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Neuroendocrine TumorsPhase 1/2NCT02592707

Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs

A Phase 1/2 study testing Satoreotide tetraxetan, Amino acid solution and Antiemetic in people with Neuroendocrine Tumors, run by Ipsen at 9 sites in 8 countries.

Terminated

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

Official record
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Trial summary

The purpose of this clinical phase I/II study was to investigate the safety and tolerability of satoreotide tetraxetan (177Lu-IPN01072, formerly known as 177Lu-OPS201) used for the treatment of patients with neuroendocrine tumors (NETs). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
Satoreotide tetraxetan, Amino acid solution and Antiemetic
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
9 sitesin 8 countries
Study dates
6 Mar 2017to 22 Feb 2022
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

  • Written informed consent.
  • Patients of either gender, aged ≥ 18 years.
  • Women of childbearing potential (not surgically sterile or less than 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 6 months after the last dose. Acceptable methods of contraception include abstinence, or double contraception: steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method (intrauterine device, condom etc.).
  • Male patients must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 6 months after the last activity administration.
  • Karnofsky performance score ≥ 60.
  • Life expectancy of at least 6 months.
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  • Histologically confirmed diagnosis of -
  • unresectable GEP NET (Grade I and Grade II according to WHO classification (2010, Annex 01), functioning and non-functioning).
  • unresectable "typical lung carcinoid" or "atypical lung carcinoid" are acceptable (with the exception of Large Cell Bronchial Neuroendocrine Neoplasms and Small Cell Lung Cancers) (Caplin 2015).
  • malignant, unresectable pheochromocytoma or paraganglioma
  • Documentation of progressive disease based on RECIST v1.1 under prior anti-tumor therapy within 6 months of entry in the study (although the progression might have occurred more than 6 months before study entry). Patients should not have received further anti-tumor therapy once disease progression is documented. The images of this evaluation should be available for TGR evaluation.
  • In countries where sunitinib or everolimus are marketed, patients with GEP NET and lung NET will be progressive under this prior anti-tumor treatment for the respective indication. Patients not suitable for everolimus/sunitinib therapy according to a tumor board decision (or comparable local practice) may also be enrolled into the study. Patients having everolimus/sunitinib therapy should have a wash-out phase of ≥ 4 weeks before the first treatment.
  • Measurable disease based on RECIST v1.1.
  • Confirmed presence of somatostatin receptors on technically evaluable tumor lesions documented by a positive Somatostatin Receptor Scan performed within 6 months prior to enrolment in the study.
  • Calculated GFR ≥ 55 mL/min.
  • Blood test results as follows:
  • Leukocytes: ≥ 4*10^9/L
  • Erythrocytes: ≥ 3.5*12^9/L
  • Platelets: ≥ 100*10^9/L
  • Albumin: > 30 g/L
  • ALT, AST, AP: ≤ 5 times ULN (upper limit of normal)
  • Bilirubin: ≤ 2 times ULN (2x 1.1 mg/dL)

Who cannot join

  • Known hypersensitivity to 177Lu, to DOTA, to JR11 or to any of the excipients of 177Lu-OPS201.
  • Any previous peptide receptor radionuclide therapy (PRRT).
  • Diagnosis of thymic NET.
  • Presence of active infection at screening or history of serious infection within the previous 6 weeks.
  • Administration of any other investigational medicinal product within 60 days prior to entry.
  • Prior or planned administration of a therapeutic radiopharmaceutical within 8 half-lives of the radionuclide including any time during the current study.
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  • Any extensive radiotherapy ≤ 3 months before enrolment.
  • Chemotherapy ≤ 3 months before enrolment.
  • Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject at high risk of renal toxicity during the study as assessed by the investigator.
  • Pregnant or breast-feeding women: A pregnancy test will be performed at the start of the study for all female patients of childbearing potential (i.e. not surgically sterile or up to 2 years postmenopausal).
  • Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus [HbA1c ≥9%], uncontrolled congestive heart disease, etc.) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Note: the patient should be able to tolerate high volume load.
  • Current history of any malignancy other than NET within 5 years of enrolment except for fully -resected non-melanoma skin cancer or cervical cancer in situ. Current history of malignancy; patients with a secondary tumor in remission of > 5 years can be included
  • Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.

Trial locations and contacts

9 sites in 8 countries.

9 sites in 8 countries

Australia2 sites

  • Peter MacCallum Cancer Centre, Molecular Imaging and Targeted Therapeutics Laboratory

    East Melbourne, 3002

  • Ramsay Hollywood Private Hospital, Department of Nuclear Medicine

    Perth, 6009

Other trials in Australia

United States1 site

  • MD Anderson Cancer Center, Department of Nuclear Medicine

    Houston, Texas, 77030

Other trials in United States

Austria1 site

  • University Hospital Vienna, Department of Nuclear Medicine

    Vienna, 1090

Other trials in Austria

Canada1 site

  • CHU de Quebec - Universite Laval Research Center, Department of Radiology and Nuclear Medicine

    Québec, G1R2J6

Other trials in Canada

Denmark1 site

  • University Hospital Aarhus, Department of Hepatology and Gastroenterology

    Aarhus, 8000

Other trials in Denmark

France1 site

  • CHU de Nantes, Hotel Dieu, Service de Medecine Nucleaire

    Nantes, 44093

Other trials in France

Switzerland1 site

  • University Hospital Basel, Department of Nuclear Medicine

    Basel, 4031

Other trials in Switzerland

United Kingdom1 site

  • Royal Free Hospital, Department of Nuclear Medicine

    London, NW3 2QG

Other trials in United Kingdom

About this study

Official title: An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

The purpose of this clinical phase I/II study was to investigate the safety and tolerability of satoreotide tetraxetan (177Lu-IPN01072, formerly known as 177Lu-OPS201) used for the treatment of patients with neuroendocrine tumors (NETs). The secondary objectives of this study were the assessment of biodistribution, dosimetry and preliminary efficacy of satoreotide tetraxetan.

Being tested
Satoreotide tetraxetan, Amino acid solution, Antiemetic
Medical subject headings
Neuroendocrine Tumors

What participants receive

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

  • Satoreotide tetraxetanDrug

    Also called 177Lu-OPS201, 177Lu-IPN01072

    Satoreotide tetraxetan administered in 3 cycles at intervals of 8 weeks (+ up to 2 additional optional cycles)

  • Amino acid solutionOther

    Also called OPS301, IPN60070, Arginine and lysine

    Given as an auxiliary product the day of the IMP infusion for safety reasons to protect the renal function.

    Centres can use their established amino acid infusion or Ipsen amino acid solution (auxiliary medical product OPS301)

  • AntiemeticOther

    Also called Dexamethasone, Ondansetron

    To counteract the known side effects of the amino acid infusion, such as nausea, dexamethasone (antiemetic) and as-required ondansetron will be administered 15 to 30 minutes before the start of the amino acid infusion (unless there are contraindications for these drugs).

Study groups in NCT02592707
Study groupRoleWhat they receive
177Lu-IPN01072Experimental177Lu-IPN01072 administered in 3 cycles at intervals of 8 weeks (+ up to 2 additional optional cycles)
Receives: Drug: Satoreotide tetraxetan; Other: Amino acid solution; Other: Antiemetic

What is being measured

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

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

    AE is defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product, which did not necessarily have a causal relationship with this treatment. A serious AE (SAE) was classified as any untoward medical occurrence that at any dose results in death; AE was life threatening; required inpatient hospitalization or prolonged existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was an important medical event that may not result in death. TEAEs are defined as AEs that developed or worsened after start of treatment.

    Measured: From the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, maximum of 33 months

  2. Number of Participants With Dose Limiting Toxicities (DLT)

    DLTs were defined as study medication-related AEs with a severity of Grade 3 or higher are considered DLT, with the exception of hair loss, lymphopenia, nonfebrile neutropenia lasting <4 weeks and thrombocytopenia lasting <4 weeks.

    Measured: From the start of the first study medication (Cycle 1 Day 1) up to EOCT, maximum of 16 weeks.

Secondary outcomes (23)

  1. Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1

    177Lu-IPN01072 uptake in organs and lesions was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Uptake activity for organs of interest (i.e., body, bone marrow, kidney [left + right], healthy liver, and spleen) was determined. The maximal uptake in lesions was calculated for each lesion as: maximal activity divided injected activity*100.

    Measured: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

  2. Maximal Uptake (%) of 177Lu-IPN01072 in Blood in Cycle 1

    177Lu-IPN01072 uptake in blood was evaluated on site/locally using a gamma counter calibrated for 177Lu-IPN01072 according to the dosimetry operational manual.

    Measured: Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

  3. Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1

    The AUC of 177Lu-IPN01072 radioactivity in discernible organs were computed for each administration of 177Lu-IPN01072.

    Measured: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

  4. AUC of 177Lu-IPN01072 in Blood in Cycle 1

    The AUC of 177Lu-IPN01072 radioactivity in blood were computed for each administration of 177Lu-IPN01072.

    Measured: Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

  5. Terminal Half-Life (T1/2) of Radioactivity Concentrations of the Radiopharmaceutical in Blood in Cycle 1

    The terminal half-life was defined as the largest half-life of the decay curve of blood activity.

    Measured: Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

  6. Highest Absorbed Dose of 177LU-IPN01072 to Each Discernible Organ in Cycle 1

    The absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. The organs considered for 177LU-IPN01072 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. Highest absorbed dose of 177Lu-IPN01072 was calculated as described in the Dosimetry calculation procedure manual. Maximum value observed for each discernible organs across participants has been reported.

    Measured: 4, 24, 48, 72 to 96 and 144 to 168 hours post infusion in Cycle 1

  7. Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1

    The specific absorbed dose was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Data are presented for all lesions, regardless of their anatomical localization. The organs considered for 177Lu-IPN01072 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. The specific absorbed dose to the lesions was the absorbed dose by the lesion (unit: Gray) divided by the injected radioactivity (unit: GBq) for each lesion selected for dosimetry evaluation. The specific absorbed dose for a given organ was the absorbed dose by this organ (unit: Gray) divided by the injected radioactivity (unit: GBq).

    Measured: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

  8. Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3

    The cumulative absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow.

    Measured: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycles 1 and 3

  9. Cumulative Amount of Lu-177 Radioactivity Excreted Into the Urine (0 to 48 Hours) [Ae (0-48h)] in Cycle 1

    Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 only.

    Measured: 0 to 6 hours, 6 to 24 hours, 24 to 48 hours post-infusion in Cycle 1 of Part A; 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 of Part B.

  10. Time to Reach Maximum Plasma Concentration (Tmax) of IPN01072 in Cycle 1

    The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.

    Measured: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

  11. Maximum Observed Plasma Concentration (Cmax) of IPN01072 in Cycle 1

    The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.

    Measured: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

  12. AUC From Time Zero to Infinity (AUCinf) of IPN01072 in Cycle 1

    The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.

    Measured: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

  13. T1/2 of IPN01072 in Cycle 1

    The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.

    Measured: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

  14. Apparent Total Plasma Clearance of IPN01072 (Total CL) in Cycle 1

    The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.

    Measured: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

  15. Apparent Volume of Distribution During Terminal Phase (Vz) of IPN01072 in Cycle 1

    The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.

    Measured: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

  16. Ae (0-48h) of IPN01072 in Cycle 1

    Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 for Part B only.

    Measured: 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 of Part B

  17. Fraction of IPN01072 Excreted Into the Urine (Fe) in Cycle 1

    Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 for Part B only.

    Measured: 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 in Part B

  18. Overall Response Rate (ORR)

    The ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) as best overall response (BOR) according centralized to response evaluation criteria in solid tumours (RECIST) version 1.1 from investigator assessment. Participants with no tumour assessment after the start of study treatment were not evaluated. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

  19. Disease Control Rate (DCR)

    The DCR was defined as the percentage of participants who achieved a CR, a PR or a stable disease (SD) as BOR according to Investigator assessment RECIST version 1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

    Measured: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

  20. Best Overall Response

    The BOR according to RECIST v1.1 was defined as the best response recorded from the initiation of treatment until the EOCT/end of additional cycles (EOAC)/early withdrawal (EW) Visit (during the core study part), prior to the Investigator assessment of PD. Progression was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm.

    Measured: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

  21. Progression Free Survival (PFS)

    The PFS was defined as the time from start of study treatment until occurrence of tumour progression or death, according to Investigator assessment RECIST version 1.1. Estimation of the median was based on the Kaplan-Meier method.

    Measured: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

  22. Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit

    The European Organisation for Research and Treatment of Cancer (EORTC) score questionnaire (QLQ-C30) was used for QoL evaluation. Each scale in the questionnaire were scored (0 to 100) according to the EORTC recommendations in the EORTC QLQ-C30 scoring manual. The scale included a global health status, where high score for the global health status represents a high QoL. The functional scales consisted of physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, where a higher value reflects a better level of function. Nine symptoms scales included nausea and vomiting, pain, fatigue, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties, where a higher value reflects worse symptoms. Baseline was defined as the last non-missing measurement collected prior to the first dose of study drug (Day 1).

    Measured: Baseline (Day 1) and EOCT visit (30 months)

  23. Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit

    The GI.NET21 module was intended for use among participants with gastrointestinal related (GI.- related) neuroendocrine tumours, who vary in disease stage and treatments. The module comprises 21 questions, consisting of 5 scales (endocrine symptoms, G.I. symptoms, treatment related symptom, social function, disease related worries) and 4 single items that assessed muscle /bone pain symptom, sexual function, information/communication function, and body image. Each question was quoted from 1 (not at all) to 4 (very much). Each scale in the questionnaire was scored from 0 to 100. A higher value was equivalent to worse or more problems. Baseline was defined as the last non-missing measurement collected prior to the first dose of study drug (Day 1).

    Measured: Baseline (Day 1) and EOCT visit (30 months)

Timeline

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

  1. First posted30 Oct 2015 (estimated)
  2. Study start6 Mar 2017
  3. Primary completion22 Feb 2022
  4. Study completion22 Feb 2022

Why it stopped: Terminated (Due to small number of ongoing patients. Patients ongoing at time of termination could choose to join study D-FR-01072-004 for long term follow-up.

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02592707
Sponsor's protocol ID
D-FR-01072-001
Other IDs
2015-002867-41, OPS-C-001, 2015
Status last verified
Jul 2023
First submitted
15 Oct 2015
Last updated
19 Jul 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Schurrle SB, Eberlein U, Ansquer C, Beauregard JM, Durand-Gasselin L, Gronbaek H, Haug A, Hicks RJ, Lenzo NP, Navalkissoor S, Nicolas GP, Pais B, Volteau M, Wild D, McEwan A, Lassmann M. Dosimetry and pharmacokinetics of [177Lu]Lu-satoreotide tetraxetan in patients with progressive neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2024 Jul;51(8):2428-2441. doi: 10.1007/s00259-024-06682-1. Epub 2024 Mar 26.

    PubMed 38528164

  • Wild D, Gronbaek H, Navalkissoor S, Haug A, Nicolas GP, Pais B, Ansquer C, Beauregard JM, McEwan A, Lassmann M, Pennestri D, Volteau M, Lenzo NP, Hicks RJ. A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):183-195. doi: 10.1007/s00259-023-06383-1. Epub 2023 Sep 18.

    PubMed 37721581

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Satoreotide tetraxetan, Amino acid solution and Antiemetic in people with Neuroendocrine Tumors, run by Ipsen at 9 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Australia, United States, Austria, Canada, Denmark and 3 more countries. 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 19 Jul 2023). 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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs (time frame: From the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, maximum of 33 months). 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?

On the ClinicalTrials.gov record for NCT02592707, 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 19 Jul 2023.

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