Breast CancerPhase 1NCT04261218
Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of Tomivosertib Combined With Paclitaxel in Advanced Breast Cancer
A Phase 1 study testing tomivosertib and paclitaxel in people with Breast Cancer, run by Translational Research in Oncology at 3 sites in Canada.
Trial summary
This is a multicenter, open-label trial to evaluate the safety, pharmacodynamics (PD), pharmacokinetics (PK), and efficacy of tomivosertib in combination with paclitaxel in patients with advanced breast cancer (ABC) of any subtype. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- tomivosertib and paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesCanada
- Study dates
- 25 Aug 2020to 4 Jul 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
- Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure.
- Women or men aged ≥ 18 years-old on the day of the written informed consent is given.
- Histologically or cytologically confirmed breast adenocarcinoma that is either metastatic (stage IV of the TNM classification) or locally recurrent and not amenable to local curative treatment.
- Known ER, PgR and HER2 statuses (note: the BC subtype at trial entry will be determined by the statuses in the most recent sample(s) tested for ER, PgR and HER2).
- Evidence of measurable disease (according to RECIST v.1.1) based on imaging studies and/or physical examination.
- Patient is a candidate for weekly paclitaxel as palliative treatment for the locally recurrent and/or metastatic disease in the opinion of the treating physician, or is currently receiving paclitaxel (achieving disease control or not). Note: any number of prior lines of standard-of-care or experimental therapies are allowed.
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- At least one metastatic (or recurrent) lesion that is amenable to repeated biopsy and willingness and ability to undergo two biopsies (at screening and approximately 2 weeks after the start of trial treatment).
- ECOG performance status of 0, 1 or 2.
- Life expectancy of ≥ 6 months per Investigator's judgement.
- Adequate organ function during screening, as defined below:
- Hemoglobin ≥8.0 g/dL (criterion must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 2 weeks)
- Absolute neutrophil count ≥1,500 cells/mm3
- Platelet count ≥100,000 cells/mm3
- Total bilirubin ≤1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
- Aspartate aminotransferase and alanine aminotransferase ≤3 × ULN (≤5 × ULN for patients with liver metastases)
- Measured or calculated creatinine clearance (CrCl) >60 mL/min (if calculated, it should be done using the Cockcroft-Gault formula)
- For women of childbearing potential (WoCBP) - must meet all of the following criteria:
- Not pregnant (negative serum pregnancy within 14 days of enrollment), and
- Not breastfeeding, and
- Willing to use a protocol-recommended method of contraception (refer to details within protocol), from the start of tomivosertib until at least 30 days after the last dose of trial treatment.
- Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation/occlusion, or bilateral oophorectomy, has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range), or is postmenopausal. Post-menopausal status is defined as 12 consecutive months with no menses without an alternative medical cause.
- For sexually active male subjects who can father a child - must be willing to refrain from sperm donation and to use a protocol-recommended method of contraception (detailed within protocol), from the start of tomivosertib until at least 74 days after the last dose of trial treatment.
- Willing and able to comply with the scheduled visits, drug administration plan, protocol-specified laboratory tests, other trial procedures, and trial restrictions. Note: psychological, social, familial, or geographical factors that might preclude adequate trial participation should be considered.
Who cannot join
- Current evidence of incomplete recovery from clinically-significant toxicities associated with prior anti-cancer treatment(s), that would represent a contra-indication to experimental therapy in the opinion of the Investigator.
- Prior systemic standard or investigational anti-cancer therapy within 3 weeks prior to enrollment and/or major surgery within 2 weeks prior to enrollment.
- Known symptomatic brain metastases requiring ≥10 mg/day of prednisolone (or its equivalent). Patients 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, fulfill the steroid requirement and are neurologically stable.
- Active infection requiring systemic therapy.
- Gastrointestinal disease that may interfere with drug absorption or with interpretation of gastrointestinal adverse events (e.g., gastric or intestinal bypass surgery, pancreatic enzyme insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic diarrheal illness, bowel obstruction).
- Significant cardiovascular disease including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 8 weeks prior to the start of tomivosertib; unstable dysrhythmias or other known clinically significant electrocardiogram abnormality; unstable angina; New York Heart Association Class 3 or 4 congestive heart failure; uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥180 mmHg); or history of congenital prolonged QT syndrome.
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- Prior therapy with any inhibitor of MNK1 and/or MNK2.
- Have used a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4, CYP2C9, CYP2D6, or CYP1A2 within 7 days prior to randomization or are expected to require use of a strong inhibitor or inducer of CYP3A4, CYP2C9, CYP2D6, or CYP1A2 during study participation.
- Known or suspected hypersensitivity to the trial drugs or excipients contained in the trial drugs.
- 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 malignancy currently in complete remission for ≥2 years.
- History or current evidence of any other medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the Investigator, will increase the risks associated with trial participation, or require treatments that will interfere with the conduct of the trial or the interpretation of trial results.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during her trial participation.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Jewish General Hospital
Montreal, Quebec, H3T 1E2
British Columbia Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Trial to Assess the Safety, Pharmacodynamic Effects, Pharmacokinetics and Efficacy of the MNK Inhibitor Tomivosertib (eFT508) in Combination With Paclitaxel, Following a Run-in Period of Tomivosertib Monotherapy, in Patients With Advanced Breast Cancer
This is a multicenter, open-label trial to evaluate the safety, pharmacodynamics (PD), pharmacokinetics (PK), and efficacy of tomivosertib in combination with paclitaxel in patients with advanced breast cancer (ABC) of any subtype.
The trial will enroll up to 45 patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 with any breast cancer (BC) subtype and at least one measurable lesion, for whom standard-of-care treatments are ineffective, not tolerated or were refused.
Read more
All patients will be initially treated with tomivosertib for 14 days (referred as the run-in period). Once treatment samples are obtained, weekly paclitaxel will be added to the treatment regimen.
Tumor assessments will be done at screening and then periodically throughout trial treatment. Patients will continue to receive trial treatment until progressive disease, as defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, intolerable trial-treatment-related toxicity, consent withdrawal, or other criteria is met (defined within the trial protocol).
- Conditions
- Breast Cancer
- Being tested
- tomivosertib, paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tomivosertibDrug
Also called eFT508
Tomivoserib is supplied as a 100 mg capsule, to be taken orally.
paclitaxelDrug
Taken weekly according to the current market label in combination with experimental tomivosertib.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Dose Finding | Experimental | The first 3 patients enrolled in Group 1 will receive tomivosertib at a dose of 100 mg orally twice daily (BID), under fasting conditions, and will be assessed for dose limiting toxicities (DLTs) during this 'run-in' period. They will also receive the first cycle of tomivosertib IN COMBINATION with weekly paclitaxel in the 'post run-in' period. Depending on the occurrence/absence of DLTs, this first group of 3 patients may need to be expanded (up to 9 patients) or the trial may proceed to start enrollment in Group 2 (detailed in the arm below). Receives: Drug: tomivosertib; Drug: paclitaxel |
| Group 2 - Dose Expansion | Experimental | It is anticipated that Group 2 patients will receive tomivosertib at a dose of 100 mg orally twice daily (BID) during the 'run-in' period, which is taken in combination with weekly paclitaxel (according to market label) during the 'post run-in' period. Receives: Drug: tomivosertib; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Adverse Events (AEs)
The assessment of safety will be based mainly on the frequency of non-serious and serious AEs. The Medical Dictionary for Regulatory Activities will be used to code all AEs to a system organ class and a preferred term. Incidence of AEs will be tabulated by system organ class, preferred term and toxicity grade. Each of these outputs will include for each AE, system organ class and preferred term as reported by the Investigator based on Common Terminology Criteria for Adverse Events (NCI CTCAE). Detailed listings for all adverse events will also be provided.
Measured: Every serious adverse event (SAE) and related AE, following informed consent and at least until the '30-day safety follow-up' visit, will be assessed. All AEs during treatment will also be included.
Change from Baseline Pharmacodynamic Effects (PD) Following 14 Days of Tomivosertib Monotherapy
The PD evaluations to be performed will include endpoints related to both direct anti-neoplastic and immunomodulatory actions of the drug. A patient will be considered to have a response if one or more of the PD endpoints (listed in the lab manual) differ between baseline and on-study. The PD response rate will be calculated as the percentage of the patients in the PD Population for whom a PD response is observed.
Measured: All enrolled patients will undergo the sampling for PD assessments during screening and after 14 days (± 2 days) of tomivosertib monotherapy.
Secondary outcomes (3)
Overall Response Rate (ORR)
ORR is defined as the proportion of patients who have a complete response or partial response according to RECIST v.1.1, based on the Investigator's assessment.
Measured: Tumor assessments used to determine ORR will be conducted at screening and every 8 ± 2 weeks from the enrollment date for 12 months, then every 12 ± 2 weeks, until progressive disease, consent withdrawal, or death.
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of patients who have a complete response or partial response or stable disease according to RECIST v.1.1, based on the Investigator's assessment.
Measured: Tumor assessments used to determine CBR will be conducted at screening and every 8 ± 2 weeks from the enrollment date for 12 months, then every 12 ± 2 weeks, until progressive disease, consent withdrawal, or death.
Pharmacokinetic Effects (PK)
Plasma concentrations of tomivosertib and paclitaxel will be determined using validated liquid chromatography tandem-mass spectrometry assays. Plasma concentrations will be summarized by scheduled time point with descriptive statistics, which will include the n, mean, standard deviation, coefficient of variation (%), median, minimum, and maximum.
Measured: All patients from Group 1 and 5-8 patients from Group 2 will be considered as the PK subset. Plasma samples will be obtained at the pre-determined time points during cycle 2 - days 1 and 2. Following cycle 1, treatment cycles are 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start25 Aug 2020
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Sequential
- Model description
- All patients will be initially treated with tomivosertib monotherapy for 14 ± 2 days (the run-in period). Once the on-treatment samples for pharmacodynamic (PD) assessments are obtained, weekly paclitaxel will be added to the treatment regimen. The first 3 to 9 patients will be part of Group 1. The first 3 patients enrolled in this group will receive tomivosertib at a dose of 100 mg orally twice daily (BID), in fasting conditions, and will be assessed for dose-limiting toxicities (DLTs) during the first cycle of tomivosertib in combination with paclitaxel. Depending on the occurrence/absence of DLTs, this first group of 3 patients may need to be expanded (up to 9 patients) or the trial may proceed to start enrollment in Group 2. Group 2 patients will receive tomivosertib at a dose of 100 mg orally BID during the 'run-in' period, as well as weekly paclitaxel in combination with tomivosertib during the 'post run-in' period.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Effector Therapeutics, Stand Up To Cancer
- Responsible party
- Sponsor
- Investigators
- Michael Pollak, MD, Study chair, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261218
- Sponsor's protocol ID
- TRIO036
- Status last verified
- Jul 2022
- First submitted
- 30 Jan 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Assess the Safety, Pharmacodynamic Effects, Pharmacokinetics and Efficacy of the MNK Inhibitor Tomivosertib (eFT508) in Combination With Paclitaxel, Following a Run-in Period of Tomivosertib Monotherapy, in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04261218
- Acronym / sponsor ID
- TRIO036
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Translational Research in OncologyUniversity, hospital or other
- Collaborators
- Effector Therapeutics, Stand Up To Cancer
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label trial to evaluate the safety, pharmacodynamics (PD), pharmacokinetics (PK), and efficacy of tomivosertib in combination with paclitaxel in patients with advanced breast cancer (ABC) of any subtype.
The trial will enroll up to 45 patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 with any breast cancer (BC) subtype and at least one measurable lesion, for whom standard-of-care treatments are ineffective, not tolerated or were refused.
All patients will be initially treated with tomivosertib for 14 days (referred as the run-in period). Once treatment samples are obtained, weekly paclitaxel will be added to the treatment regimen.
Tumor assessments will be done at screening and then periodically throughout trial treatment. Patients will continue to receive trial treatment until progressive disease, as defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, intolerable trial-treatment-related toxicity, consent withdrawal, or other criteria is met (defined within the trial protocol).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients will be initially treated with tomivosertib monotherapy for 14 ± 2 days (the run-in period). Once the on-treatment samples for pharmacodynamic (PD) assessments are obtained, weekly paclitaxel will be added to the treatment regimen. The first 3 to 9 patients will be part of Group 1. The first 3 patients enrolled in this group will receive tomivosertib at a dose of 100 mg orally twice daily (BID), in fasting conditions, and will be assessed for dose-limiting toxicities (DLTs) during the first cycle of tomivosertib in combination with paclitaxel. Depending on the occurrence/absence of DLTs, this first group of 3 patients may need to be expanded (up to 9 patients) or the trial may proceed to start enrollment in Group 2. Group 2 patients will receive tomivosertib at a dose of 100 mg orally BID during the 'run-in' period, as well as weekly paclitaxel in combination with tomivosertib during the 'post run-in' period.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Dose Finding | Experimental | Drug: tomivosertib, Drug: paclitaxelThe first 3 patients enrolled in Group 1 will receive tomivosertib at a dose of 100 mg orally twice daily (BID), under fasting conditions, and will be assessed for dose limiting toxicities (DLTs) during this 'run-in' period. They will also receive the first cycle of tomivosertib IN COMBINATION with weekly paclitaxel in the 'post run-in' period. Depending on the occurrence/absence of DLTs, this first group of 3 patients may need to be expanded (up to 9 patients) or the trial may proceed to start enrollment in Group 2 (detailed in the arm below). |
| Group 2 - Dose Expansion | Experimental | Drug: tomivosertib, Drug: paclitaxelIt is anticipated that Group 2 patients will receive tomivosertib at a dose of 100 mg orally twice daily (BID) during the 'run-in' period, which is taken in combination with weekly paclitaxel (according to market label) during the 'post run-in' period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure.
- Women or men aged ≥ 18 years-old on the day of the written informed consent is given.
- Histologically or cytologically confirmed breast adenocarcinoma that is either metastatic (stage IV of the TNM classification) or locally recurrent and not amenable to local curative treatment.
- Known ER, PgR and HER2 statuses (note: the BC subtype at trial entry will be determined by the statuses in the most recent sample(s) tested for ER, PgR and HER2).
- Evidence of measurable disease (according to RECIST v.1.1) based on imaging studies and/or physical examination.
Key exclusion criteria (12 listed)
- Current evidence of incomplete recovery from clinically-significant toxicities associated with prior anti-cancer treatment(s), that would represent a contra-indication to experimental therapy in the opinion of the Investigator.
- Prior systemic standard or investigational anti-cancer therapy within 3 weeks prior to enrollment and/or major surgery within 2 weeks prior to enrollment.
- Known symptomatic brain metastases requiring ≥10 mg/day of prednisolone (or its equivalent). Patients 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, fulfill the steroid requirement and are neurologically stable.
- Active infection requiring systemic therapy.
- Gastrointestinal disease that may interfere with drug absorption or with interpretation of gastrointestinal adverse events (e.g., gastric or intestinal bypass surgery, pancreatic enzyme insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic diarrheal illness, bowel obstruction).
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 |
|---|---|---|
| tomivosertibAlso: eFT508Tomivoserib is supplied as a 100 mg capsule, to be taken orally. | Drug | Group 1 - Dose Finding, Group 2 - Dose Expansion |
| paclitaxelTaken weekly according to the current market label in combination with experimental tomivosertib. | Drug | Group 1 - Dose Finding, Group 2 - Dose Expansion |
Primary outcome
Number of Patients with Adverse Events (AEs)
Time frame: Every serious adverse event (SAE) and related AE, following informed consent and at least until the '30-day safety follow-up' visit, will be assessed. All AEs during treatment will also be included.
The assessment of safety will be based mainly on the frequency of non-serious and serious AEs. The Medical Dictionary for Regulatory Activities will be used to code all AEs to a system organ class and a preferred term. Incidence of AEs will be tabulated by system organ class, preferred term and toxicity grade. Each of these outputs will include for each AE, system organ class and preferred term as reported by the Investigator based on Common Terminology Criteria for Adverse Events (NCI CTCAE). Detailed listings for all adverse events will also be provided.
Change from Baseline Pharmacodynamic Effects (PD) Following 14 Days of Tomivosertib Monotherapy
Time frame: All enrolled patients will undergo the sampling for PD assessments during screening and after 14 days (± 2 days) of tomivosertib monotherapy.
The PD evaluations to be performed will include endpoints related to both direct anti-neoplastic and immunomodulatory actions of the drug. A patient will be considered to have a response if one or more of the PD endpoints (listed in the lab manual) differ between baseline and on-study. The PD response rate will be calculated as the percentage of the patients in the PD Population for whom a PD response is observed.
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: Tumor assessments used to determine ORR will be conducted at screening and every 8 ± 2 weeks from the enrollment date for 12 months, then every 12 ± 2 weeks, until progressive disease, consent withdrawal, or death.
Clinical Benefit Rate (CBR)
Time frame: Tumor assessments used to determine CBR will be conducted at screening and every 8 ± 2 weeks from the enrollment date for 12 months, then every 12 ± 2 weeks, until progressive disease, consent withdrawal, or death.
Pharmacokinetic Effects (PK)
Time frame: All patients from Group 1 and 5-8 patients from Group 2 will be considered as the PK subset. Plasma samples will be obtained at the pre-determined time points during cycle 2 - days 1 and 2. Following cycle 1, treatment cycles are 28 days.
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 20 Jul 2022.
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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.
Michael Pollak, MD study chair
McGill University
3 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 tomivosertib and paclitaxel in people with Breast Cancer, run by Translational Research in Oncology at 3 sites in Canada.
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 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 20 Jul 2022. 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 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?
Number of Patients with Adverse Events (AEs) (time frame: Every serious adverse event (SAE) and related AE, following informed consent and at least until the '30-day safety follow-up' visit, will be assessed. All AEs during treatment will also be included.). 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 20 Jul 2022.