Advanced CancerPhase 1NCT01655225
A Study of LY3023414 in Participants With Advanced Cancer
A Phase 1 study testing LY3023414, Midazolam and Fulvestrant in people with Advanced Cancer and Metastatic Cancer, run by Eli Lilly and Company at 8 sites in 3 countries.
Trial summary
The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer, Non-Hodgkin's Lymphoma
- What is being tested?
- LY3023414, Midazolam and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 31 Jul 2012to 2 Feb 2022
- 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
- Parts A, A2 \& B1: Participants must have pathological evidence of a diagnosis of advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy
- Part B2: Participants must have advanced, recurrent, or metastatic breast cancer that is refractory to aromatase inhibitors (AI) with either disease recurrence or disease progression; must be hormone receptor positive (HR+) and human epidermal growth factor receptor 2 (HER2)-negative; must be of postmenopausal status or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist
- Part B3 only: Participants must have malignant pleural or peritoneal mesothelioma
- Part B4 only: Participants must have malignant pleural or peritoneal mesothelioma and appropriate candidate for treatment with cisplatin/pemetrexed; no prior systemic chemotherapy
- Part B5 only: Participants must have histologically confirmed diagnosis of B-cell iNHL, with histological subtype; prior treatment with ≥2 prior chemotherapy- or immunotherapy-based regimens for iNHL
- Part B6 only: Participants must have squamous NSCLC; documented evidence of an activating molecular aberration of the PI3K/mTOR pathway
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- Parts B2, B3 \& B6 only: Must have adequate tumor tissue sample from archival biopsy available, or willingness to undergo a fresh tumor biopsy
- Parts B3, B4, B5 \& B6: No previous treatment with any PI3K and/or mTOR inhibitor
- Part B7: Must have a diagnosis of HR+ and HER2- breast cancer; have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease; no previous treatment or currently receiving 1 of the following treatments for locoregionally recurrent or metastatic breast cancer (chemotherapy, endocrine therapy, CDK4/6 inhibitor, and PI3K and/or mTOR inhibitor)
- Measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1), modified RECIST or Revised Response Criteria for Malignant Lymphoma
- Have adequate organ function, including: Absolute neutrophil count (ANC) at least 1.5 x 109/Liter (L), platelets at least 100 x 109/L, and hemoglobin at least 8 grams/deciliter (g/dL); bilirubin no more than 1.5 times upper limits of normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no more than 2.0 times upper limits of normal; Serum creatinine no more than 1.5 times upper limits of normal or calculated creatinine clearance >45 milliliters/minute (mL/min)
- Have a performance status of at least 1 on the Eastern Cooperative Oncology Group (ECOG) scale and life expectancy >6 months
- Have discontinued all previous cancer therapies (except nonsteroidal aromatase inhibitors for participants in Part B2), and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half lives prior to study enrollment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days
- Are able to swallow capsules
Who cannot join
- Have serious preexisting medical conditions
- Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required).
- Have known acute or chronic leukemia or current hematologic malignancies (except iNHL for patients in Part B5) that, in the judgment of the investigator and sponsor, may affect the interpretation of results
- Have an active fungal, bacterial, and/or known viral infection
- Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results (Part B only)
- Part B1 only: No concomitant medications that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) or midazolam
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- Intolerance to any previous treatment with any phosphatidylinositol-3-kinase (PI3K) and/or mammalian target of rapamycin (mTOR) inhibitor.
- Participants with active alcohol abuse, as determined by the investigator
- Have a history of New York Heart Association (NYHA) Class ≥3, unstable angina, or myocardial infarction (MI) in 6 months prior to study drug administration
- Have QT corrected interval of >450 milliseconds (msec) on screening electrocardiogram (ECG)
- Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.
- Part B only: Hypersensitivity to study drugs given in combination with LY3023414
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States6 sites
UCLA Medical Center
Los Angeles, California, 90095
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, 73104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Italy1 site
Azienda Ospedaliero - Universitaria S. Luigi Gonzaga
Orbassano, Torino, 10043
About this study
Official title: A Phase 1 First-in-Human Dose Study of LY3023414 in Patients With Advanced Cancer
The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have.
In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.
- Conditions
- Advanced Cancer, Metastatic Cancer, Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, Malignant Mesothelioma, Non-small Cell Lung Cancer
- Being tested
- LY3023414, Midazolam, Fulvestrant, Pemetrexed, Cisplatin
- Keywords
- Advanced Breast Cancer, Advanced Lung Cancer, Mesothelioma, Lymphoma
- Medical subject headings
- Neoplasm Metastasis, Lymphoma, Non-Hodgkin, Breast Neoplasms, Mesothelioma, Malignant, Carcinoma, Non-Small-Cell Lung, Mesothelioma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3023414Drug
Administered orally. Dose of 20 to 600 mg, as determined in Part A.
MidazolamDrug
0.2 mg administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15.
FulvestrantDrug
500 mg administered IM on Day 1 and Day 15 in cycle 1 and Day 1 every 28 days for additional cycles.
PemetrexedDrug
Also called Alimta
500 mg/m2 administered IV once on Day 1 every 21 days
CisplatinDrug
75 mg/m2 administered IV once on Day 1 every 21 days
AbemaciclibDrug
Also called LY2835219
Administered orally
LetrozoleDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY3023414 Once Daily | Experimental | LY3023414 administered orally once daily (QD) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation. Receives: Drug: LY3023414 |
| Part A2: LY3023414 Twice Daily | Experimental | LY3023414 administered orally twice daily (BID) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation. Receives: Drug: LY3023414 |
| Part B1 : LY3023414 + Midazolam | Experimental | LY3023414 administered orally BID for two 21 day cycles to participants with advanced/metastatic cancer; participants receiving benefit may continue until disease progression or discontinuation. Dose based on Part A. 0.2 milligrams (mg) midazolam administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15. Receives: Drug: LY3023414; Drug: Midazolam |
| Part B2: LY3023414 + Fulvestrant | Experimental | LY3023414 administered orally BID for two 28 day cycles to participants with advanced/metastatic breast cancer; participants receiving benefit may continue until disease progression or discontinuation. 500 mg fulvestrant administered IM once every 28 days. Receives: Drug: LY3023414; Drug: Fulvestrant |
| Part B3: LY3023414 | Experimental | LY3023414 administered orally BID for two 21 day cycles to participants with malignant mesothelioma; participants receiving benefit may continue until disease progression or discontinuation. Receives: Drug: LY3023414 |
| Part B4: LY3023414 + pemetrexed/cisplatin | Experimental | LY3023414 administered orally BID for two 21 day cycles to participants with malignant mesothelioma; participants receiving benefit may continue until disease progression or discontinuation. 500 mg/m2 pemetrexed and 75 mg/m2 administered IV once every 21 days. Receives: Drug: LY3023414; Drug: Pemetrexed; Drug: Cisplatin |
| Part B5: LY3023414 | Experimental | LY3023414 administered orally BID for two 21 day cycles to participants with indolent non-Hodgkin's lymphoma; participants receiving benefit may continue until disease progression or discontinuation. Receives: Drug: LY3023414 |
| Part B6: LY3023414 | Experimental | LY3023414 administered orally BID for two 21 day cycles to participants with squamous NSCLC; participants receiving benefit may continue until disease progression or discontinuation. Receives: Drug: LY3023414 |
| Part B7: LY3023414 + Abemaciclib + Letrozole | Experimental | LY3023414 administered orally BID with abemaciclib administered orally BID and letrozole administered orally once a day for two 28 day cycles to participants with breast cancer; participants receiving benefit may continue until disease progression or discontinuation. Receives: Drug: LY3023414; Drug: Abemaciclib; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 dose
Measured: Baseline to disease progression or participant discontinuation (estimated 9 weeks)
Secondary outcomes (4)
Pharmacokinetics: Maximum concentration (Cmax)
Measured: Predose up to 12 hours postdose
Pharmacokinetics: Time of maximal concentration
Measured: Predose up to 12 hours postdose
Number of participants with tumor response
Measured: Baseline to disease progression or participant discontinuation (estimated 9 weeks)
Potential of LY3023414 to inhibit CYP3A4-mediated metabolism
Measured: Baseline through Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study start31 Jul 2012
- Primary completion4 Apr 2019
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655225
- Sponsor's protocol ID
- 13517
- Other IDs
- I6A-MC-CBBA
- Status last verified
- Apr 2022
- First submitted
- 19 Jul 2012
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Zauderer MG, Alley EW, Bendell J, Capelletto E, Bauer TM, Callies S, Szpurka AM, Kang S, Willard MD, Wacheck V, Varghese AM. Phase 1 cohort expansion study of LY3023414, a dual PI3K/mTOR inhibitor, in patients with advanced mesothelioma. Invest New Drugs. 2021 Aug;39(4):1081-1088. doi: 10.1007/s10637-021-01086-6. Epub 2021 Mar 4.
PubMed 33660194
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human Dose Study of LY3023414 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01655225
- Acronym / sponsor ID
- 13517
- Conditions
- Advanced Cancer, Metastatic Cancer, Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, Malignant Mesothelioma, Non-small Cell Lung Cancer
- Keywords
- Advanced Breast Cancer, Advanced Lung Cancer, Mesothelioma, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2012 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 1 Aug 2012 (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.
The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have.
In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A: LY3023414 Once Daily | Experimental | Drug: LY3023414LY3023414 administered orally once daily (QD) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation. |
| Part A2: LY3023414 Twice Daily | Experimental | Drug: LY3023414LY3023414 administered orally twice daily (BID) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation. |
| Part B1 : LY3023414 + Midazolam | Experimental | Drug: LY3023414, Drug: MidazolamLY3023414 administered orally BID for two 21 day cycles to participants with advanced/metastatic cancer; participants receiving benefit may continue until disease progression or discontinuation. Dose based on Part A. 0.2 milligrams (mg) midazolam administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15. |
| Part B2: LY3023414 + Fulvestrant | Experimental | Drug: LY3023414, Drug: FulvestrantLY3023414 administered orally BID for two 28 day cycles to participants with advanced/metastatic breast cancer; participants receiving benefit may continue until disease progression or discontinuation. 500 mg fulvestrant administered IM once every 28 days. |
| Part B3: LY3023414 | Experimental | Drug: LY3023414LY3023414 administered orally BID for two 21 day cycles to participants with malignant mesothelioma; participants receiving benefit may continue until disease progression or discontinuation. |
| Part B4: LY3023414 + pemetrexed/cisplatin | Experimental | Drug: LY3023414, Drug: Pemetrexed, Drug: CisplatinLY3023414 administered orally BID for two 21 day cycles to participants with malignant mesothelioma; participants receiving benefit may continue until disease progression or discontinuation. 500 mg/m2 pemetrexed and 75 mg/m2 administered IV once every 21 days. |
| Part B5: LY3023414 | Experimental | Drug: LY3023414LY3023414 administered orally BID for two 21 day cycles to participants with indolent non-Hodgkin's lymphoma; participants receiving benefit may continue until disease progression or discontinuation. |
| Part B6: LY3023414 | Experimental | Drug: LY3023414LY3023414 administered orally BID for two 21 day cycles to participants with squamous NSCLC; participants receiving benefit may continue until disease progression or discontinuation. |
| Part B7: LY3023414 + Abemaciclib + Letrozole | Experimental | Drug: LY3023414, Drug: Abemaciclib, Drug: LetrozoleLY3023414 administered orally BID with abemaciclib administered orally BID and letrozole administered orally once a day for two 28 day cycles to participants with breast cancer; participants receiving benefit may continue until disease progression or discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Parts A, A2 \& B1: Participants must have pathological evidence of a diagnosis of advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy
- Part B2: Participants must have advanced, recurrent, or metastatic breast cancer that is refractory to aromatase inhibitors (AI) with either disease recurrence or disease progression; must be hormone receptor positive (HR+) and human epidermal growth factor receptor 2 (HER2)-negative; must be of postmenopausal status or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist
- Part B3 only: Participants must have malignant pleural or peritoneal mesothelioma
- Part B4 only: Participants must have malignant pleural or peritoneal mesothelioma and appropriate candidate for treatment with cisplatin/pemetrexed; no prior systemic chemotherapy
- Part B5 only: Participants must have histologically confirmed diagnosis of B-cell iNHL, with histological subtype; prior treatment with ≥2 prior chemotherapy- or immunotherapy-based regimens for iNHL
Key exclusion criteria (12 listed)
- Have serious preexisting medical conditions
- Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required).
- Have known acute or chronic leukemia or current hematologic malignancies (except iNHL for patients in Part B5) that, in the judgment of the investigator and sponsor, may affect the interpretation of results
- Have an active fungal, bacterial, and/or known viral infection
- Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results (Part B only)
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 |
|---|---|---|
| LY3023414Administered orally. Dose of 20 to 600 mg, as determined in Part A. | Drug | Part A2: LY3023414 Twice Daily, Part A: LY3023414 Once Daily, Part B1 : LY3023414 + Midazolam, Part B2: LY3023414 + Fulvestrant, Part B3: LY3023414, Part B4: LY3023414 + pemetrexed/cisplatin, Part B5: LY3023414, Part B6: LY3023414, Part B7: LY3023414 + Abemaciclib + Letrozole |
| Midazolam0.2 mg administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15. | Drug | Part B1 : LY3023414 + Midazolam |
| Fulvestrant500 mg administered IM on Day 1 and Day 15 in cycle 1 and Day 1 every 28 days for additional cycles. | Drug | Part B2: LY3023414 + Fulvestrant |
| PemetrexedAlso: Alimta500 mg/m2 administered IV once on Day 1 every 21 days | Drug | Part B4: LY3023414 + pemetrexed/cisplatin |
| Cisplatin75 mg/m2 administered IV once on Day 1 every 21 days | Drug | Part B4: LY3023414 + pemetrexed/cisplatin |
| AbemaciclibAlso: LY2835219Administered orally | Drug | Part B7: LY3023414 + Abemaciclib + Letrozole |
| LetrozoleAdministered orally | Drug | Part B7: LY3023414 + Abemaciclib + Letrozole |
Primary outcome
Recommended Phase 2 dose
Time frame: Baseline to disease progression or participant discontinuation (estimated 9 weeks)
4 secondary outcomes
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: Predose up to 12 hours postdose
Pharmacokinetics: Time of maximal concentration
Time frame: Predose up to 12 hours postdose
Number of participants with tumor response
Time frame: Baseline to disease progression or participant discontinuation (estimated 9 weeks)
Potential of LY3023414 to inhibit CYP3A4-mediated metabolism
Time frame: Baseline through Cycle 1
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 8 Apr 2022.
- Derived from this study: PubMed 33660194Zauderer MG, Alley EW, Bendell J, Capelletto E, Bauer TM, Callies S, Szpurka AM, Kang S, Willard MD, Wacheck V, Varghese AM. Phase 1 cohort expansion study of LY3023414, a dual PI3K/mTOR inhibitor, in patients with advanced mesothelioma. Invest New Drugs. 2021 Aug;39(4):1081-1088. doi: 10.1007/s10637-021-01086-6. Epub 2021 Mar 4.
- A Study of LY3023414 in Participants With Advanced CancerLink provided by the sponsor.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3023414, Midazolam and Fulvestrant in people with Advanced Cancer and Metastatic Cancer, run by Eli Lilly and Company at 8 sites in 3 countries.
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 14 inclusion and 12 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 8 Apr 2022. 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, Italy, Puerto Rico. 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?
Recommended Phase 2 dose (time frame: Baseline to disease progression or participant discontinuation (estimated 9 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01655225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.