E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary and metastatic cancer. The active substance is a diagnostic agent that identifies angiogenesis associated with tumour growth. |
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E.1.1.1 | Medical condition in easily understood language |
This agent is for patients having a PET scan, to identify whether their tumour is growing. The patient's primary tumour will be in the kidney. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10050018 |
E.1.2 | Term | Renal cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038389 |
E.1.2 | Term | Renal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate whether changes of uptake on 18F-RGD PET-CT before, during and after anti-angiogenic therapy are associated with tumour response in patients with cancer. |
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E.2.2 | Secondary objectives of the trial |
• To assess the safety profile of fluciclatide • To evaluate whether changes of perfusion CT parameters are associated with response •To see if changes in perfusion CT parameters correlate with changes on 18F-RGD PET-CT •Evaluation of whether changes of uptake on 18F-RGD PET-CT post anti-angiogenic therapy are associated with tumour response between individual lesions •Evaluation of whether changes of uptake on 18F-RGD PET-CT post anti-angiogenic therapy are associated with clinical outcome
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A patient will be eligible for inclusion in this study if all of the following criteria apply: 1 Patients should have advanced or metastatic RCC confirmed by histological diagnosis 2 Patients considered suitable for therapy with TKI according to responsible clinician 3 Measurable tumour according to RECIST v1.1 criteria 4 Standard staging CT scan performed within 28 days of first research scan 5 The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment 6 Age ≥18 years 7 Adequate renal function (creatinine <1.25xULN) 8 Patient is able to tolerate and comply with scanning procedure 9 Patient is not lactating or pregnant 10 Patient is not known or suspected to have a hypersensitivity or allergy to Fluciclatide (18F) Injection or any of its components (including pABA). 11 Absence of any psychological, familial, sociological or geographical condition which in the opinion of the Investigator may potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 12 Able and willing to give informed consent |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in tumour uptake (% change in SUVmax) of fluciclatide related to tumour response (% change in size) within an individual patient as measured by repeat 18F-RGD PET-CT scans before during and after anti-angiogenic treatment
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before during and after anti-angiogenic treatment. There will be three scans, one at baseline, one after 4 weeks TKI treatment for renal cancer. The third and final scan will be after about 16 weeks to coincide with the routine re-staging CT scan. |
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E.5.2 | Secondary end point(s) |
a) Safety profile of fluciclatide measured using NCI CTCAE v 4.0 b) Changes of kinetic parameters (BV, BF and Ki) on CT perfusion imaging c) Absolute and relative tumour uptake and retention of fluciclatide d) Tumour response (% change in size) in individual lesions e) Progression free survival at 12 months – defined as time from last study scan to the date of disease progression or death due to any cause, whichever occurs first f) Overall survival at 12 months – defined as time from last study scan to date of death due to any cause
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoints a, b, c, and d will be measured at each of the three trial scanning visits.
Endpoints e) and f) will be measured at 12 months after their final study visit for the second set of research scans. Hence duration on study will be approximately 16 months for the renal cancer patients.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is defined as the last 12 month follow-up report of the last subject undergoing the trial. THis will be approx 12 months after the final study visit to see the the research team (which is the third PET /Perfusion CT restaging scanning and final study visit after 16 weeks TKI treatment. Patients will then be followed up for a further 12 months for survival and relapse status via their medical care team. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |