Solid TumorsPhase 2NCT03616834
Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy
A Phase 2 study testing Tomivosertib (eFT-508) in people with Solid Tumors, run by Effector Therapeutics at 19 sites in United States.
Trial summary
Phase 2, open-label study that will evaluate the safety, tolerability, antitumor activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Tomivosertib (eFT-508)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 19 sitesUnited States
- Study dates
- 25 Jul 2018to 30 Jun 2021
- Phase
- Phase 2
- 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
- Must provide written informed consent and any authorizations required by local law;
- Men or women 18 years of age;
- Initiated monotherapy with an anti-PD-1 or anti-PD-L1 agent (avelumab, atezolizumab, durvalumab, nivolumab, or pembrolizumab) in accordance with the package insert, and:
- Are judged by the Principal Investigator as tolerating the anti-PD-1 or anti-PD-L1 therapy, and
- Developed PD per RECIST 1.1 on therapy, or
- Have undergone 12 weeks of anti-PD-1 or anti-PD-L1 therapy with no evidence of PR or CR;
Show all 34Show fewer
- ECOG performance status of 0 or 1;
- Has at least 1 measurable lesion per RECIST 1.1 criteria;
- Adequate bone marrow function during Screening as defined below:
- Absolute neutrophil count 1.0 109/L,
- Platelet count 75 109/L, and
- Hemoglobin 80 g/L (8.0 g/dL or 4.9 mmol/L);
- Adequate hepatic function during Screening as defined below:
- Serum alanine aminotransferase 3 upper limit of normal (ULN) or 5 ULN if liver metastases are present,
- Serum aspartate aminotransferase 3 ULN or 5 ULN if liver metastases are present, and
- Serum bilirubin - total 1.5 ULN (unless due to Gilbert's syndrome or hemolysis);
- Adequate renal function during Screening, defined as measured or estimated creatinine clearance 60 mL/min calculated by the Cockcroft-Gault formula using actual body weight;
- Adequate coagulation profile during Screening as defined below:
- Prothrombin time within the ULN, and
- Activated partial thromboplastin time within the ULN;
- Negative antiviral serology during Screening as defined below:
- Negative human immunodeficiency virus antibody,
- Negative hepatitis B surface antigen and negative hepatitis B core antibody or undetectable hepatitis B virus (HBV) DNA by quantitative polymerase chain reaction (qPCR) testing. Note: Hepatocellular carcinoma (HCC) subjects with - -- HBV may only be enrolled if their hepatitis is judged clinically stable by the Investigator, and
- Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid by q PCR. Note: HCC subjects with HCV are permitted provided they are not being actively treated;
- Female subjects of childbearing potential must meet all of the following criteria:
- Not pregnant (negative serum pregnancy test during Screening),
- Not breastfeeding, and
- Willing to use a protocol-recommended method of contraception or to abstain from heterosexual intercourse from the start of Tomivosertib (eFT-508) until at least 30 days after the last dose of Tomivosertib (eFT-508) or anti-PD-1/anti-PD-L1 therapy. Note: A female subject is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine beta human chorionic gonadotropin); or is menopausal (age 55 years with amenorrhea for 6 months);
- Male subjects who can father a child must meet all of the following criteria:
- Willing to use a protocol-recommended method of contraception or to abstain from heterosexual intercourse with females of childbearing potential from the start of Tomivosertib (eFT-508) until at least 30 days after the last dose of Tomivosertib (eFT-508) or anti-PD-1/anti-PD-L1 therapy, and
- Willing to refrain from sperm donation from the start of Tomivosertib (eFT-508) until at least 90 days after the last dose of Tomivosertib (eFT-508) or anti-PD-1/anti-PD-L1 therapy. Note: A - male subject is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy;
- Willing to comply with the scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. Note: Psychological, social, familial, or geographical factors that might preclude adequate study participation should be considered;
- In the judgment of the Investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer; and
- Estimated life expectancy of 3 months.
Who cannot join
- Currently in CR or PR with anti-PD-1 or anti-PD-L1 monotherapy (avelumab, atezolizumab, durvalumab, nivolumab, or pembrolizumab);
- History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission; or any other cancer that has been in complete remission for 2 years
- Gastrointestinal (GI) disease (eg, gastric or intestinal bypass surgery, pancreatic enzyme insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic diarrheal illness, bowel obstruction) that may interfere with drug absorption or with interpretation of GI AEs;
- Known symptomatic brain metastases requiring 10 mg/day of prednisolone (or its equivalent). Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of Tomivosertib (eFT-508), fulfill the steroid requirement for these metastases, and are neurologically stable;
- Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months prior to start of Tomivosertib (eFT-508); symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; Grade 3 hypertension (diastolic blood pressure 100 mmHg or systolic blood pressure 160 mmHg); or history of congenital prolonged QT syndrome;
- Significant ECG abnormalities at Screening, including unstable cardiac arrhythmia requiring medication, left bundle branch block, second-degree atrioventricular (AV) block type II, third-degree AV block, Grade 2 bradycardia, or QT interval corrected using Fridericia's formula >450 msec (for men) or >470 msec (for women);
Show all 22Show fewer
- Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis;
- Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the start of Tomivosertib (eFT-508). Note: Subjects with localized fungal infections of skin or nails are eligible. Subjects may be receiving prophylactic antibiotics as long as the antibiotic is not prohibited by the protocol due to the potential for drug-drug interactions;
- Has received a live vaccine within 30 days of planned start of Tomivosertib (eFT-508);
- Pregnant or breastfeeding;
- Major surgery within 4 weeks before the start of Tomivosertib (eFT-508);
- Prior solid organ or bone marrow progenitor cell transplantation;
- Prior therapy with any known inhibitor of MNK1 or MNK2;
- Prior high-dose chemotherapy requiring stem cell rescue;
- History of or active autoimmune disorders or other conditions that might impair or compromise the immune system;
- Any prior exposure to cytotoxic T-lymphocyte-associated protein 4 inhibitors;
- Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids. Note: At Screening and during study participation, subjects may be using systemic corticosteroids (doses 10 mg of prednisone or equivalent) or topical or inhaled corticosteroids;
- Use of a strong inhibitor or inducer of cytochrome P450 (CYP)3A4 within 7 days prior to the start of Tomivosertib (eFT-508) or expected requirement for use of a strong CYP3A4 inhibitor or inducer during study participation; Need for proton pump inhibitors and histamine H2 blockers at study entry;
- Previously received investigational product in a clinical trial within 30 days or within 5 elimination half-lives (whichever is longer) prior to the start of Tomivosertib (eFT-508), or is planning to take part in another clinical trial while participating in this study;
- Has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign Informed - Consent Document(s), adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results;
- Portal vein invasion at the main portal (Vp4), inferior vena cava, or cardiac - involvement of HCC based on imaging; or
- Has had esophageal or gastric variceal bleeding within the last 6 months.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
Gabrail Cancer Center
Canton, Ohio, 44718
Columbus Regional Research Institute
Columbus, Georgia, 31904
Karmanos Cancer Institute
Detroit, Michigan, 48201
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Oncology Consultants
Houston, Texas, 77024
Indiana University Health Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Pacific Shores Medical Group
Long Beach, California, 90813
Hoag Memorial Hospital Presbyterian
Los Angeles, California, 90033
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
Providence Portland Medical Center
Portland, Oregon, 97213
St. Mary's Medical Center
San Francisco, California, 94117
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Universty of Toledo Medical Center
Toledo, Ohio, 43614
University of Arizona - Cancer Center
Tucson, Arizona, 85724
About this study
Official title: Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy: A Study of Subjects Administered Anti-PD-1/Anti-PD-L1 Therapy That Are Experiencing Insufficient Response to Checkpoint Inhibitor Alone
Phase 2, open-label study that will evaluate the safety, tolerability, antitumor activities.
Read the detailed description
This Phase 2, open-label study will evaluate the safety, tolerability, antitumor activity, and pharmacokinetics (PK) of Tomivosertib (eFT-508) in subjects who have initiated anti-PD-1/anti-PD-L1 monotherapy and either developed progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 on therapy or have undergone 12 weeks of anti-PD-1/anti-PD-L1 therapy with no evidence of partial response (PR) or complete response (CR).
- Conditions
- Solid Tumors
- Being tested
- Tomivosertib (eFT-508)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomivosertib (eFT-508)Drug
Also called MNK1 and MNK2
Tomivosertib (eFT-508) is a novel, small-molecule investigational drug being developed by eFFECTOR Therapeutics, as an antitumor therapy that acts by selectively inhibiting mitogen-activated protein kinase (MAPK)-interacting serine/threonine kinase (MNK)1 and MNK 2.
| Study group | Role | What they receive |
|---|---|---|
| Tomivosertib (eFT-508) | Experimental | Tomivosertib (eFT-508) will be taken at 200 mg twice daily (bid). Subjects will continue their anti-PD-1/anti-PD-L1 therapy, which they had already initiated per standard of care according to the package insert. Receives: Drug: Tomivosertib (eFT-508) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with treatment-emergent AEs (TEAEs) and serious AEs (SAEs)
The incidence of TEAEs and SAEs will be summarized and TEAEs will also be summarized by severity and according to their relationship to Tomivosertib (eFT-508).
Measured: 52 weeks
Overall Response Rate (ORR) as determined by RECIST 1.1
Defined as the proportion of subjects who achieve a best overall response of complete response (CR) or partial response (PR).
Measured: 52 weeks
Progression Free Survival (PFS) as determined by RECIST 1.1
Defined as the interval from the start of Tomivosertib (eFT-508) to the occurrence of PD or death from any cause.
Measured: 52 weeks
Secondary outcomes (3)
ORR as determined by iRECIST
Defined as the proportion of subjects who achieve a best overall response of CR assigned using iRECIST (iCR) or PR assigned using iRECIST (iPR).
Measured: 52 weeks
PFS as determined by iRECIST
Defined as the interval from the start of Tomivosertib (eFT-508) to the occurrence of confirmed progression assigned using iRECIST (iCPD) or death from any cause.
Measured: 52 weeks
Overall survival
Defined as time from the first dose date of Tomivosertib (eFT-508) to death due to any cause will be summarized.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start25 Jul 2018
- Primary completion31 Jan 2021
- Study completion30 Jun 2021
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 Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will continue their anti-PD-1/anti-PD-L1 therapy, which they had already initiated per standard of care according to the package insert, and then initiate Tomivosertib (eFT-508) at 200 mg twice daily (bid) 7 days prior to their next scheduled anti-PD-1/anti-PD-L1 therapy.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Effector Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyon Gleich, MD, Study director, Medpace, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616834
- Sponsor's protocol ID
- eFT508-0010
- Status last verified
- Dec 2019
- First submitted
- 9 Jul 2018
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucibello G, Mograbi B, Milano G, Hofman P, Brest P. PD-L1 regulation revisited: impact on immunotherapeutic strategies. Trends Mol Med. 2021 Sep;27(9):868-881. doi: 10.1016/j.molmed.2021.06.005. Epub 2021 Jun 26.
PubMed 34187739
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy: A Study of Subjects Administered Anti-PD-1/Anti-PD-L1 Therapy That Are Experiencing Insufficient Response to Checkpoint Inhibitor Alone
- ClinicalTrials.gov ID
- NCT03616834
- Acronym / sponsor ID
- eFT508-0010
- Conditions
- Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Effector TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Aug 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.
Phase 2, open-label study that will evaluate the safety, tolerability, antitumor activities.
Detailed description
This Phase 2, open-label study will evaluate the safety, tolerability, antitumor activity, and pharmacokinetics (PK) of Tomivosertib (eFT-508) in subjects who have initiated anti-PD-1/anti-PD-L1 monotherapy and either developed progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 on therapy or have undergone 12 weeks of anti-PD-1/anti-PD-L1 therapy with no evidence of partial response (PR) or complete response (CR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will continue their anti-PD-1/anti-PD-L1 therapy, which they had already initiated per standard of care according to the package insert, and then initiate Tomivosertib (eFT-508) at 200 mg twice daily (bid) 7 days prior to their next scheduled anti-PD-1/anti-PD-L1 therapy.
| Arm | Type | Receives |
|---|---|---|
| Tomivosertib (eFT-508) | Experimental | Drug: Tomivosertib (eFT-508)Tomivosertib (eFT-508) will be taken at 200 mg twice daily (bid). Subjects will continue their anti-PD-1/anti-PD-L1 therapy, which they had already initiated per standard of care according to the package insert. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Must provide written informed consent and any authorizations required by local law;
- Men or women 18 years of age;
- Initiated monotherapy with an anti-PD-1 or anti-PD-L1 agent (avelumab, atezolizumab, durvalumab, nivolumab, or pembrolizumab) in accordance with the package insert, and:
- Are judged by the Principal Investigator as tolerating the anti-PD-1 or anti-PD-L1 therapy, and
- Developed PD per RECIST 1.1 on therapy, or
Key exclusion criteria (22 listed)
- Currently in CR or PR with anti-PD-1 or anti-PD-L1 monotherapy (avelumab, atezolizumab, durvalumab, nivolumab, or pembrolizumab);
- History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission; or any other cancer that has been in complete remission for 2 years
- Gastrointestinal (GI) disease (eg, gastric or intestinal bypass surgery, pancreatic enzyme insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic diarrheal illness, bowel obstruction) that may interfere with drug absorption or with interpretation of GI AEs;
- Known symptomatic brain metastases requiring 10 mg/day of prednisolone (or its equivalent). Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of Tomivosertib (eFT-508), fulfill the steroid requirement for these metastases, and are neurologically stable;
- Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months prior to start of Tomivosertib (eFT-508); symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; Grade 3 hypertension (diastolic blood pressure 100 mmHg or systolic blood pressure 160 mmHg); or history of congenital prolonged QT syndrome;
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 |
|---|---|---|
| Tomivosertib (eFT-508)Also: MNK1 and MNK2Tomivosertib (eFT-508) is a novel, small-molecule investigational drug being developed by eFFECTOR Therapeutics, as an antitumor therapy that acts by selectively inhibiting mitogen-activated protein kinase (MAPK)-interacting serine/threonine kinase (MNK)1 and MNK 2. | Drug | Tomivosertib (eFT-508) |
Primary outcome
Proportion of subjects with treatment-emergent AEs (TEAEs) and serious AEs (SAEs)
Time frame: 52 weeks
The incidence of TEAEs and SAEs will be summarized and TEAEs will also be summarized by severity and according to their relationship to Tomivosertib (eFT-508).
Overall Response Rate (ORR) as determined by RECIST 1.1
Time frame: 52 weeks
Defined as the proportion of subjects who achieve a best overall response of complete response (CR) or partial response (PR).
Progression Free Survival (PFS) as determined by RECIST 1.1
Time frame: 52 weeks
Defined as the interval from the start of Tomivosertib (eFT-508) to the occurrence of PD or death from any cause.
3 secondary outcomes
ORR as determined by iRECIST
Time frame: 52 weeks
PFS as determined by iRECIST
Time frame: 52 weeks
Overall survival
Time frame: 52 weeks
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 22 Mar 2023.
- Derived from this study: PubMed 34187739Lucibello G, Mograbi B, Milano G, Hofman P, Brest P. PD-L1 regulation revisited: impact on immunotherapeutic strategies. Trends Mol Med. 2021 Sep;27(9):868-881. doi: 10.1016/j.molmed.2021.06.005. Epub 2021 Jun 26.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
Not yet recruitingPhase 1
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
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.
Lyon Gleich, MD study director
Medpace, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tomivosertib (eFT-508) in people with Solid Tumors, run by Effector Therapeutics at 19 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 34 inclusion and 22 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Proportion of subjects with treatment-emergent AEs (TEAEs) and serious AEs (SAEs) (time frame: 52 weeks). The study lists 3 primary outcomes in all. 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 NCT03616834, 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 22 Mar 2023.