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| Name | Class |
|---|---|
| Prostate Cancer UK | OTHER |
| Boehringer Ingelheim | INDUSTRY |
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The WINGMEN trial aims to understand how a hormone-like protein called insulin-like growth factor (IGF) helps prostate cancers grow and become aggressive. IGF is required for normal development, and also helps cancers grow and spread. Men with high blood IGF are at increased risk of developing prostate cancer, and tall men are more likely to get aggressive prostate cancer. The WINGMEN trial will recruit 30 men with prostate cancer who have been offered an operation to remove the prostate. Most men have to wait 4-5 weeks between a decision to have prostate removal surgery, and actually having the operation. In this 4-5 week window we will offer treatment with a new IGF-blocker drug called xentuzumab. The drug is provided by Boehringer Ingelheim and the trial is funded by Prostate Cancer UK.
Xentuzumab will be given as an outpatient by once weekly intravenous infusion (drip) in the Early Phase Clinical Trials Unit, Oxford Cancer Centre, Churchill Hospital. In other trials, xentuzumab is being tested in patients with advanced cancer, and is proving to be well-tolerated. After the 4-week treatment, WINGMEN trial patients will have routine prostate removal surgery. Samples of blood and prostate cancer that are surplus to diagnostic need will be taken from the diagnostic prostate biopsy (pre-xentuzumab) and the cancer removed at surgery (after xentuzumab) for research tests. These samples will be compared to measure how effectively xentuzumab reduces signs of tumour growth, and identify which genes and proteins are switched on or off by xentuzumab, and which may therefore be important in helping IGF promote prostate cancer growth. The information we get from the WINGMEN trial may help us to improve treatment of men with prostate cancer, with the long-term aim of reducing the risk of aggressive prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xentuzumab | Experimental | All patients will be allocated to receive Xentuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xentuzumab | Drug | The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change of Phospho-IGF-1R Positive Tumour Cells Following Treatment With Xentuzumab | Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained with phospho-IGF-1R. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-IGF-1R in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab. | From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total. |
| Percentage Change of Phospho-S6 Positive Tumour Cells Following Treatment With Xentuzumab | Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained by phospho-S6. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-S6 in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab. | From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had at Least 4 Doses of Xentuzumab and Proceeded to Have Surgery Per the Protocol Schedule | This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting. | From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total. |
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Inclusion Criteria:
A patient will be eligible for inclusion in this study if all of the following criteria apply.
Laboratory Test Value required Hemoglobin (Hb) ≥90g/L White Blood Count (WBC) >2.5 x 10*9/L Absolute Neutrophil Count (ANC) ≥ 1.5 x10*9/L Platelet count ≥ 100 x 10*9/L AST, ALT, and alkaline phosphatase ≤ 2.5 x upper limit of normal eGFR* ≥30ml/min
*eGFR calculated by Cockcroft & Gault formula,
Exclusion Criteria:
A patient will not be eligible for the trial if any of the following apply:
based on gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Simon Lord, Prof | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Churchill Hospital, Oxford University Hospitals | Oxford | OX3 7LE | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xentuzumab | All patients will be allocated to receive Xentuzumab Xentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xentuzumab | All patients will be allocated to receive Xentuzumab Xentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change of Phospho-IGF-1R Positive Tumour Cells Following Treatment With Xentuzumab | Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained with phospho-IGF-1R. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-IGF-1R in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab. | Units given accounts for a pre-treatment and post-treatment sample per participant. Number analysed excludes samples from 6 participants that were missing either the pre-treatment or post-treatment sample, or could not be analysed for other reasons. | Posted | Mean | Full Range | Percentage change Phospho-IGF-1R+ cells | From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total. | Tissue samples | Tissue samples |
|
From consent to end of study visit (up to 19 weeks).
Adverse Event data was collected during trial visits from investigator-led assessments as specified in the protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xentuzumab | All patients were allocated to receive the study IMP, Xentuzumab. Xentuzumab is a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood & Lymphatic System Disorders | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Simon Lord | University of Oxford | 01865 227212 | simon.lord@oncology.ox.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2022 | Aug 21, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2024 | Aug 21, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C588089 | xentuzumab |
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This is a phase 0 'window of opportunity' study testing whether xentuzumab blocks IGF signalling and markers of growth in men with localised prostate cancer scheduled for radical prostatectomy
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| Median Delay in Surgery in Participants Who Had More Than 4 Doses of Xentuzumab (and Whose Surgery Was Delayed by Factors Other Than Trial Treatment) |
All participants who had more than 4 doses of xentuzumab were considered to have had their surgery delayed by factors other than trial treatment. Per protocol, all participants who had delayed surgery received additional weekly doses of xentuzumab. Reason for delay was not recorded as part of the study dataset. This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting. |
| From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total. |
| Number of Patients Experiencing an Adverse Event (AE) or Serious Adverse Event (SAE) While On-trial | This endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting. AEs & SAEs were graded using CTCAE v5.0, with higher grades considered to be worse outcomes. | From consent at week -1 to the end of study visit at up to 19 weeks |
| Number of Patients With Any Adverse Event Assessed as Treatment-Related (TRAE) While On-trial | Number of patients with any TRAE from the time of consent to the end of study visit. TRAEs are AEs that are investigator-determined to be definitely, probably or possibly related to treatment with xentuzumab and graded using CTCAE v5.0, with higher grades considered to be worse outcomes. This endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting. | From consent at week -1 to the end of study visit at up to 19 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Xentuzumab |
All patients will be allocated to receive Xentuzumab Xentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance |
|
|
| Primary | Percentage Change of Phospho-S6 Positive Tumour Cells Following Treatment With Xentuzumab | Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained by phospho-S6. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-S6 in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab. | Units analysed describes pre-treatment and post-treatment sample for each participant. Number analysed excludes 10 participants that were missing either the pre-treatment or post-treatment sample, or could not be analysed for other reasons. | Posted | Mean | Full Range | Percentage change of Phospho-S6+ cells | From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total. | Tissue samples | Tissue samples |
|
|
|
| Secondary | Number of Participants Who Had at Least 4 Doses of Xentuzumab and Proceeded to Have Surgery Per the Protocol Schedule | This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting. | Total number of participants who had at least 4 doses of xentuzumab. Excludes one registered patient who progressed prior to surgery and came off trial. | Posted | Count of Participants | Participants | From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total. |
|
|
|
| Secondary | Median Delay in Surgery in Participants Who Had More Than 4 Doses of Xentuzumab (and Whose Surgery Was Delayed by Factors Other Than Trial Treatment) | All participants who had more than 4 doses of xentuzumab were considered to have had their surgery delayed by factors other than trial treatment. Per protocol, all participants who had delayed surgery received additional weekly doses of xentuzumab. Reason for delay was not recorded as part of the study dataset. This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting. | Number of participants who had more than 4 Doses of xentuzumab. | Posted | Median | Full Range | weeks | From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total. |
|
|
|
| Secondary | Number of Patients Experiencing an Adverse Event (AE) or Serious Adverse Event (SAE) While On-trial | This endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting. AEs & SAEs were graded using CTCAE v5.0, with higher grades considered to be worse outcomes. | All participants registered to take part in the WINGMEN trial. All participants received xentuzumab. | Posted | Count of Participants | Participants | From consent at week -1 to the end of study visit at up to 19 weeks |
|
|
|
| Secondary | Number of Patients With Any Adverse Event Assessed as Treatment-Related (TRAE) While On-trial | Number of patients with any TRAE from the time of consent to the end of study visit. TRAEs are AEs that are investigator-determined to be definitely, probably or possibly related to treatment with xentuzumab and graded using CTCAE v5.0, with higher grades considered to be worse outcomes. This endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting. | All participants registered to take part in the WINGMEN trial. All participants received xentuzumab. | Posted | Count of Participants | Participants | From consent at week -1 to the end of study visit at up to 19 weeks |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 24 |
| 27 |
| Eye disorders | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| General Disorders & Administration Site Conditions | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Infections & Infestations | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Injury; poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Metabolism & Nutrition Disorders | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Musculoskeletal & Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Any SAE, Highest Grade 3,4,5 (CTCAE v5.0) |
|
| No AEs or SAEs reported |
|