Relapsed or Refractory Acute Myeloid Leukemia (AML)Phase 1NCT03218683
Study of AZD5991 Alone or in Combination With Venetoclax in Relapsed or Refractory Haematologic Malignancies.
A Phase 1 study testing AZD5991 and AZD5991 + Venetoclax in people with Relapsed or Refractory Acute Myeloid Leukemia (AML), run by AstraZeneca at 10 sites in United States.
Trial summary
This study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies Part 1 of the study is monotherapy dose… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Relapsed or Refractory Acute Myeloid Leukemia (AML)
- What is being tested?
- AZD5991 and AZD5991 + Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Aug 2017to 8 Oct 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
- Men and women 18 to 85 years of age, inclusive.
- Diagnosis of AML and histologically proven based on criteria established by the World Health Organisation (WHO) as documented by medical records. Must have a measurable blast infiltration in bone marrow which will serve as a response parameter
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Must have received at least 1 prior line of therapy and there must be no treatment options available known to provide clinical benefit. Refer to National Comprehensive Cancer Network (NCCN) guidelines.
- Documented active disease requiring treatment per respective NCCN guideline that is relapsed or refractory defined as:
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- Recurrence of disease after response to prior line(s) of therapy.
- Or progressive disease after completion of the treatment regimen preceding entry into the study.
- WBC ≤10,000 cells/mm3 (10 x 109/L); use of leukapheresis or hydroxyurea before study drug initiation is allowed to achieve this entry criterion.
- Adequate hepatic and renal function at screening defined as:
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN).
- Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).
- Serum creatinine ≤1.5 times ULN and creatinine clearance ≥50 mL/min (measured or calculated by Cockcroft and Gault equation [(140-Age) • Mass (kg)/(72 • creatinine mg/dL) • multiply by 0.85 if female]).
- Lipase ≤1.5 x ULN and serum amylase ≤1.5 x ULN and no history of pancreatitis.
- Women should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test before start of dosing if of child-bearing potential or must have evidence of nonchildbearing potential.
- Men should be willing to use barrier contraception (ie, condoms) and refrain from sperm donation during and after the conduct of the trial.
Who cannot join
- Treatment with any of the following:
- Any investigational agents from a previous clinical study within 4 half-lives or 14 days, whichever is the greater, of said prior investigational agent(s) with regard to the first dose of study treatment on this protocol. Washout period not required in subjects with aggressive disease who require treatment sooner.
- Any other chemotherapy, immunotherapy or anticancer agents within 2 weeks of the first dose of study treatment. Washout period not required in subjects with aggressive disease who require treatment sooner.
- Any hematopoietic growth factors (eg, filgrastim [granulocyte colony-stimulating factor; G-CSF], sargramostin [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within 7 days of the first dose of study drug or pegylated G-CSF (pegfilgrastim) or darbepoetin within 14 days of the first dose of study drug.
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
- Except for alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.
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- AML with known active central nervous system involvement.
- As judged by the Investigator, any evidence of severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension, history of, or active, bleeding diatheses (eg, hemophilia or von Willebrand disease) or uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug.
- Malabsorption syndrome or other condition that precludes enteral route of administration.
- Chronic respiratory disease that requires continuous oxygen use.
- Known diagnosis of a hypercoagulable disorder other than malignancy
- Undergone any of the following procedures or experienced any of the following conditions currently or in the preceding 6 months:
- angina pectoris
- supraventricular arrhythmias, including atrial fibrillation, which are uncontrolled
- Myocarditis
- heart failure NYHA Class I or above
- Experienced any of the following conditions currently or at any previous timepoint
- Myocardial infarction (MI)
- coronary artery bypass graft
- angioplasty
- vascular stent
- Heart failure NYHA Class ≥ 2
- Ventricular arrhythmias requiring continuous therapy
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTcF) ≥ 450 msec applicable to both genders obtained from 3 electrocardiograms (ECGs) (averaged)
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, second to third degree AV block, sinus node dysfunction with clinically significant sinus pause
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age. Concomitant medications known to prolong QTc should be used with caution and cannot be used starting with the first dose of study drug and through the DLT review period.
- ST-wave depression and T-wave changes (e.g. inversion or flattened) in recent or screening ECG
- CPK assay reading ≥ ULN at screening
- Subjects with any troponin assay reading of ≥ULN during screening
- Left ventricular ejection fraction [LVEF] <55% with echocardiogram (ECHO) or multi-gated acquisition scan (MUGA). Appropriate correction to be used, if a MUGA is performed.
- History of severe allergic or anaphylactic reactions to BH3 mimetics or history of hypersensitivity to active or inactive excipients of AZD5991.
- Received the following within 7 days before initiation of venetoclax:
- Strong or moderate cytochrome P450 3A (CYP3A) inducers
- Strong or moderate CYP3A inhibitors
- Pg-P inhibitors
- Consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit within 3 days before the initiation of venetoclax.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Aurora, Colorado, 80045
Research Site
Boston, Massachusetts, 02215
Research Site
Columbus, Ohio, 43210
Research Site
Houston, Texas, 77030
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10065
Research Site
Orange, California, 92868
Research Site
Portland, Oregon, 97239
Research Site
St Louis, Missouri, 63110
About this study
Official title: A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination With Venetoclax in Subjects With Relapsed or Refractory Haematologic Malignancies
This study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies Part 1 of the study is monotherapy dose escalation. Closed November 2020 Part 2 of the study is monotherapy expansion groups for relapsed/refractory chronic lymphocytic leukaemia (CLL), AML/ myelodysplastic syndromes (MDS), and multiple myeloma (MM). Closed November 2020 Part 3 is a sequential, dose-escalation study of the combination of AZD5991 and venetoclax in subjects with relapsed/refractory AML
- Being tested
- AZD5991, AZD5991 + Venetoclax
- Keywords
- relapsed, refractory, AZD5991, Acute Myeloid Leukemia (AML)
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5991Drug
AZD5991 will be administered intravenously for 9 cycles (each cycle 21 days) or until patient derives treatment benefit or progresses
AZD5991 + VenetoclaxDrug
Ascending oral doses of AZD5991 and/or venetoclax until no longer tolerated or disease progression
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy AZD5991 | Experimental | Dose escalation - multiple dose levels Receives: Drug: AZD5991 |
| Monotherapy AZD5991 expansion | Experimental | Dose expansion Receives: Drug: AZD5991 |
| AZD5991 + venetoclax | Experimental | Dose escalation - multiple dose levels Receives: Drug: AZD5991 + Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
Measured: At every treatment and follow up visit until disease progression. Expected to be for up to 12 months
Dose limiting toxicities
Measured: Minimum observation period is 28 days per cohort
maximum tolerated dose
Measured: Minimum observation period is 28 days for the maximum dose cohort
Secondary outcomes (6)
Maximum observed plasma concentration of AZD5991 monotherapy and AZD5991+venetoclax
To assess the pharmacokinetics of AZD5991 monotherapy and AZD5991+venetoclax
Measured: Predose and through 24 hours postdose
Area under the concentration-time curve for plasma concentrations of AZD5991 monotherapy and AZD5991+venetoclax
To assess the pharmacokinetics of AZD5991 monotherapy and AZD5991+venetoclax
Measured: Predose and through 24 hours postdose
Objective response rate (ORR)
To assess the antitumor activity of AZD5991 monotherapy and AZD5991+venetoclax. Response will be evaluated every 8-12 weeks during treatment until progression.
Measured: From time of first dose until discontinuation of AZD5991 monotherapy and AZD5991+venetoclax expected to be for up to 12 months
Duration of response (DOR)
To assess the antitumor activity of AZD5991 monotherapy and AZD5991+venetoclax. Response will be evaluated every 8-12 weeks during treatment until progression.
Measured: From time of first dose until discontinuation of AZD5991 monotherapy and AZD5991+venetoclax expected to be for up to 12 months
Progression-free survival (PFS)
To assess the antitumor activity of AZD5991 monotherapy and AZD5991+venetoclax. Response will be evaluated every 8-12 weeks during treatment until progression.
Measured: From time of first dose until first observation of progression expected to be for up to 12 months
Complete remission rate (CRR)
To assess the antitumor activity of AZD5991 monotherapy and AZD5991+venetoclax. Response will be evaluated every 8-12 weeks during treatment until progression.
Measured: From time of first dose until discontinuation of AZD5991 monotherapy and AZD5991+venetoclax expected to be for up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start2 Aug 2017
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Model description
- This study is a 3 part, multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability,pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 alone or in combination with venetoclax in subjects with relapsed or refractory hematologic malignancies.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218683
- Sponsor's protocol ID
- D6910C00001
- Status last verified
- Sep 2022
- First submitted
- 6 Jul 2017
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
White MJ, Cheatham L, Wen S, Scarfe G, Cidado J, Reimer C, Hariparsad N, Jones RDO, Drew L, McGinnity DF, Vasalou C. A PKPD Case Study: Achieving Clinically Relevant Exposures of AZD5991 in Oncology Mouse Models. AAPS J. 2023 Jun 28;25(4):66. doi: 10.1208/s12248-023-00836-z.
PubMed 37380821Tron AE, Belmonte MA, Adam A, Aquila BM, Boise LH, Chiarparin E, Cidado J, Embrey KJ, Gangl E, Gibbons FD, Gregory GP, Hargreaves D, Hendricks JA, Johannes JW, Johnstone RW, Kazmirski SL, Kettle JG, Lamb ML, Matulis SM, Nooka AK, Packer MJ, Peng B, Rawlins PB, Robbins DW, Schuller AG, Su N, Yang W, Ye Q, Zheng X, Secrist JP, Clark EA, Wilson DM, Fawell SE, Hird AW. Discovery of Mcl-1-specific inhibitor AZD5991 and preclinical activity in multiple myeloma and acute myeloid leukemia. Nat Commun. 2018 Dec 17;9(1):5341. doi: 10.1038/s41467-018-07551-w.
PubMed 30559424
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination With Venetoclax in Subjects With Relapsed or Refractory Haematologic Malignancies
- ClinicalTrials.gov ID
- NCT03218683
- Acronym / sponsor ID
- D6910C00001
- Keywords
- relapsed, refractory, AZD5991, Acute Myeloid Leukemia (AML)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 14 Jul 2017 (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 study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies Part 1 of the study is monotherapy dose escalation. Closed November 2020 Part 2 of the study is monotherapy expansion groups for relapsed/refractory chronic lymphocytic leukaemia (CLL), AML/ myelodysplastic syndromes (MDS), and multiple myeloma (MM). Closed November 2020 Part 3 is a sequential, dose-escalation study of the combination of AZD5991 and venetoclax in subjects with relapsed/refractory AML
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a 3 part, multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability,pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 alone or in combination with venetoclax in subjects with relapsed or refractory hematologic malignancies.
| Arm | Type | Receives |
|---|---|---|
| Monotherapy AZD5991 | Experimental | Drug: AZD5991Dose escalation - multiple dose levels |
| Monotherapy AZD5991 expansion | Experimental | Drug: AZD5991Dose expansion |
| AZD5991 + venetoclax | Experimental | Drug: AZD5991 + VenetoclaxDose escalation - multiple dose levels |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
- Men and women 18 to 85 years of age, inclusive.
- Diagnosis of AML and histologically proven based on criteria established by the World Health Organisation (WHO) as documented by medical records. Must have a measurable blast infiltration in bone marrow which will serve as a response parameter
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Must have received at least 1 prior line of therapy and there must be no treatment options available known to provide clinical benefit. Refer to National Comprehensive Cancer Network (NCCN) guidelines.
Key exclusion criteria (37 listed)
- Treatment with any of the following:
- Except for alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.
- AML with known active central nervous system involvement.
- As judged by the Investigator, any evidence of severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension, history of, or active, bleeding diatheses (eg, hemophilia or von Willebrand disease) or uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug.
- Malabsorption syndrome or other condition that precludes enteral route of administration.
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 |
|---|---|---|
| AZD5991AZD5991 will be administered intravenously for 9 cycles (each cycle 21 days) or until patient derives treatment benefit or progresses | Drug | Monotherapy AZD5991, Monotherapy AZD5991 expansion |
| AZD5991 + VenetoclaxAscending oral doses of AZD5991 and/or venetoclax until no longer tolerated or disease progression | Drug | AZD5991 + venetoclax |
Primary outcome
Incidence of Adverse Events
Time frame: At every treatment and follow up visit until disease progression. Expected to be for up to 12 months
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
Dose limiting toxicities
Time frame: Minimum observation period is 28 days per cohort
maximum tolerated dose
Time frame: Minimum observation period is 28 days for the maximum dose cohort
6 secondary outcomes
Maximum observed plasma concentration of AZD5991 monotherapy and AZD5991+venetoclax
Time frame: Predose and through 24 hours postdose
Area under the concentration-time curve for plasma concentrations of AZD5991 monotherapy and AZD5991+venetoclax
Time frame: Predose and through 24 hours postdose
Objective response rate (ORR)
Time frame: From time of first dose until discontinuation of AZD5991 monotherapy and AZD5991+venetoclax expected to be for up to 12 months
Duration of response (DOR)
Time frame: From time of first dose until discontinuation of AZD5991 monotherapy and AZD5991+venetoclax expected to be for up to 12 months
Progression-free survival (PFS)
Time frame: From time of first dose until first observation of progression expected to be for up to 12 months
Complete remission rate (CRR)
Time frame: From time of first dose until discontinuation of AZD5991 monotherapy and AZD5991+venetoclax expected to be for up to 12 months
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Derived from this study: PubMed 37380821White MJ, Cheatham L, Wen S, Scarfe G, Cidado J, Reimer C, Hariparsad N, Jones RDO, Drew L, McGinnity DF, Vasalou C. A PKPD Case Study: Achieving Clinically Relevant Exposures of AZD5991 in Oncology Mouse Models. AAPS J. 2023 Jun 28;25(4):66. doi: 10.1208/s12248-023-00836-z.
- Derived from this study: PubMed 30559424Tron AE, Belmonte MA, Adam A, Aquila BM, Boise LH, Chiarparin E, Cidado J, Embrey KJ, Gangl E, Gibbons FD, Gregory GP, Hargreaves D, Hendricks JA, Johannes JW, Johnstone RW, Kazmirski SL, Kettle JG, Lamb ML, Matulis SM, Nooka AK, Packer MJ, Peng B, Rawlins PB, Robbins DW, Schuller AG, Su N, Yang W, Ye Q, Zheng X, Secrist JP, Clark EA, Wilson DM, Fawell SE, Hird AW. Discovery of Mcl-1-specific inhibitor AZD5991 and preclinical activity in multiple myeloma and acute myeloid leukemia. Nat Commun. 2018 Dec 17;9(1):5341. doi: 10.1038/s41467-018-07551-w.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 AZD5991 and AZD5991 + Venetoclax in people with Relapsed or Refractory Acute Myeloid Leukemia (AML), run by AstraZeneca at 10 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 16 inclusion and 37 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: stopped early, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
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?
Incidence of Adverse Events (time frame: At every treatment and follow up visit until disease progression. Expected to be for up to 12 months). 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 NCT03218683, which also lists 2 linked publications.
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 23 Sep 2022.