Small-cell Lung CancerPhase 1NCT03532880
A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer
A Phase 1 study testing Olaparib Pill 50 mg, Olaparib Pill 100 mg and Olaparib Pill 150 mg in people with Small-cell Lung Cancer and Small Cell Lung Carcinoma, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial summary
The purpose of this study is to test the safety of a new medication, Olaparib, combined with radiation therapy for participants with small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer, Small Cell Lung Carcinoma
- What is being tested?
- Olaparib Pill 50 mg, Olaparib Pill 100 mg and Olaparib Pill 150 mg
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Jul 2018to 4 Feb 2025
- 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
- Histological documented diagnosis of SCLC confirmed by a MSKCC pathologist.
- Documented extensive disease, defined as any tumor beyond the above limited disease definition, including ipsilateral lung metastases and malignant pleural effusion
- Completion of induction chemotherapy with a minimum of 4 and no more than 6 cycles of a platinum agent and etoposide within 8 weeks of trial initiation.
- No disease progression (i.e.SD or better response per treating physician descretion) at the completion of chemotherapy.
- Age 18 years or older.
- Intrathoracic disease should be encompassable in acceptable radiation fields per investigator clinical judgement.
Show all 23Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnosfsky Performance Score (KPS) >/= 70
- Patients must have adequately recovered from any adverse events associated with prior immune-chemotherapy
- Adequate organ and marrow function, including:
- Haemoglobin >/= 8.0 g/dL with no blood transfusion in the past 28 days.
- Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L.
- Platelet count >/= 100 x 10^9/L.
- Total bilirubin </= 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) </= 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be </= 5x ULN.
- Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of >/= 51 mL/min
- Patients must have a life expectancy >/= 16 weeks.
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
- Postmenopausal is defined as any one or more of the following: i. Age >/= 60 years. ii. Age < 60 and amenorrheic for 1 year or more in the absence of chemotherapy and/or hormonal treatment.
- Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 60.
- Radiation-induced oophorectomy with last menses >1 year ago v. Chemotherapy-induced menopause with > 1 year interval since last menses. vi. Surgical sterilisation (bilateral oophorectomy or hysterectomy).
- Men and women of childbearing potential must be willing to us two highly effective forms of contraception while on treatment and for at least 3 months after last dose of study drug.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- Written informed consent
Who cannot join
- Untreated brain metastases.
- Pneumonitis
- Previous radiotherapy to thorax (prior breast RT is permitted).
- Patient is not a candidate for or declines consolidative thoracic radiotherapy.
- Patients receiving any systemic chemotherapy or thoracic radiotherapy within 3 weeks prior to study treatment.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Show all 27Show fewer
- Previous enrolment in the present study.
- Exposure to an investigational product within 30 days or 5 half lives (whichever is longer) prior to start of the current study drug.
- Any previous treatment with PARP inhibitor, including olaparib, for the treatment of small cell lung cancer
- Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or a documented family history of long QT syndrome.
- Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
- Concomitant use of known strong CYP3A inducers (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- For patients who have received prior immunotherapy, treatment must be held from 10 days prior to protocol treatment until 10 days after completing protocol treatment.
- Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
- Patients with myelodysplastic syndrome/acute leukaemia or with features suggestive thereof.
- Major surgery within 2 weeks of study treatment initiation and patients must have recovered from any effects of any major surgery.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active/uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Breast feeding women.
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product
- Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
- Previous allogenic 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, for timing refer to inclusion criteria number 8)
- Other malignancy within the last 5 years except: early stage cutaneous melanoma, adequately treated non-melanomatous skin cancer, curatively treated in situ cervical cancer, ductal carcinoma in situ (DCIS), FIGO Grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >/= 5 years. Patients with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Absence of brain metastases is not required. Patients must not have symptomatic brain metastatic disease. The patient may be symptomatically controlled on 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Baptist Alliance Miami Cancer Institute
Miami, Florida, 33143
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Phase I Study of Olaparib and Low Dose Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
The purpose of this study is to test the safety of a new medication, Olaparib, combined with radiation therapy for participants with small cell lung cancer.
- Conditions
- Small-cell Lung Cancer, Small Cell Lung Carcinoma
- Being tested
- Olaparib Pill 50 mg, Olaparib Pill 100 mg, Olaparib Pill 150 mg, Olaparib Pill 200 mg, Olaparib Pill 250 mg
- Keywords
- Olaparib, Radiation therapy, 18-195, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaparib Pill 50 mgDrug
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib Pill 100 mgDrug
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib Pill 150 mgDrug
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib Pill 200 mgDrug
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib Pill 250 mgDrug
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib Pill 300 mgDrug
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
RadiotherapyRadiation
The total prescribed dose will be 30 Gy in ten daily fractions of 3 Gy each delivered during business days over 2 calendar weeks.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Small Cell Lung Cancer | Experimental | Not described Receives: Drug: Olaparib Pill 50 mg; Drug: Olaparib Pill 100 mg; Drug: Olaparib Pill 150 mg; Drug: Olaparib Pill 200 mg; Drug: Olaparib Pill 250 mg; Drug: Olaparib Pill 300 mg; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of olaparib in combination with low dose thoracic radiotherapy
Measured: 1 year
Safety of olaparib in combination with low dose thoracic radiotherapy by evaluating participant toxicities and adverse events
For safety, all adverse events as determined by the investigator using CTCAE
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start12 Jul 2018
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abraham Wu, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532880
- Sponsor's protocol ID
- 18-195
- Status last verified
- Jan 2025
- First submitted
- 9 May 2018
- Last updated
- 7 Feb 2025
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Olaparib and Low Dose Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03532880
- Acronym / sponsor ID
- 18-195
- Conditions
- Small-cell Lung Cancer, Small Cell Lung Carcinoma
- Keywords
- Olaparib, Radiation therapy, 18-195, Memorial Sloan Kettering Cancer Center
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 22 May 2018 (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.
The purpose of this study is to test the safety of a new medication, Olaparib, combined with radiation therapy for participants with small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Small Cell Lung Cancer | Experimental | Drug: Olaparib Pill 50 mg, Drug: Olaparib Pill 100 mg, Drug: Olaparib Pill 150 mg, Drug: Olaparib Pill 200 mg, Drug: Olaparib Pill 250 mg, Drug: Olaparib Pill 300 mg, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histological documented diagnosis of SCLC confirmed by a MSKCC pathologist.
- Documented extensive disease, defined as any tumor beyond the above limited disease definition, including ipsilateral lung metastases and malignant pleural effusion
- Completion of induction chemotherapy with a minimum of 4 and no more than 6 cycles of a platinum agent and etoposide within 8 weeks of trial initiation.
- No disease progression (i.e.SD or better response per treating physician descretion) at the completion of chemotherapy.
- Age 18 years or older.
Key exclusion criteria (27 listed)
- Untreated brain metastases.
- Pneumonitis
- Previous radiotherapy to thorax (prior breast RT is permitted).
- Patient is not a candidate for or declines consolidative thoracic radiotherapy.
- Patients receiving any systemic chemotherapy or thoracic radiotherapy within 3 weeks prior to study treatment.
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 |
|---|---|---|
| Olaparib Pill 50 mgOlaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23) | Drug | Participants with Small Cell Lung Cancer |
| Olaparib Pill 100 mgOlaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23) | Drug | Participants with Small Cell Lung Cancer |
| Olaparib Pill 150 mgOlaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23) | Drug | Participants with Small Cell Lung Cancer |
| Olaparib Pill 200 mgOlaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23) | Drug | Participants with Small Cell Lung Cancer |
| Olaparib Pill 250 mgOlaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23) | Drug | Participants with Small Cell Lung Cancer |
| Olaparib Pill 300 mgOlaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23) | Drug | Participants with Small Cell Lung Cancer |
| RadiotherapyThe total prescribed dose will be 30 Gy in ten daily fractions of 3 Gy each delivered during business days over 2 calendar weeks. | Radiation | Participants with Small Cell Lung Cancer |
Primary outcome
Maximum tolerated dose (MTD) of olaparib in combination with low dose thoracic radiotherapy
Time frame: 1 year
Safety of olaparib in combination with low dose thoracic radiotherapy by evaluating participant toxicities and adverse events
Time frame: 1 year
For safety, all adverse events as determined by the investigator using CTCAE
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 7 Feb 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Small-cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Abraham Wu, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 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 Olaparib Pill 50 mg, Olaparib Pill 100 mg and Olaparib Pill 150 mg in people with Small-cell Lung Cancer and Small Cell Lung Carcinoma, run by Memorial Sloan Kettering Cancer Center at 9 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 23 inclusion and 27 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 olaparib in combination with low dose thoracic radiotherapy (time frame: 1 year). 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 7 Feb 2025.