Add-Aspirin: A phase III, double-blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non metastatic solid tumours.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University College London

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Jul 2024 → ongoing

Decision date (initial)

2024-07-01

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511306-23-00

EudraCT number

2013-004398-28

ClinicalTrials.gov

NCT02804815

ISRCTN

ISRCTN74358648

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess whether regular aspirin use after standard therapy prevents recurrence and prolongs survival in participants with non-metastatic common solid tumours.

Secondary objectives 1

1. In all participants secondary outcome measures will include adherence, toxicity including serious haemorrhage, and cardiovascular events, as well as some tumour site-specific secondary outcome measures.

Conditions and MedDRA coding

Breast cancer, colon cancer, rectal cancer, stomach cancer, oesophageal cancer, prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Breast cohort: 1. Men or women with histologically confirmed invasive breast cancer. a. Patients with synchronous unilateral breast tumours are eligible based on the characteristics of the highest staged tumour. 2. Patients have undergone complete primary invasive tumour excision with clear radial margins as judged by the multidisciplinary team. 3. Surgical staging of the axilla must have been undertaken by sentinel node biopsy, axillary sampling or dissection. 4. In those patients with a positive sentinel node biopsy: a. If 1, 2 or 3 nodes are positive, subsequent management of the axilla (with surgery, radiotherapy or no further intervention) should follow institutional policy. If axillary surgery is to be undertaken, this should be completed prior to registration. b. If 4 or more nodes are involved, patients must have undergone completion axillary node dissection. 5. Radiotherapy: a. Patients who have undergone breast-conserving surgery should receive adjuvant radiotherapy. b. Patients who have undergone mastectomy should receive radiotherapy if they have more than 3 axillary lymph nodes involved. c. Patients who have undergone mastectomy and have T3 tumours and/or 1, 2 or 3 involved lymph nodes may (or not) receive radiation as per institutional practice. 6. Final histology must fall within at least one of these groups: a. For patients not receiving neoadjuvant chemotherapy: i. Node positive, or, ii. Node negative with high-risk features, defined as two or more of:  ER negative (Allred score <3/8 or negative according to institutional criteria)  HER2 positive  Grade 3  Lymphovascular invasion present  Age less than 35  Oncotype Dx score of >25  Prosignia score (PAM50) of >60 -Patients are permitted to have had neoadjuvant endocrine therapy for up to 6 months, as long as final surgical pathology falls within one of the above two groups. -In the above definitions patients with micrometastases should be regarded as node positive. Patients with isolated tumour cells should be regarded as node negative. b. Patients who have received neo-adjuvant chemotherapy or radiotherapy must fall into one of the following 3 categories: i. Hormone receptor negative and HER2 negative tumour AND has not achieved a pathological complete response, or, ii. A HER2 positive tumour (any hormone receptor status) AND not achieved a pathological complete response, or, iii. A hormone receptor positive, HER2 negative tumour which is grade 3 AND has not achieved a pathological complete response. 7. Patients who received standard neo-adjuvant and/or adjuvant chemotherapy or radiotherapy are eligible. Timing of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. (For confirmation of standard therapy, please contact MRC CTU at UCL). 8. Known HER2 and ER status. 9. No clinical or radiological evidence of residual or distant disease according to routine practice staging tests. 10. Participants may receive endocrine therapy, trastuzumab and be planned to receive neratinib according to standard practice concomitant with trial participation. All participants with ER positive disease should be planned to undergo a minimum of 5 years of adjuvant endocrine therapy using standard agents or as part of an agreed trial. 11. Patients who are already participating (or have participated) in other primary treatment trials may be eligible but this must be agreed in advance with the relevant trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. If a potential participant is enrolled in a trial that is not listed, this should be discussed with the MRC CTU at UCL or TMC (India) prior to registration. 12. WHO performance status 0, 1 or 2. 13. Written informed consent.
2. Colorectal cohort: 1. Histologically confirmed, stage II or stage III (see appendix IV) adenocarcinoma of the colon or rectum* and patients who have undergone resection of liver metastases (at any time) with clear margins and no residual metastatic disease as judged by the multidisciplinary team 2. Patients with synchronous colorectal tumours if one of the tumours is at least stage II or III. 3. Serum CEA ideally ≤1.5 x upper limit of normal (ULN). Participants outside of this range should be discussed with the MRC CTU at UCL on an individual basis. 4. Have undergone curative (R0) resection with clear margins (margins ≥1mm or as judged by the multidisciplinary team). 5. Patients who have received standard neo-adjuvant and/or adjuvant treatment or therapy within an agreed trial. Timing of registration and starting run-in treatmentin terms of the treatment pathway should be as described in section 4.2. (For confirmation of standard therapy, please contact MRC CTU at UCL). 6. No clinical or radiological evidence of residual or distant disease according to routine practice staging tests. 7. Patients with known Lynch Syndrome are eligible.** 8. Patients who are already participating (or have participated) in other primary treatment trials may be eligible but this must be agreed in advance with the relevant trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. If a potential participant is enrolled in a trial that is not listed, this should be discussed with the MRC CTU at UCL or TMC (India) prior to registration. 9. WHO performance status 0, 1 or 2. 10. Written informed consent.
3. Gastro-oesophageal cohort: 1. Patients with histologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous cell cancer of the oesophagus, gastro-oesophageal junction or stomach. 2. Patients will have undergone treatment with curative intent, either: (i) surgery, (ii) radical chemoradiotherapy, (iii) salvage surgery following recurrence after radical chemoradiotherapy or (iv) neo-adjuvant chemoradiotherapy followed by surgery. 3. Patients who have undergone surgery with curative intent must have either: a. A curative (R0) resection with clear margins (margin ≥1mm or as judged by the multidisciplinary team). b. An R1 resection with circumferential margin microscopically positive within 1mm in patients who have undergone an oesophagectomy or oesophagogastrectomy. 4. Patients with M1 nodal disease, where the involved lymph nodes have been encompassed within a radical radiotherapy field, are eligible. 5. Patients who have received standard neo-adjuvant and/or adjuvant treatment or therapy within an agreed trial are eligible. Timing of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. (For confirmation of standard therapy, please contact MRC CTU at UCL). 6. No clinical or radiological evidence of residual or distant disease according to routine practice staging tests. 7. In the UK and Republic of Ireland: Those who have undergone a partial gastrectomy or oesophagectomy should be prescribed a proton pump inhibitor for the duration of the trial where no clinical contraindication exists. 8. Patients who are already participating (or have participated) in other primary treatment trials may be eligible but this must be agreed in advance with the relevant trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. If a potential participant is enrolled in a trial that is not listed, this should be discussed with the MRC CTU at UCL or TMC (India) prior to registration. 9. WHO performance status 0, 1 or 2. 10. Written informed consent.
4. Prostate cohort: 1. Men with histologically confirmed, node negative, non-metastatic adenocarcinoma, with clinical or radiological stagingof the prostate T1-3b, N0. See appendix VII for TNM staging definitions. 2. Have undergone curative treatment, either a. Radical prostatectomy. b. Radical radiotherapy (external beam or brachytherapy). c. Salvage radiotherapy following a rise in PSA after radical prostatectomy. 3. Intermediate or high risk according to D’Amico classification93 (prior to radical treatment, see table 3). Also, patients who are low risk prior to prostatectomy but whose prostatectomy histology shows upstaging up to pT3b, or a higher Gleason score of 7 or greater are also eligible, including those with microscopic N1 disease provided any additional ADT is not planned for more than 3 years. 4. WHO performance status 0, 1 or 2. 5. Written informed consent. Depending on the curative treatment pathway, participants must additionally satisfy the following: (a) Prostatectomy patients 6. Open, laparoscopic or robotic radical prostatectomy. 7. a. Men treated with immediate adjuvant radiotherapy are eligible. Timing of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. b. In men entering following surgery without adjuvant radiotherapy, PSA at 6-weeks post-surgery should be ≤0.1ng/ml and should remain at this level at the time of entry into the trial, with timing of entry as described in section 4.2. For Indian participants registering before 6 weeks, PSA ≤0.1ng/ml should be confirmed at the time of randomisation. 8. Men receiving neo-adjuvant and/or adjuvant hormone therapy (LHRH agonists, LHRH antagonists, bicalutamide monotherapy) are eligible, provided the planned duration of adjuvant therapy is a maximum of three years. Treatment can be ongoing at the time of registration/randomisation to Add-Aspirin. (b) Radical radiotherapy patients 9. Men receiving neo-adjuvant and/or adjuvant hormone therapy (LHRH agonists, LHRH antagonists, bicalutamide monotherapy) are eligible provided the planned duration of adjuvant therapy is a maximum of three years.This treatment may be ongoing at the time of registration in Add-Aspirin. 10. Timing of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. (c) Salvage radiotherapy patients (following rise in PSA after previous radical prostatectomy) 11. Men treated with salvage radiotherapy following a rise in PSA are eligible. Timing of registration and starting run-in treatment in terms of the treatment pathway should be as described in section 4.2. 12. Men receiving neo-adjuvant and/or adjuvant hormone therapy (LHRH agonists, LHRH antagonists, bicalutamide monotherapy) are eligible provided the planned duration of adjuvant therapy is a maximum of three years. This treatment may be ongoing at the time of registration in Add-Aspirin.

Exclusion criteria 4

1. Breast cohort: 1. Metastatic or bilateral breast cancer. 2. Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix I for list of medications not permitted in the trial). • Regular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks • Previous regular use of aspirin ≥5 years ago is acceptable. Any previous regular aspirin use within the last 5 years should be discussed with the MRC CTU at UCL who will advise on eligibility on a case-by-case basis • Current NSAID use is defined as taking any NSAID for more than a week in the preceding month • If investigators feel that these definitions may unfairly exclude a participant, this can be discussed with the MRC CTU at UCL and a case by case decision will be made 3. A past history of adverse reaction or hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma, that is exacerbated by use of NSAIDs. 4. Current use of anti-coagulants. 5. Current or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy. 6. Active or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of the bleeding has been surgically removed. 7. Active or previous history of inflammatory bowel disease. 8. History of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2. 9. Previous invasive or non-invasive malignancy except: a. DCIS where treatment consisted of resection alone. b. Cervical carcinoma in situ where treatment consisted of resection alone. c. Basal cell carcinoma where treatment consisted of resection alone or radiotherapy. d. Superficial bladder carcinoma where treatment consisted of resection alone or with a single installation of intravesical chemotherapy or with BCG treatment. e. Other cancers where the patient has been disease-free for ≥15 years. f. Other cancers with very low potential for recurrence can be discussed with MRC CTU at UCL where eligibility will be considered on an individual basis. 10. Any other condition (physical or psychological) which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, and patients with a high risk of mortality from another cause within the trial treatment period. 11. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency. 12. Known lactose intolerance. 13. LFTs greater than 1.5x the upper limit of normal (with no evidence of residual or metastatic disease) unless the participant has been discussed with the MRC CTU at UCL and the Trial Management Group (TMG) agrees that they are suitable for the trial. This will be decided on a case-by-case basis. Please refer to http://www.addaspirintrial.org/information-for-centres/faqs/ for guidance. 14. Anticipated difficulties in complying with trial treatment or follow-up schedules. 15. <16years old in the UK and Republic of Ireland or <18 years old in India. 16. Participants in other treatment trials where this has not been agreed in advance by both trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. For all other trials, this should be discussed with the Trial Managers at the MRC CTU at UCL in the first instance. 17. Pregnant or breast feeding, or intending to become pregnant or breast feed during the trial treatment period. Participants should agree to inform the trial team if they subsequently become pregnant, or plan to become pregnant, whilst they are still receiving treatment in the trial (see section 5.4.4).
2. Colorectal cohort: 1. Proven (or clinically suspected) metastatic disease (patients who have undergone resection of liver metastases (at any time) with clear margins and no residual metastatic disease are eligible). 2. Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix I for list of medications not permitted in the trial). • Regular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks • Previous regular use of aspirin ≥5 years ago is acceptable. Any previous regular aspirin use within the last 5 years should be discussed with the MRC CTU at UCL who will advise on eligibility on a case-by-case basis • Current NSAID use is defined as taking any NSAID for more than a week in the preceding month • If investigators feel that these definitions may unfairly exclude a participant, this can be discussed with the MRC CTU at UCL and a case by case decision will be made 3. A past history of adverse reaction/hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma that is exacerbated by use of NSAIDs. 4. Current use of anti-coagulants. 5. Current or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy. 6. Active or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of the bleeding has been surgically removed. 7. Active or previous history of inflammatory bowel disease. 8. History of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2. 9. Previous invasive or non-invasive malignancy except: a. DCIS where treatment consisted of resection alone. b. Cervical carcinoma in situ where treatment consisted of resection alone. c. Basal cell carcinoma where treatment consisted of resection alone or radiotherapy. d. Superficial bladder carcinoma where treatment consisted of resection alone or with a single installation of intravesical chemotherapy or with BCG treatment. e. Other cancers where the patient has been disease-free for ≥15 years. f. Other cancers with very low potential for recurrence can be discussed with MRC CTU at UCL where eligibility will be considered on an individual basis. 10. Any other condition (physical or psychological) which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, and patients with a high risk of mortality from another cause within the trial treatment period. 11. Known G6PD deficiency. 12. Known lactose intolerance. 13. LFTs greater than 1.5x the upper limit of normal (with no evidence of residual or metastatic disease) unless the participant has been discussed with the MRC CTU at UCL and the TMG agrees that they are suitable for the trial. This will be decided on a case-by-case basis. Please refer to http://www.addaspirintrial.org/information-for-centres/faqs/ for guidance. 14. Anticipated difficulties in complying with trial treatment or follow-up schedules. 15. <16 years old in the UK and Republic of Ireland or <18 years old in India. 16. Participants in other treatment trials where this has not been agreed in advance by both trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. For all other trials, this should be discussed with the Trial Managers at the MRC CTU at UCL in the first instance. 17. Pregnant or breast feeding, or intending to become pregnant or breast feed during the trial treatment period. Participants should agree to inform the trial team if they subsequently become pregnant, or plan to become pregnant, whilst they are still receiving treatment in the trial (see section 5.4.4).
3. Gastro-oesophageal cohort: 1. Proven (or clinically suspected) residual or metastatic disease. 2. Patients with stage 1a oesophageal, gastric or gastro-oesophageal junction cancer are not eligible 3. Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix I for list of medications not permitted in the trial). • Regular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks • Previous regular use of aspirin ≥5 years ago is acceptable. Any previous regular aspirin use within the last 5 years should be discussed with the MRC CTU at UCL who will advise on eligibility on a case-by-case basis • Current NSAID use is defined as taking any NSAID for more than a week in the preceding month • If investigators feel that these definitions may unfairly exclude a participant, this can be discussed with the MRC CTU at UCL and a case by case decision will be made 4. A past history of adverse reaction/hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma that is exacerbated by use of NSAIDs. 5. Current use of anti-coagulants. 6. Current or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy. 7. Active or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of the bleeding has been surgically removed. 8. Active or previous history of inflammatory bowel disease. 9. History of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2. 10. Previous invasive or non-invasive malignancy except: a. DCIS where treatment consisted of resection alone. b. Cervical carcinoma in situ where treatment consisted of resection alone. c. Basal cell carcinoma where treatment consisted of resection alone or radiotherapy. d. Superficial bladder carcinoma where treatment consisted of resection alone or with a single installation of intravesical chemotherapy or with BCG treatment. e. Other cancers where the patient has been disease-free for ≥15 years. f. Other cancers with very low potential for recurrence can be discussed with MRC CTU at UCL where eligibility will be considered on an individual basis. 11. Any other condition (physical or psychological) which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, and patients with a high risk of mortality from another cause within the trial treatment period. 12. Known G6PD deficiency. 13. Known lactose intolerance. 14. LFTs greater than 1.5x the upper limit of normal (with no evidence of residual or metastatic disease) unless the participant has been discussed with the MRC CTU at UCL and the TMG agrees that they are suitable for the trial. This will be decided on a case-by-case basis. Please refer to http://www.addaspirintrial.org/information-for-centres/faqs/ for guidance. 15. Anticipated difficulties in complying with trial treatment or follow-up schedules. 16. <16years old in the UK and Republic of Ireland or <18 years old in India. 17. Participants in other treatment trials where this has not been agreed in advance by both trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. For all other trials, this should be discussed with the Trial Managers at the MRC CTU at UCL in the first instance. 18. Pregnant or breast feeding, or intending to become pregnant or breast feed during the trial treatment period. Participants should agree to inform the trial team if they subsequently become pregnant, or plan to become pregnant, whilst they are still receiving treatment in the trial (see section 5.4.4).
4. Prostate cohort: 1. Biopsy proven or radiologically suspected nodal involvement or distant metastases from prostate cancer. a. T4 patients are ineligible. 2. Adjuvant hormone therapy planned for >3years. 3. Bilateral orchidectomy. 4. Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication (see appendix I for list of medications not permitted in the trial). • Regular aspirin use is defined as taking aspirin more than twice in any given week for more than 4 consecutive weeks • Previous regular use of aspirin ≥5 years ago is acceptable. Any previous regular aspirin use within the last 5 years should be discussed with the MRC CTU at UCL who will advise on eligibility on a case-by-case basis • Current NSAID use is defined as taking any NSAID for more than a week in the preceding month. • If investigators feel that these definitions may unfairly exclude a participant, this can be discussed with the MRC CTU at UCL and a case by case decision will be made 5. A past history of adverse reaction/hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma that is exacerbated by use of NSAIDs. 6. Current use of anti-coagulants. 7. Current or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term therapy. 8. Active or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of the bleeding has been surgically removed. 9. Active or previous history of inflammatory bowel disease. 10. History of moderate or severe renal impairment, with eGFR<45ml/min/1.73m2. 11. Previous invasive or non-invasive malignancy except: a. Prostate cancer initially treated with prostatectomy and now being treated with salvage radiotherapy following a rise in PSA. b. Basal cell carcinoma where treatment consisted of resection alone or radiotherapy. c. Low grade superficial bladder carcinoma where treatment consisted of endoscopic resection alone or with a single installation of intravesical chemotherapy or with BCG treatment. d. Other cancers where the patient has been disease-free for ≥15 years. e. Other cancers with very low potential for recurrence can be discussed with MRC CTU at UCL where eligibility will be considered on an individual basis. 12. Any other condition (physical or psychological) which is associated with increased risk of aspirin-related morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, and patients with a high risk of mortality from another cause within the trial treatment period. 13. Known G6PD deficiency. 14. Known lactose intolerance. 15. LFTs greater than 1.5x the upper limit of normal (with no evidence of residual or metastatic disease) unless the participant has been discussed with the MRC CTU at UCL and the TMG agrees that they are suitable for the trial. This will be decided on a case-by-case basis. Please refer to http://www.addaspirintrial.org/information-for-centres/faqs/ for guidance. 16. Anticipated difficulties in complying with trial treatment or follow-up schedules. 17. <16years old in the UK and Republic of Ireland or <18 years old in India. 18. Participants in other treatment trials where this has not been agreed in advance by both trial teams. A current list of trials where co-enrolment has been approved is available at www.addaspirintrial.org. For further details see section 4.4. For all other trials, this should be discussed with the Trial Managers at the MRC CTU at UCL or TMC (India) prior to registration.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. All participants: Overall survival
2. Breast cancer participants: Invasive disease-free survival
3. Colorectal cancer: Disease-free survival
4. Gastro-oesophageal cancer: Disease-free survival
5. Prostate cancer: Biochemical recurrence-free survival

Secondary endpoints 20

1. Overall survival
2. Adherence
3. Toxicity
4. Serious haemorrhage
5. Serious vascular events
6. Thrombotic events
7. Diabetes and associated complications
8. Second malignancies
9. Age-related macular degeneration
10. Cognitive assessment
11. Dementia
12. Functional capacity
13. Exercise levels
14. Breast cancer-specific survival
15. Bone metastases-free survival (breast cancer)
16. IDFS-DCIS (invasive disease-free survival ductal carcinoma in-situ) (breast cancer)
17. Colorectal cancer-specific survival
18. Prostate cancer-specific survival
19. Time to initiation of salvage treatment (prostate cancer)
20. Bone metastases-free survival (prostate cancer)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University College London

Sponsor organisation

University College London

Address

19 Torrington Place, Gower Street Gower Street

City

London

Postcode

WC1E 6BT

Country

United Kingdom

Scientific contact point

Organisation

University College London

Contact name

Angela Meade

Public contact point

Organisation

University College London

Contact name

Angela Meade

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications