BRCA-Mutated Ovarian CarcinomaEarly Phase 1NCT03943173
Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery
A Early Phase 1 study testing Chemotherapy, Olaparib and Therapeutic Conventional Surgery in people with BRCA-Mutated Ovarian Carcinoma and BRCA1 Gene Mutation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This early phase I trial studies how well olaparib works in treating patients with newly diagnosed BRCA-mutant ovarian, primary peritoneal, or fallopian cancer before surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- BRCA-Mutated Ovarian Carcinoma, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- What is being tested?
- Chemotherapy, Olaparib and Therapeutic Conventional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2019to 27 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer
- Documented BRCA pathway mutations
- No prior treatment for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube carcinoma such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy, surgery, and/or other concurrent agents or therapies
- A disposition to neoadjuvant chemotherapy (NACT) with planned interval tumor reductive surgery after 3 complete cycles of treatment
- Have measurable disease based on RECIST version 1.1 or evaluable disease. Measurable disease is defined at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each "target" lesion must be > 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or > 10 mm when measured by spiral CT. Evaluable disease includes nonmeasurable lesions, ascites, pleural effusion
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- Peripheral neuropathy grade 0 or 1 by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of >= 16 weeks
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as: amenorrheic for 1 year or more following cessation of exogenous hormonal treatments, luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50, radiation-induced oophorectomy with last menses > 1 year ago, chemotherapy-induced menopause with > 1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy). Women of childbearing potential (WoCBP) must utilize acceptable contraception for two weeks before the first dose of olaparib, for the duration of the study, and for at least 6 months after the last dose of olaparib
- Hemoglobin >= 10.0 g/dL (with no blood transfusion in the past 28 days) (measured within 28 days prior to administration of study treatment)
- Absolute neutrophil count (ANC) >= 1.5 x 109/L (> 1500 per mm3) (measured within 28 days prior to administration of study treatment)
- Platelet count >= 100 x 109/L (> 100,000 per mm3) (measured within 28 days prior to administration of study treatment)
- Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN unless liver metastases are present, in which case it must be =< 5 x ULN (measured within 28 days prior to administration of study treatment)
- Serum creatinine clearance (CrCL) >= 51 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of CrCL (measured within 28 days prior to administration of study treatment)
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrollment in the present study
- Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer
- Histology showing mucinous or low grade epithelial carcinoma
- Participation in another clinical study with an investigational product (IP) during the last 4 weeks
- History of another primary malignancy except for: malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, and/or adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ
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- Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, mean QT interval corrected for heart rate with Fridericia's correction (QTcF) prolongation > 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome
- Any unresolved toxicity (> CTCAE grade 2) from previous anti-cancer therapy, excluding alopecia
- History of hypersensitivity to olaparib or its excipients
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or otherwise immunocompromised subjects, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- History of leptomeningeal carcinomatosis
- Subjects who are pregnant and/or breast-feeding
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study results
- Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids. The subject can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
- Subjects with uncontrolled seizures
- Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
- Any previous treatment with PARP inhibitor, including olaparib
- Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks
- Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort ) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
- Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
- Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to treatment)
- Non-English speakers will be excluded from participating in the patient-reported outcomes component of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NOW: Neoadjuvant Olaparib Window Trial in Newly Diagnosed BRCA-Mutant Ovarian Cancer
This early phase I trial studies how well olaparib works in treating patients with newly diagnosed BRCA-mutant ovarian, primary peritoneal, or fallopian cancer before surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of daily olaparib given in the neoadjuvant setting in women with primary advanced high grade non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
SECONDARY OBJECTIVES:
- Estimate efficacy of olaparib given in the neoadjuvant setting using response rate (by Response Evaluation Criteria in Solid Tumors [RECIST] in subjects with measurable disease).
II. Estimate proportion of subjects able to proceed immediately to interval tumor reductive surgery (without chemotherapy).
III. Determine progression-free survival (PFS). IV. Determine complete pathologic response rate at the time of surgery. V. Determine the toxicity of daily olaparib given in the neoadjuvant setting. VI. Evaluate the toxicity of chemotherapy given after neoadjuvant olaparib. VII. Measure longitudinal symptom burden of study subjects treated with neoadjuvant olaparib and chemotherapy after olaparib.
EXPLORATORY OBJECTIVES:
- Explore deoxyribonucleic acid (DNA) copy number and level of ribonucleic acid (RNA) and protein expression in homologous recombination-related pathways before and after treatment with olaparib in women with primary advanced high grade non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
II. Correlate molecular results to clinical endpoints including response and survival.
OUTLINE:
Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After treatment, patients either undergo surgery then receive standard chemotherapy for up to 4 cycles or receive standard chemotherapy within 14 days for up to 4 cycles then undergo surgery in the absence of disease progression or unacceptable toxicity at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 30 days.
- Conditions
- BRCA-Mutated Ovarian Carcinoma, BRCA1 Gene Mutation, BRCA2 Gene Mutation, High Grade Fallopian Tube Serous Adenocarcinoma, High Grade Ovarian Serous Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma
- Being tested
- Chemotherapy, Olaparib, Therapeutic Conventional Surgery
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Given standard chemotherapy
OlaparibDrug
Also called AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281
Given PO
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment (olaparib) | Experimental | Patients receive olaparib PO BID on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After treatment, patients either undergo surgery then receive standard chemotherapy for up to 4 cycles or receive standard chemotherapy within 14 days for up to 4 cycles then undergo surgery in the absence of disease progression or unacceptable toxicity at the discretion of the treating physician. Receives: Drug: Chemotherapy; Drug: Olaparib; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of olaparib
Feasibility defined by number of subjects who are able to receive two cycles of PARP inhibition without unacceptable toxicity or disease progression (new disease or increase of CA125 from baseline > 50%). Will be analyzed using descriptive statistics. Will be estimated using a 90% credible interval
Measured: Up to 1 year
Secondary outcomes (7)
Response rate
For categorical endpoints, standard descriptive statistics, including frequency table and exact 95% confidence intervals will be computed using the Clopper-Pearson method.
Measured: U to 1 year
Complete pathologic response
For categorical endpoints, standard descriptive statistics, including frequency table and exact 95% confidence intervals will be computed using the Clopper-Pearson method.
Measured: For up to 1 year
Incidence of adverse events
For categorical endpoints, standard descriptive statistics, including frequency table and exact 95% confidence intervals will be computed using the Clopper-Pearson method.
Measured: For up to 1 year
Symptom burden and health status
Will be assessed by the MD Anderson Symptom Inventory (MDASI) ."For categorical endpoints, standard descriptive statistics, including frequency table and exact 95% confidence intervals will be computed using the Clopper-Pearson method.
Measured: For up to 1 year
Progression-free survival
Summarized using descriptive statistics, including Kaplan-Meier curve and estimates.
Measured: Up to 1 year
Symptom burden and health status
Will be assessed by EuroQol 5-dimension. For categorical endpoints, standard descriptive statistics, including frequency table and exact 95% confidence intervals will be computed using the Clopper-Pearson method.
Measured: For up to 1 year
Symptom burden and health status
Will be assessed by 5-level (EQ-5D-5L) instruments. For categorical endpoints, standard descriptive statistics, including frequency table and exact 95% confidence intervals will be computed using the Clopper-Pearson method.
Measured: 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 posted9 May 2019
- Study start7 Jun 2019
- Primary completion27 Jun 2027 (estimated)
- Study completion27 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA-Mutated Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shannon N Westin, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943173
- Sponsor's protocol ID
- 2018-0775
- Other IDs
- NCI-2019-00503, 2018-0775
- Status last verified
- Aug 2026
- First submitted
- 21 Feb 2019
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pending discussions with AstraZeneca regarding the level and quantity of data that may be shared. Discussions will also include potential modifications of the contract to allow for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOW: Neoadjuvant Olaparib Window Trial in Newly Diagnosed BRCA-Mutant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03943173
- Acronym / sponsor ID
- 2018-0775
- Conditions
- BRCA-Mutated Ovarian Carcinoma, BRCA1 Gene Mutation, BRCA2 Gene Mutation, High Grade Fallopian Tube Serous Adenocarcinoma, High Grade Ovarian Serous Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 27 Jun 2027 (estimated)
- Study completion
- 27 Jun 2027 (estimated)
- First posted
- 9 May 2019 (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.
This early phase I trial studies how well olaparib works in treating patients with newly diagnosed BRCA-mutant ovarian, primary peritoneal, or fallopian cancer before surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of daily olaparib given in the neoadjuvant setting in women with primary advanced high grade non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
SECONDARY OBJECTIVES:
- Estimate efficacy of olaparib given in the neoadjuvant setting using response rate (by Response Evaluation Criteria in Solid Tumors [RECIST] in subjects with measurable disease).
II. Estimate proportion of subjects able to proceed immediately to interval tumor reductive surgery (without chemotherapy).
III. Determine progression-free survival (PFS). IV. Determine complete pathologic response rate at the time of surgery. V. Determine the toxicity of daily olaparib given in the neoadjuvant setting. VI. Evaluate the toxicity of chemotherapy given after neoadjuvant olaparib. VII. Measure longitudinal symptom burden of study subjects treated with neoadjuvant olaparib and chemotherapy after olaparib.
EXPLORATORY OBJECTIVES:
- Explore deoxyribonucleic acid (DNA) copy number and level of ribonucleic acid (RNA) and protein expression in homologous recombination-related pathways before and after treatment with olaparib in women with primary advanced high grade non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
II. Correlate molecular results to clinical endpoints including response and survival.
OUTLINE:
Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After treatment, patients either undergo surgery then receive standard chemotherapy for up to 4 cycles or receive standard chemotherapy within 14 days for up to 4 cycles then undergo surgery in the absence of disease progression or unacceptable toxicity at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (olaparib) | Experimental | Drug: Chemotherapy, Drug: Olaparib, Procedure: Therapeutic Conventional SurgeryPatients receive olaparib PO BID on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After treatment, patients either undergo surgery then receive standard chemotherapy for up to 4 cycles or receive standard chemotherapy within 14 days for up to 4 cycles then undergo surgery in the absence of disease progression or unacceptable toxicity at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer
- Documented BRCA pathway mutations
- No prior treatment for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube carcinoma such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy, surgery, and/or other concurrent agents or therapies
- A disposition to neoadjuvant chemotherapy (NACT) with planned interval tumor reductive surgery after 3 complete cycles of treatment
Key exclusion criteria (24 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrollment in the present study
- Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer
- Histology showing mucinous or low grade epithelial carcinoma
- Participation in another clinical study with an investigational product (IP) during the last 4 weeks
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 |
|---|---|---|
| ChemotherapyAlso: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, GeneralGiven standard chemotherapy | Drug | Treatment (olaparib) |
| OlaparibAlso: AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281Given PO | Drug | Treatment (olaparib) |
| Therapeutic Conventional SurgeryUndergo surgery | Procedure or surgery | Treatment (olaparib) |
Primary outcome
Feasibility of olaparib
Time frame: Up to 1 year
Feasibility defined by number of subjects who are able to receive two cycles of PARP inhibition without unacceptable toxicity or disease progression (new disease or increase of CA125 from baseline > 50%). Will be analyzed using descriptive statistics. Will be estimated using a 90% credible interval
7 secondary outcomes
Response rate
Time frame: U to 1 year
Complete pathologic response
Time frame: For up to 1 year
Incidence of adverse events
Time frame: For up to 1 year
Symptom burden and health status
Time frame: For up to 1 year
Progression-free survival
Time frame: Up to 1 year
Symptom burden and health status
Time frame: For up to 1 year
Symptom burden and health status
Time frame: For up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No. Pending discussions with AstraZeneca regarding the level and quantity of data that may be shared. Discussions will also include potential modifications of the contract to allow for data sharing.
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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.
Shannon N Westin principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chemotherapy, Olaparib and Therapeutic Conventional Surgery in people with BRCA-Mutated Ovarian Carcinoma and BRCA1 Gene Mutation, run by M.D. Anderson Cancer Center at 1 site 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 24 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of olaparib (time frame: Up to 1 year). 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 12 Aug 2026.