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Acute LeukemiaPhase 1/2NCT03176277

A Study of ONO-7475 in Patients With Acute Leukemias

A Phase 1/2 study testing ONO-7475 3mg once daily, ONO-7475 6mg once daily and ONO-7475 10mg once daily in people with Acute Leukemia and Myelodysplastic Syndromes, run by Ono Pharmaceutical Co., Ltd. at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

[Updated]: To assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes and to assess: i) safety and tolerability and ii) preliminary efficacy of the combination of ONO-7475 and venetoclax in patients… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Leukemia, Myelodysplastic Syndromes
What is being tested?
ONO-7475 3mg once daily, ONO-7475 6mg once daily and ONO-7475 10mg once daily
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
16 sitesUnited States
Study dates
26 Jun 2017to 20 Jan 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients aged ≥18 years at time of screening.
  • Written informed consent by the patient (or their legal representative) prior to admission to this study. In addition, any locally required authorization (Health Insurance Portability and Accountability Act in the US), must be obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
  • Adequate renal and hepatic function defined as:
  • Total bilirubin within 1.5 x upper limit of normal (ULN), except those with Gilberts syndrome for whom this must be ≤3 x ULN
  • AST and ALT ≤2.5 x ULN
  • Calculated creatinine clearance ≥45 mL/min
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  • Serum albumin ≥2.5 g/dL For any patient with laboratory values outside the ranges outlined above that are considered due to the patient's underlying disease (AML or MDS), the patient may be enrolled into the study following consultation between the Investigator and the Sponsor's Medical Officer, if the patient is likely to benefit from receiving ONO-7475 (based on the Investigator's assessment).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 as assessed during the screening period and then again anytime during the 2-day period immediately preceding the start of dosing in Parts A and D.
  • Life expectancy of at least 3 months
  • Sexually active female patients of childbearing potential and sexually active male patients must agree to use an effective method of birth control (e.g., barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 4 months after final administration of study drug. Note that sterility in female patients must be confirmed in the patients' medical records and be defined as any of the following: surgical hysterectomy with bilateral oophorectomy, bilateral tubular ligation, natural menopause with last menses >1 year ago, radiation-induced oophorectomy with last menses >1 year ago, chemotherapy-induced menopause with last menses >1 year ago.
  • Diagnosis of AML or MDS according to WHO criteria 2016 (Part A only).
  • Either criterion is met (Part A only):
  • Patients with R/R AML with at least 5% blasts by BM biopsy or aspirate, or at least 1% blasts in peripheral blood, not likely to benefit from standard salvage chemotherapy
  • Patients with R/R MDS who are either not eligible for (or unlikely to benefit from) other forms of therapy, including HSCT, according to the treating Physician/Investigator .
  • All patients must have received at least one previous line of therapy (Part A only).
  • Diagnosis of AML according to WHO criteria (2016) (Part D only).
  • Patients with R/R AML who have no standard-of-care options known to provide clinical benefit in patients with R/R AML (Part D only)
  • Refractory AML: Patients who have not achieved complete remission after two cycles of induction chemotherapy (i.e., anthracycline containing regimen), four cycles of hypomethylating agents, or two cycles of other AML therapy
  • Relapsed AML: Patients who have ≥5% BM blasts in BM, or reappearance of blasts in the peripheral blood not attributable to another cause (e.g., recovery of normal cells following chemotherapy-induced aplasia) or (re)appearance of extramedullary disease after CR of prior AML therapy.
  • Patients must have measured BM aspirate blast counts at Screening. Where the aspirate is hypo cellular or inaspirable a biopsy would be considered.
  • Patients who were refractory to or relapsed after their 1st line treatment for AML must have received 2 or less additional lines of intensive / aggressive chemotherapy, which also includes a venetoclax-based regimen, as per the latest National Comprehensive Cancer Network (NCCN) Guidelines.

Who cannot join

  • Patients with active central nervous system leukemia.
  • QT interval corrected according to Fredericia's formula (QTcF) prolongation defined as a QTcF interval >470 msec or other significant ECG abnormalities including second degree (type II) or third degree atrioventricular block or bradycardia (ventricular rate <50 beats/min).
  • Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or severe cirrhosis.
  • Human immunodeficiency virus (HIV), active hepatitis B (HBV) or C (HCV) infection.
  • Retinal disease (e.g., retinitis pigmentosa including Mertk mutations), retinal hemorrhage or any disorder which may inhibit follow up for retinal toxicity.
  • Serious intercurrent medical or psychiatric illness that will prevent participation or compliance with study procedures, including serious active infection (including COVID-19).
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  • Acute promyelocytic leukemia (the French-American-British M3 classification).
  • Patients not recovered to Grade 1 or stabilized from the effects (excluding alopecia) of any prior therapy for their malignancies.
  • Concurrent treatment with other investigational drugs.
  • Daily requirement of ≥10 mg/day of prednisone or equivalent dose of other corticosteroids.
  • Prior HSCT within 12 weeks of the first dose of study treatment or ongoing immunosuppressive therapy for graft-versus-host disease.
  • Participation in another clinical trial with any investigational drug within 14 days or with any licensed drug within five half-lives, prior to the first ONO-7475 dosing (for Part A) or prior to the first venetoclax dosing (for Part D).
  • Prior AML or MDS therapy (non-experimental) within 14 days or 5 half-lives, whichever is longer, prior to the first dose of ONO-7475 (for Part A) or prior to the first venetoclax dosing (for Part D) (except those permitted in Section 7.1) and no residual toxicity from the prior therapy hindering of the ONO-7475 dosing (for Part A) or ONO-7475 plus venetoclax dosing (for Part D).
  • Prior radiotherapy within 21 days of screening, with the exception of localized palliative radiotherapy.
  • Patients undergoing current treatments for other cancers.
  • Pregnant or lactating women.
  • Proliferative disease (white blood cell [WBC] counts >30 x 10e9/L) confirmed prior to the first dose of ONO-7475 (for Part A) or WBC >25 x 10e9/L in Part D.
  • Active malignancy, other than AML (Parts A and D) or MDS (Part A), requiring systemic therapy except for those patients who have been diagnosed with either prostate or breast cancer and who have received a stable dose of hormone therapy for a minimum of 6 months prior to entering this study.
  • Known hypersensitivity to venetoclax (Part D only).
  • Calculated creatinine clearance <45 mL/min

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • The Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Medical University of South Carolina - Hollins Cancer Center

    Charleston, South Carolina, 29425

  • The Ohio State University (OSU)

    Columbus, Ohio, 43210

  • University of Florida (UF) - Shands Cancer Center

    Gainesville, Florida, 32610

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • University of Southern California

    Los Angeles, California, 90033

  • University of California

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Yale University School of Medicine - Yale Cancer Center

    North Haven, Connecticut, 06510

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase I/II Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Efficacy of ONO-7475 in Patients With Acute Leukemias or Myelodysplastic Syndromes

[Updated]: To assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes and to assess: i) safety and tolerability and ii) preliminary efficacy of the combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute myeloid leukemia.

Read the detailed description

Part A is a dose escalation study of ONO-7475 in patients with acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes.

Part D is a dose escalation study of ONO-7475 in combination with venetoclax. ONO-7475 starting dose is selected following safety and tolerability outcome of Part A.

Being tested
ONO-7475 3mg once daily, ONO-7475 6mg once daily, ONO-7475 10mg once daily, ONO-7475 6mg + Venetoclax (70-400mg)
Keywords
Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, MER, MERTK, TYRO3, AXL, AML, Relapsed/ Refractory AML, TAM, MDS, Myelodysplastic Syndrome, Relapsed/ Refractory MDS
Medical subject headings
Myelodysplastic Syndromes, Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONO-7475 3mg once dailyDrug

    Also called Part A initial dose level

    Part A initial dose level

  • ONO-7475 6mg once dailyDrug

    Also called Part A 2nd dose level

    Part A 2nd dose level

  • ONO-7475 10mg once dailyDrug

    Also called Part A 3rd dose level

    Part A 3rd dose level

  • ONO-7475 6mg + Venetoclax (70-400mg)Drug

    Also called ONO-7475 + Venetoclax Combination

    Part D ONO-7475 + Venetoclax Combination

Study groups in NCT03176277
Study groupRoleWhat they receive
ONO-7475 3mg once dailyExperimentalPart A Initial dose level
Receives: Drug: ONO-7475 3mg once daily
ONO-7475 6mg once dailyExperimentalPart A 2nd dose level
Receives: Drug: ONO-7475 6mg once daily
ONO-7475 10mg once dailyExperimentalPart A 3rd dose level
Receives: Drug: ONO-7475 10mg once daily
ONO-7475 6mg + Venetoclax (70-400mg)ExperimentalPart D ONO-7475 + Venetoclax combination
Receives: Drug: ONO-7475 6mg + Venetoclax (70-400mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (Part A)

    Incidence of most common (frequency of >20%) treatment-emergent adverse events (TEAEs) of CTCAE grade 3 or higher by preferred terms coded with MedDRA version 23.1.

    CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

    Measured: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).

  2. Incidence of Serious Adverse Events (Part A)

    Incidence (frequency ≥ 2 participants) of serious treatment-emergent adverse events (all CTCAE grades) by preferred terms coded with MedDRA version 23.1.

    CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

    Measured: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).

  3. Clinically Significant Changes in Ophthalmology Examination Parameters (Part A)

    Incidence (all participants) of ophthalmological treatment-emergent adverse events (all CTCAE grades) by preferred terms coded with MedDRA Version 23.1.

    CTCAE = Common Terminology Criteria for Adverse Event version 4.03.

    Measured: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).

  4. Clinically Significant Changes in 12-Lead Electrocardiogram Parameters (Part A)

    Participants with clinically significant changes in 12-lead Electrocardiogram (ECG) parameters.

    Measured: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).

  5. Incidence of Adverse Events (Part D)

    Incidence of most common (frequency > 20%) treatment-emergent adverse events (TEAEs) of CTCAE grade 3 or higher by preferred term coded with MedDRA version 23.1.

    CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

    Measured: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 21 months).

  6. Incidence of Serious Adverse Events (Part D)

    Incidence (frequency ≥ 2 participants) of serious treatment-emergent adverse events (all CTCAE grades) by preferred terms coded with MedDRA version 23.1.

    CTCAE = Common Terminology Criteria for Adverse Events (CTXAE) Version 4.03.

    Measured: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 21 months).

  7. Complete Response (CR) / Complete Response With Partial Hematologic Recovery (CRh) Rate (Part D)

    Summary of complete response (CR) and complete response with partial hematologic recovery (CRh) rate.

    Measured: From baseline up to maximum of 21 months

Secondary outcomes (23)

  1. Determination of Maximum Tolerated Dose (MTD) by Assessing Dose Limiting Toxicities (DLT) (Part A)

    Dose Limiting Toxicities (DLT) Criteria: 1) ONO-7475-related ≥Grade 4 hematologic toxicity, 2) any pre-existing condition that worsens by more than 1 grade or to Grade 4, not caused by AML, 3) any ≥Grade 3 non-hematologic toxicity not caused by AML (exception: alopecia, nausea, vomiting, fatigue, headache, chills, electrolyte disturbances), 4) ≥Grade 2 blurred vision (confirmed by loss of 15 letters or more on Early Treatment Diabetic Retinopathy chart and by ophthalmological and retinal assessments) not caused by AML, 5) ≥Grade 2 clinically significant changes in night blindness not caused by AML, 6) ≥Grade 3 differentiation syndrome, 7) death not caused by AML, and 8) any other event determined by the Safety Review Committee for dosing stop.

    Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 was applied for toxicity grading.

    Measured: 28 days

  2. Pharmacokinetics (Cmax and Ctrough) of ONO-7475 (Part A)

    Part A Pharmacokinetics Cmax of ONO-7475 assessed on day 1 and day 28, and Ctrough of ONO-7475 assessed on day 28 (pre-dose).

    Measured: Day 1 and Day 28

  3. Pharmacokinetics (Tmax) of ONO-7475 (Part A)

    Part A Pharmacokinetics Tmax of ONO-7475 assessed on day 1 and day 28.

    Measured: Day 1 and Day 28

  4. Pharmacokinetics (AUC) of ONO-7475 (Part A)

    Part A Pharmacokinetics (AUC0-10h) of ONO-7475 assessed on day 1 and day 28, (AUC0-24h) of ONO-7475 assessed on day 1.

    Measured: Day 1 and Day 28

  5. Pharmacokinetics (T1/2) of ONO-7475 (Part A)

    Part A Pharmacokinetics T1/2 of ONO-7475 assessed on day 1 and day 28. T1/2 was not calculable due to insufficient evaluable data.

    Measured: Day 1 and Day 28

  6. Pharmacokinetics of the Food Effect on ONO-7475 (Part A)

    Part A Pharmacokinetics (Cmax, Tmax, AUC, T1/2, Ctrough) of the food effect on ONO-7475 assessed as ratio of Day57/Day28 and comparing pharmacokinetic parameters from dosing under fasted and non-fasted conditions assessed in 6mg and 10mg dose groups.

    Measured: Day 28 and Day 57

  7. Pharmacodynamics (Axl and Mer Inhibition) of ONO-7475 (Part A)

    Assessment of the pharmacodynamic activity by measurement of Axl and Mer inhibition using a Plasma Inhibitory Activity (PIA) assay. PIA is a flow cytometry assay measuring auto-phosphorylation in Axl-expressing Ba/F3 and Mer-expressing Ba/F3 cells, respectively the percentage of inhibition. Pre-dose samples were collected for the analysis on day 2 and day 28.

    Measured: Day 2 and Day 28

  8. Overall Response Rate and Duration of Response in ONO-7475 Groups (Part A)

    Part A analysis of best overall response. Duration of response analysis was not performed as no response of complete remission, Morphologic complete remission with incomplete blood count recovery, morphologic leukemia-free state, or partial remission was observed.

    Measured: From baseline up to maximum of 32 months

  9. Event Free Survival in ONO-7475 Groups (Part A)

    Part A analysis of event free survival in ONO-7475 treatment groups

    Measured: From baseline up to maximum of 32 months

  10. Pharmacokinetics (Cmax) of ONO-7475 in Treatment Group ONO-7475 + Venetoclax (Part D)

    Part D Pharmacokinetics (Cmax) of ONO-7475 in treatment group ONO-7475 + venetoclax.

    Measured: Day 29

  11. Pharmacokinetics (Tmax) of ONO-7475 in Treatment Group ONO-7475 + Venetoclax (Part D)

    Part D Pharmacokinetics (Tmax) of ONO-7475 in treatment group ONO-7475 + venetoclax.

    Measured: Day 29

  12. Pharmacokinetics (AUC) of ONO-7475 in Treatment Group ONO-7475 + Venetoclax (Part D)

    Part D Pharmacokinetics (AUC) of ONO-7475 in treatment group ONO-7475 + venetoclax.

    Measured: Day 29

  13. Pharmacokinetics (T1/2) of ONO-7475 in Treatment Group ONO-7475 + Venetoclax (Part D)

    Part D Pharmacokinetics (T1/2) of ONO-7475 in treatment group ONO-7475 + venetoclax.

    Measured: Day 29

  14. Pharmacokinetics (Cmax) of Venetoclax in Treatment Group ONO-7475 + Venetoclax (Part D)

    Part D Pharmacokinetics (Cmax) of Venetoclax in treatment group ONO-7475 + Venetoclax.

    Measured: Day 1 and Day 29

  15. Pharmacokinetics (Tmax) of Venetoclax in Treatment Group ONO-7475 + Venetoclax (Part D)

    Part D Pharmacokinetics (Tmax) of Venetoclax in treatment group ONO-7475 + venetoclax.

    Measured: Day 1 and Day 29

  16. Pharmacokinetics (AUC) of Venetoclax in Treatment Group ONO-7475 + Venetoclax

    Part D Pharmacokinetics (AUC) of Venetoclax in treatment group ONO-7475 + venetoclax.

    Measured: Day 1 and Day 29

  17. Pharmacokinetics (T1/2) of Venetoclax in Treatment Group ONO-7475 + Venetoclax (Part D)

    Part D Pharmacokinetics (T1/2) of Venetoclax in treatment group ONO-7475 + venetoclax.

    Measured: Day 29

  18. Incidence of Adverse Events in ONO-7475 + Venetoclax Group (Part D)

    Part D Incidence (frequency > 20%) and severity (CTCAE grades) of treatment-emergent adverse events in ONO-7475 + Venetoclax Group, in preferred terms coded MedDRA version 23.1.

    CTCAE = common terminology criteria for adverse events (CTCAE) version 4.03.

    Measured: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 21 months).

  19. Incidence of Serious Adverse Events in ONO-7475 + Venetoclax Group (Part D)

    Part D Incidence (frequency ≥ 2 participants) and severity (CTCAE grades) of serious treatment-emergent adverse events in ONO-7475 + Venetoclax Group (Part D), preferred term coded with MedDRA version 23.1.

    CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

    Measured: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 21 months).

  20. Overall Response Rate in ONO-7475 + Venetoclax Group (Part D)

    Part D Summary of best overall response in ONO-7475 + Venetoclax group.

    Measured: From baseline up to maximum of 21 months

  21. Duration of Response in ONO-7475 + Venetoclax Group (Part D)

    Part D Duration of response in ONO-7475 6mg + Venetoclax group.

    Measured: From baseline up to maximum of 21 months

  22. Event-Free Survival and Overall Survival in ONO-7475 + Venetoclax Group (Part D)

    Part D analysis of event free survival and overall survival in ONO-7475 6mg + Venetoclax group

    Measured: From baseline up to maximum of 21 months

  23. Transfusion Independence Rate (Part D)

    Part D analysis of transfusion Independence rate. Rate of maintenance of transfusion independence = percentage of patients who were transfusion independent post-baseline based upon the patients who were transfusion independent at baseline.

    Calculated using the Clopper-Pearson method.

    Measured: From baseline up to maximum of 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start26 Jun 2017
  3. Primary completion1 Dec 2022
  4. Study completion20 Jan 2023

Why it stopped: Protocol defined futility criteria

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Part A: ONO-7475 open-label, dose escalation in R/R AML or R/R MDS Part D: ONO-7475 plus venetoclax open-label, dose escalation in R/R AML
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03176277
Sponsor's protocol ID
ONO-7475-01
Status last verified
Jul 2024
First submitted
19 May 2017
Last updated
15 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kasner MT, Courtenay-Luck N, DiNardo C, Post SM, Baratam P, Magrath GN, Nakamura T, Fujii A, Prados S, Honda N, Mcbride M, Edwards-Holmes P, Stuart R. Anexelekto (Axl)/Mer Inhibitor Tamnorzatinib in Patients with Relapsed/Refractory Acute Myeloid Leukaemia: Results from a Phase I (Monotherapy) and Phase II (Combination with Venetoclax) Clinical Study. Acta Haematol. 2025 Dec 12:1-11. doi: 10.1159/000549340. Online ahead of print.

    PubMed 41385448

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ONO-7475 3mg once daily, ONO-7475 6mg once daily and ONO-7475 10mg once daily in people with Acute Leukemia and Myelodysplastic Syndromes, run by Ono Pharmaceutical Co., Ltd. at 16 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 21 inclusion and 20 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 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (Part A) (time frame: From start of study drug up to 30 days after permanent discontinuation of study drug or initiation of new anti-cancer therapy, whichever occurs first (maximum of 32 months).). 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?

On the ClinicalTrials.gov record for NCT03176277, 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 15 Jul 2024.

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