Non Small Cell Lung Cancer Squamous (NSCLC-Sq)Phase 1NCT03811652
A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors
A Phase 1 study testing MEDI7247 in people with Non Small Cell Lung Cancer Squamous (NSCLC-Sq) and Head and Neck Squamous Cell Carcinoma (HNSCC), run by MedImmune LLC at 3 sites in 2 countries.
Trial summary
To assess safety and tolerability, describe the dose-limiting toxicities, assess the preliminary antitumor activity, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of… Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Non Small Cell Lung Cancer Squamous (NSCLC-Sq), Head and Neck Squamous Cell Carcinoma (HNSCC), Small Cell Lung Cancer (SCLC)
- What is being tested?
- MEDI7247
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 20 Dec 2018to 10 Dec 2019
- 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 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of advanced or metastatic select solid tumors and either progression on or documented intolerance to standard therapies
- Age ≥ 18 years at the time of screening.
- Written informed consent and any locally required authorization
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- At least 1 measurable target lesion by CT or MRI per RECIST Version 1.1 (excluding mCRPC)
- Adequate Liver Function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (upper limit normal), Albumin > 3 g/dL, and serum total bilirubin (TBL) ≤ 1.5 × ULN; (unless bilirubin rise is due to Gilbert's syndrome, hepatic metastases or of non-hepatic origin, in which case TBL ≤ 3 × ULN is allowed)
Show all 11Show fewer
- Creatinine Clearance (CrCL) ≥ 40 mL/min
- Adequate Hematopoesis: Absolute Neutrophil Count (ANC) ≥ 1,500/μL, Platelets ≥ 100,000/μL, and Hgb ≥ 9 g/dL unassisted by transfusion or growth factor within 14 days of screening
- Provision of archival or fresh tumor tissue at screening
- Female patients of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception, and must agree to continue using such precautions for 90 days after the last dose of investigational product.
- Nonsterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 7 days post-screening and for 90 days after receipt of the last dose of investigational product.
Who cannot join
- Active central nervous system (CNS) metastases, unless adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) and prednisolone 10 mg or less for more than 2 weeks prior to enrollment. For SCLC, a brain MRI scan that was conducted ≤ 28 days from Day 1 is required.
- Residual toxicity from prior anticancer therapy not resolved to NCI CTCAE v4.03 Grade 1, with the exception of alopecia/vitiligo at the time of first dose of investigational product. For patients previously receiving immunotherapy, toxicities that are unlikely to recover to Grade 1.
- Royal Marsden Hospital (RMH) prognostic score 2 and 3 at baseline.
- Treatment with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 21 days, or prior palliative radiotherapy within 2 weeks of the first dose of investigational product.
- 5 Prior treatment with other Pyrrolobenzodiazepine-Antibody Drug Conjugates.
- 6 History of previous malignancies (except for locally curable cancers) unless a complete remission was achieved at least 3 years prior to study entry AND no additional therapy is required during the study period (except adjuvant hormonal therapy and bisphosphonate).
Show all 10Show fewer
- 7. Failure to recover from major surgery or significant traumatic injury within 21 days of first dose of study treatment.
- 8 History of hepatic sinusoidal obstruction syndrome, also called veno-occlusive disease 9. History of capillary leak syndrome. 10 Blood transfusion within 14 days of study entry except when needed for disease related anemia.
- 11. New York Heart Association classes III-IV congestive heart failure or serious cardiac arrhythmia requiring treatment, history of myocardial infarction, unstable angina, vascular stent, or coronary artery bypass graft within 6 months of the first dose of investigational product. 12. Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections at the time of screening.
- 13. Current severe active systemic disease including active concurrent malignancy 14. Pregnancy and/or breastfeeding at time of screening 15. Concurrent enrollment in anther clinical study involving an investigational treatment that is not an extension of another MedImmune study with the same investigational product.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Research Site
Huntersville, North Carolina, 28078
Research Site
Nashville, Tennessee, 37203
About this study
Official title: A Phase 1/1b Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI7247 in Patients With Advanced or Metastatic Disease in Selected Solid Tumors
To assess safety and tolerability, describe the dose-limiting toxicities, assess the preliminary antitumor activity, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected advanced or metastatic solid tumor malignancies that have received at least 1 prior line of treatment.
- Conditions
- Non Small Cell Lung Cancer Squamous (NSCLC-Sq), Head and Neck Squamous Cell Carcinoma (HNSCC), Small Cell Lung Cancer (SCLC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer (CRC), Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Being tested
- MEDI7247
- Keywords
- Medi7247, non small cell lung cancer, head and neck cancer, small cell lung cancer, colorectal cancer, prostate cancer, pancreatic adenocarcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Small Cell Lung Carcinoma, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI7247Drug
Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
| Study group | Role | What they receive |
|---|---|---|
| NSCLC-Sq/HNSCC | Experimental | Patients with advanced or metastatic NSCLC-Sq or HNSCC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen (platinum-based for HNSCC). PDL-1 positive patients should have received previous PD-1 or PD-L1 inhibitor where available. Receives: Drug: MEDI7247 |
| Small Cell Lung Cancer | Experimental | Patients with advanced SCLC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen. Receives: Drug: MEDI7247 |
| Colorectal Cancer | Experimental | Patients with metastatic adenocarcinoma of the colon or rectum who have received and have progressed, or have documented intolerance, on prior thymidylate synthase inhibitor (eg, 5-fluorouracil (5-FU), capecitabine, raltitrexed, tegafur-uracil (UFT), irinotecan, and oxaliplatin for metastatic disease. If patients progress within 6 months of their last dose of adjuvant therapy this should be considered as a line of therapy in the metastatic setting. Patients with known RAS wildtype tumors must have received and progressed, or have documented intolerance, on anti-EGFR antibody. Patients with microsatellite instability-high or deficient mismatch repair tumors, must have received and progressed, or have documented intolerance on a PD-1 inhibitor, or PD-1 inhibitor plus cytotoxic T-lymphocyte antigen-4 inhibitor treatment where available. Receives: Drug: MEDI7247 |
| Pancreatic Ductal Adenocarcinoma | Experimental | Patients with unresectable, locally advanced or metastatic PDAC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior line of treatment. Receives: Drug: MEDI7247 |
| Metastatic Castration-Resistant Prostate Cancer | Experimental | Patients with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting. Receives: Drug: MEDI7247 |
| Other advanced/metastatic target expressing solid tumors | Experimental | Patients with advanced or metastatic solid tumors not defined by other treatment arms who have positive expression of the protein target and have exhausted all approved therapies Receives: Drug: MEDI7247 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events
To assess the occurrence of adverse events
Measured: From time of informed consent through 90 days post end of treatment
Occurrence of Serious Adverse Events
To assess the occurrence of serious adverse events
Measured: From time of informed consent through 90 days post end of treatment
Occurrence of Dose Limiting Toxicities
To assess the occurrence of toxicities and abnormal laboratory results that may limit further dose administration
Measured: During the evaluation period of 21 days post first dose
Number of patients with changes in laboratory parameters from baseline
To assess serum chemistry, hematology, urinalysis and coagulation parameters
Measured: From time of informed consent through 90 days post end of treatment
Number of patients with changes in vital signs parameters from baseline
to assess changes in vital signs
Measured: from time of informed consent through 21 days post last dose
Number of patients with changes in electrocardiogram results from baseline
to assess changes in ECG
Measured: from time of informed consent through 21 days post last dose
Percentage of patients with changes in laboratory parameters from baseline
to assess changes in serum chemistry, hematology, urinalysis, and coagulation parameters
Measured: from time of informed consent through 90 days post end of treatment
Secondary outcomes (12)
MEDI7247 maximum observed concentration (Cmax)
To characterize MEDI7247 single agent Pharmacokinetics
Measured: From first dose through 90 days post end of treatment
MEDI7247 terminal half life (t1/2)
To characterize single agent MEDI7247 pharmacokinetics
Measured: From first dose through 90 days post end of treatment
MEDI7247 area under the concentration/time curve (AUC)
To characterize single agent MEDI7247 pharmacokinetics
Measured: from first dose through 90 days post end of treatment
MEDI7247 clearance
to characterize the single agent MEDI7247 pharmacokinetics
Measured: from first dose through 90 days post end of treatment
Number of subjects who develop anti-drug antibodies
To characterize MEDI7247 immunogenicity
Measured: first dose through 90 days post end of treatment
Best Overall Response
To assess antitumor activity of MEDI7247
Measured: From time of informed consent and up to 90 days post end of treatment
Objective Response Rate (ORR)
To assess antitumor activity of MEDI7247
Measured: From time of informed consent and up to 2 years after last subject in
Time to Response (TTR)
To assess antitumor activity of MEDI7247
Measured: From time of informed consent and up to 90 days post end of treatment
Duration of Response (DoR)
To assess antitumor activity of MEDI7247
Measured: From time of informed consent and up to 2 years after last subject in
Progression Free Survival (PFS)
To assess the antitumor activity of MEDI7247
Measured: From time of informed consent and up to 2 years after last subject in
Disease Control (DC)
To assess antitumor activity of MEDI7247
Measured: From time of informed consent and up to 2 years after last subject in
Overall Survival (OS)
To assess antitumor activity of MEDI7247
Measured: From time of informed consent and up to 2 years after last subject in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start20 Dec 2018
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer Squamous (NSCLC-Sq)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811652
- Sponsor's protocol ID
- D8540C00002
- Status last verified
- Dec 2019
- First submitted
- 21 Dec 2018
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI7247 in Patients With Advanced or Metastatic Disease in Selected Solid Tumors
- ClinicalTrials.gov ID
- NCT03811652
- Acronym / sponsor ID
- D8540C00002
- Conditions
- Non Small Cell Lung Cancer Squamous (NSCLC-Sq), Head and Neck Squamous Cell Carcinoma (HNSCC), Small Cell Lung Cancer (SCLC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer (CRC), Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Keywords
- Medi7247, non small cell lung cancer, head and neck cancer, small cell lung cancer, colorectal cancer, prostate cancer, pancreatic adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 22 Jan 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.
To assess safety and tolerability, describe the dose-limiting toxicities, assess the preliminary antitumor activity, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected advanced or metastatic solid tumor malignancies that have received at least 1 prior line of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NSCLC-Sq/HNSCC | Experimental | Drug: MEDI7247Patients with advanced or metastatic NSCLC-Sq or HNSCC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen (platinum-based for HNSCC). PDL-1 positive patients should have received previous PD-1 or PD-L1 inhibitor where available. |
| Small Cell Lung Cancer | Experimental | Drug: MEDI7247Patients with advanced SCLC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen. |
| Colorectal Cancer | Experimental | Drug: MEDI7247Patients with metastatic adenocarcinoma of the colon or rectum who have received and have progressed, or have documented intolerance, on prior thymidylate synthase inhibitor (eg, 5-fluorouracil (5-FU), capecitabine, raltitrexed, tegafur-uracil (UFT), irinotecan, and oxaliplatin for metastatic disease. If patients progress within 6 months of their last dose of adjuvant therapy this should be considered as a line of therapy in the metastatic setting. Patients with known RAS wildtype tumors must have received and progressed, or have documented intolerance, on anti-EGFR antibody. Patients with microsatellite instability-high or deficient mismatch repair tumors, must have received and progressed, or have documented intolerance on a PD-1 inhibitor, or PD-1 inhibitor plus cytotoxic T-lymphocyte antigen-4 inhibitor treatment where available. |
| Pancreatic Ductal Adenocarcinoma | Experimental | Drug: MEDI7247Patients with unresectable, locally advanced or metastatic PDAC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior line of treatment. |
| Metastatic Castration-Resistant Prostate Cancer | Experimental | Drug: MEDI7247Patients with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting. |
| Other advanced/metastatic target expressing solid tumors | Experimental | Drug: MEDI7247Patients with advanced or metastatic solid tumors not defined by other treatment arms who have positive expression of the protein target and have exhausted all approved therapies |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed diagnosis of advanced or metastatic select solid tumors and either progression on or documented intolerance to standard therapies
- Age ≥ 18 years at the time of screening.
- Written informed consent and any locally required authorization
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- At least 1 measurable target lesion by CT or MRI per RECIST Version 1.1 (excluding mCRPC)
Key exclusion criteria (10 listed)
- Active central nervous system (CNS) metastases, unless adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) and prednisolone 10 mg or less for more than 2 weeks prior to enrollment. For SCLC, a brain MRI scan that was conducted ≤ 28 days from Day 1 is required.
- Residual toxicity from prior anticancer therapy not resolved to NCI CTCAE v4.03 Grade 1, with the exception of alopecia/vitiligo at the time of first dose of investigational product. For patients previously receiving immunotherapy, toxicities that are unlikely to recover to Grade 1.
- Royal Marsden Hospital (RMH) prognostic score 2 and 3 at baseline.
- Treatment with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 21 days, or prior palliative radiotherapy within 2 weeks of the first dose of investigational product.
- 5 Prior treatment with other Pyrrolobenzodiazepine-Antibody Drug Conjugates.
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 |
|---|---|---|
| MEDI7247Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule | Drug | Colorectal Cancer, Metastatic Castration-Resistant Prostate Cancer, NSCLC-Sq/HNSCC, Other advanced/metastatic target expressing solid tumors, Pancreatic Ductal Adenocarcinoma, Small Cell Lung Cancer |
Primary outcome
Occurrence of Adverse Events
Time frame: From time of informed consent through 90 days post end of treatment
To assess the occurrence of adverse events
Occurrence of Serious Adverse Events
Time frame: From time of informed consent through 90 days post end of treatment
To assess the occurrence of serious adverse events
Occurrence of Dose Limiting Toxicities
Time frame: During the evaluation period of 21 days post first dose
To assess the occurrence of toxicities and abnormal laboratory results that may limit further dose administration
Number of patients with changes in laboratory parameters from baseline
Time frame: From time of informed consent through 90 days post end of treatment
To assess serum chemistry, hematology, urinalysis and coagulation parameters
Number of patients with changes in vital signs parameters from baseline
Time frame: from time of informed consent through 21 days post last dose
to assess changes in vital signs
Number of patients with changes in electrocardiogram results from baseline
Time frame: from time of informed consent through 21 days post last dose
to assess changes in ECG
Percentage of patients with changes in laboratory parameters from baseline
Time frame: from time of informed consent through 90 days post end of treatment
to assess changes in serum chemistry, hematology, urinalysis, and coagulation parameters
12 secondary outcomes
MEDI7247 maximum observed concentration (Cmax)
Time frame: From first dose through 90 days post end of treatment
MEDI7247 terminal half life (t1/2)
Time frame: From first dose through 90 days post end of treatment
MEDI7247 area under the concentration/time curve (AUC)
Time frame: from first dose through 90 days post end of treatment
MEDI7247 clearance
Time frame: from first dose through 90 days post end of treatment
Number of subjects who develop anti-drug antibodies
Time frame: first dose through 90 days post end of treatment
Best Overall Response
Time frame: From time of informed consent and up to 90 days post end of treatment
Objective Response Rate (ORR)
Time frame: From time of informed consent and up to 2 years after last subject in
Time to Response (TTR)
Time frame: From time of informed consent and up to 90 days post end of treatment
Duration of Response (DoR)
Time frame: From time of informed consent and up to 2 years after last subject in
Progression Free Survival (PFS)
Time frame: From time of informed consent and up to 2 years after last subject in
Disease Control (DC)
Time frame: From time of informed consent and up to 2 years after last subject in
Overall Survival (OS)
Time frame: From time of informed consent and up to 2 years after last subject in
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 30 Dec 2019.
Related trials for Non Small Cell Lung Cancer Squamous (NSCLC-Sq)
Not yet recruitingPhase 1
Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients
Squamous Non-Small Cell Lung Cancer sqNSCLC
RecruitingPhase 1
A Study of HDM2020 in Patients With Advanced Sq-NSCLC
Squamous Non-small Cell Lung Cancer(NSCLC)
Not yet recruitingPhase 3
Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer
Squamous 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI7247 in people with Non Small Cell Lung Cancer Squamous (NSCLC-Sq) and Head and Neck Squamous Cell Carcinoma (HNSCC), run by MedImmune LLC at 3 sites in 2 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 11 inclusion and 10 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 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
Occurrence of Adverse Events (time frame: From time of informed consent through 90 days post end of treatment). The study lists 7 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 30 Dec 2019.