurrent Breast Cancer, Breast Cancer, Palifosfamide, INXN1001, INXN2001, Adenoviral vector
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After SRC review and Sponsor's halting palifosfamide development, data was collected for Part 1, Arm A. Doses of 80, 100, and 140 mg were used. The SRC reduced 140 mg to 100 mg, then to 80 mg. The study ended with one subject enrolled at 80 mg daily.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2013 (actual)
- Primary completion
- 7 Aug 2014 (actual)
- Study completion
- 7 Aug 2014 (actual)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Posted 28 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions.
Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with chemotherapy (palifosfamide) is safe and efficacious.
Detailed description
Multicenter, open-label, randomized study evaluating the safety and efficacy of INXN-1001 (veledimex) and INXN-2001 (Ad-RTS-hIL-12) alone and in combination with palifosfamide.
Part 1 is the safety run-in where a safety assessment will be made after 1 cycle of therapy.
Part 2, eligible subjects will be randomly assigned to active treatment Arms A or C.
Once the monotherapy (Arm A) is determined to be safe and tolerable, Part 1 combination therapy (Arm C) will begin.
Subjects should receive six cycles of study treatment, in the absence of meeting withdrawal criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ad-RTS-hIL-12 and veledimex | Experimental | Genetic: Ad-RTS-hIL-12 and VeledimexExperimental study drug monotherapy arm (A) |
| Ad-RTS-hIL-12 and Palifosfamide | Experimental | Genetic: Ad-RTS-hIL-12 and Veledimex, Drug: PalifosfamideStudy drug combination therapy arm (C) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males or females ≥ 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the breast, either locally recurrent or metastatic disease with injectable lesions, for which no proven curative therapy exists.
- Failed or progressed on at least 1 prior systemic chemotherapy regimen ± biologic/experimental therapy (if first-line therapy, failure or progression during the first 30 days).
- Resolution of all treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
- A minimum of 2 lesion(s) assessed by imaging using mRECIST v1.1.
Key exclusion criteria (26 listed)
- Subjects with human epidermal growth factor receptor 2 (HER2)/neu-positive (immunohistochemistry [IHC]) 3+ or fluorescence in situ hybridization-amplified) breast tumors who are eligible for, but who have not received HER2-targeted therapy (eg, trastuzumab)
- Concomitant anticancer therapies
- Prior therapies discontinuation periods:
- Radiation therapy encompassing >25% of bone marrow
- History of bone marrow or stem cell transplantation
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 |
|---|---|---|
| Ad-RTS-hIL-12 and VeledimexAlso: Adenoviral Vector, Oral activator ligandOral activator ligand with adenoviral vector injection of cancer lesions | Genetic | Ad-RTS-hIL-12 and Palifosfamide, Ad-RTS-hIL-12 and veledimex |
| PalifosfamideAlso: PaliSmall molecule chemotherapy, IV administration | Drug | Ad-RTS-hIL-12 and Palifosfamide |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: 16 months
This measure will capture the incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and AEs leading to discontinuation. As per the protocol, safety and tolerability were assessed by monitoring adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.
16-Week Progression-Free Survival (PFS) Rate
Time frame: 16 weeks
This is the primary efficacy endpoint, defined as the proportion of subjects who had not progressed or died prior to 16 weeks from the date of their first dose. Progression was determined by modified Response Evaluation Criteria in Solid Tumors
11 secondary outcomes
Best Overall Response (BOR) by mRECIST v1.1
Time frame: 24 weeks
Estimate PFS by Modified RECIST v1.1
Time frame: 16 months
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of INXN-1001
Time frame: Cycle 1 Day 1 and Cycle 1 Day 7
Change From Baseline in MUC-1 Specific T-Cell Response by ELISPOT Assay
Time frame: Screening and the Post-Treatment Safety Assessment visit (28 days after the last dose of study drug), with the final assessment occurring up to 7 months after the start of treatment.
Change From Baseline in Serum Interferon-gamma (IFN-γ) Levels
Time frame: Screening, 24 hours after the first injection (Day 2), and at the Post-Treatment Safety Assessment visit, with the final assessment occurring up to 7 months after the start of treatment.
Change From Baseline in Serum Interleukin-12 (IL-12) Levels
Time frame: Screening, 24 hours after the first injection (Day 2), and at the Post-Treatment Safety Assessment visit, with the final assessment occurring up to 7 months after the start of treatment.
Change From Baseline in CD3+ CD4+ T-Cell Count
Time frame: Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7
Change From Baseline in CD3+ CD8+ T-Cell Count
Time frame: Screening, Cycle 1 the Post-Treatment Safety Assessment visit Day 28 ± 3, and Follow-Up Tumor Assessment visits Day 63 ± 7
Maximum Plasma Concentration (Cmax) of INXN-1001
Time frame: Cycle 1 Day 1 and Cycle 1 Day 7. On Day 1, samples were collected pre-dose and at 0.5, 1, 2, 4, and 6 hours post-dose. On Day 7, samples were collected pre-dose and at 1-2 and 4-6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of INXN-1001
Time frame: Cycle 1 Day 1 and Cycle 1 Day 7
Clinical Benefit Rate (CBR)
Time frame: From the first dose of study treatment for up to 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jaymes Holland study director
Alaunos Therapeutics
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ad-RTS-hIL-12 and Veledimex and Palifosfamide in people with Breast Cancer Nos Metastatic Recurrent, run by Alaunos Therapeutics at 8 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 26 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: 16 months). 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 28 Aug 2025.