Clinical Trial Results:
A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer Unsuitable for Nephrectomy
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Summary
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EudraCT number |
2011-004562-16 |
Trial protocol |
GB |
Global end of trial date |
28 Feb 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Mar 2023
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First version publication date |
15 Mar 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ICR-CTSU/2011/10033
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Additional study identifiers
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ISRCTN number |
ISRCTN72679844 | ||
US NCT number |
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WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Sponsor Identification Number: CCR3587, ICR-CTSU Protocol Number: ICR-CTSU/2011/10033, REC reference: 12/LO/0639, IRAS: 98117 | ||
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Sponsors
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Sponsor organisation name |
The Institute of Cancer Research
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Sponsor organisation address |
15 Cotswold Road, London, United Kingdom, SM2 5NG
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Public contact |
Rebecca Lewis, The Institute of Cancer Research, 44 02087224081, apredict-icrctsu@icr.ac.uk
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Scientific contact |
Rebecca Lewis, The Institute of Cancer Research, 44 02087224081, apredict-icrctsu@icr.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 May 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Feb 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Feb 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Does treatment with axitinib stop previously untreated widespread kidney cancer that can't be surgically removed from getting worse for at least 6 months?
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Protection of trial subjects |
For trial entry and optional tissue donation, patients were given a verbal explanation, discussion and written information.
The Principal Investigator at each site was responsible for ensuring written informed consent was obtained for each patient.
Eligible patients were given as much time as they needed to consider and come to a decision about entering the trial, prior to giving consent for registration.
The patient information sheet, described fully which parties would have access to their identifiable personal information and patients were asked to give consent to this. The trial was overseen by an Independent Data Monitoring Committee, who reviewed the accumulating trial data and could recommend stopping the trial if there was any cause for concern about patient safety and if this were the case the patient's oncologist would be notified.
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Background therapy |
Renal cell carcinoma (RCC) is diagnosed in around 8,500 patients and accounts for approximately 3% of malignant disease annually in the UK. Many patients initially present with advanced or unresectable disease and up to 30% of patients treated by nephrectomy with curative intent for localised disease will relapse. The 5-year survival rate for metastatic RCC (mRCC) is less than 10%. Historically the prognosis for metastatic RCC was poor with a median survival of 6-8 months and reported response rates to chemotherapy and hormonal agents have been of the order of only 5-10%. Approximately half of RCC tumours have mutations in the Von Hippel-Lindau gene (VHL). VHL loss increases expression of the hypoxia-inducible factor alpha transcription factors (HIF-1α and HIF-2α). These factors regulate the expression of vascular endothelial growth factor (VEGF) and other molecules implicated in angiogenesis and invasion. These pathways are important in the pathophysiology of RCC although their roles are not fully understood. | ||
Evidence for comparator |
Nephrectomy is the mainstay of curative treatment for renal cell carcinoma and has also been shown to be of palliative benefit in metastatic disease. Two phase III trials, European Organization Research and Treatment of Cancer 30947 and SouthWest Oncology Group 8949, have demonstrated a survival benefit for nephrectomy followed by interferon versus interferon alone in patients with histologically confirmed progressive renal cell carcinoma and good performance status at presentation. Nephrectomy is generally a relatively safe and well-tolerated operation in experienced hands: a report from Memorial Sloan Kettering Cancer Centre (MSKCC) of 692 radical nephrectomies for renal cell cancer performed between 1995 and 2002 quotes a 3% procedure-related complication rate and 0.2% procedure-related mortality. Axitinib is a potent oral VEGFR2 and 3 inhibitor at picomolar concentrations and VEGFR1, PDGFRs and c-KIT inhibitor at low nanomolar concentrations. In phase II clinical trials, axitinib has shown efficacy in sorafenib and cytokine refractory mRCC patients. A recently reported phase III trial, showed superiority over sorafenib as second line therapy, leading to the licensing of axitinib in this indication by the US Food and Drug Administration (FDA) agency in January 2012. Axitinib was subsequently licensed for the same indication by the European Medicines Agency. Furthermore, the efficacy of axitinib is under evaluation in other tumour types, and has shown activity in lung, thyroid, and pancreatic cancers, and melanoma. | ||
Actual start date of recruitment |
01 Jun 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 65
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Worldwide total number of subjects |
65
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
36
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From 65 to 84 years |
29
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85 years and over |
0
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Recruitment
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Recruitment details |
Between 10 October 2012 and 23 December 2016, 65 participants were registered into A-PREDICT from 11 UK hospitals. | ||||||
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Pre-assignment
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Screening details |
Patients who met the eligibility criteria were recruited. Eligible patients had histologically confirmed metastatic renal cell carcinoma of predominant clear cell histology and who were not immediately clinically indicated for debulking nephrectomy (as judged by the treating clinician). Patients were over 18 with no prior systemic therapy. | ||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
N/A
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Arms
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Arm title
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Axitinib | ||||||
Arm description |
All participants started open-label axitinib on 5mg dose taken orally, twice daily, until clinical benefit was no longer derived | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Axitinib
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Investigational medicinal product code |
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Other name |
Inlyta
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Patients were prescribed a starting dose of 5mg tablet BID. Patients who tolerated axitinib with no adverse events related to study drug above CTCAE grade 2 for a consecutive 2-week period could have their dose increased by one dose level to a maximum of 10 mg BID (unless the patient’s blood pressure [BP] was >150/90 mm Hg or the patient was receiving antihypertensive medication). If the patient received antihypertensive medication and a dose escalation was clinically indicated TMG approval was obtained for the proposed dose escalation. No patient receiving antihypertensive medication could have an axitinib dose escalation without prior TMG approval.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial (overall period)
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Intention to treat
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
This population contains all people registered into the study (regardless of whether they were later found to be ineligible, a protocol deviator, never treated etc.).
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End points reporting groups
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Reporting group title |
Axitinib
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Reporting group description |
All participants started open-label axitinib on 5mg dose taken orally, twice daily, until clinical benefit was no longer derived | ||
Subject analysis set title |
Intention to treat
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
This population contains all people registered into the study (regardless of whether they were later found to be ineligible, a protocol deviator, never treated etc.).
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End point title |
Proportion of patients free from disease progression [1] | ||||||||||||
End point description |
The proportion of patients treated with axitinib who are free from disease progression 6 months from the commencement of treatment according to RECIST v1.1 criteria.
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End point type |
Primary
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End point timeframe |
6 months from the commencement of treatment
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a single arm study and no comparative analysis was performed, however the system expects at least 2 groups to be identified. All methods and options specified in the analysis section apply to statistical methods and summary measures to report and compare at least 2 independent groups, which is not the case in this single arm trial. There is no way of reporting one group inference and summary values without triggering an error or reporting inaccurate information. |
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End point title |
Best overall response | |||||||||||||||||||||
End point description |
Best overall response is defined as the best tumour response that is achieved during or within 30 days after termination of axitinib that is confirmed according to RECIST.
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End point type |
Secondary
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End point timeframe |
Best response as calculated while patients are on treatment.
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Progression free survival | ||||||||||||
End point description |
Progression-free survival (PFS) is measured from the date of registration until first date of either death or confirmed progressive disease according to RECIST 1.1. Time to last follow-up is used if patient has not progressed or died and PFS time for the patient is considered censored.
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End point type |
Secondary
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End point timeframe |
6 months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Overall survival | ||||||||||||
End point description |
OS is defined as time from registration to death from any cause. Patients who have not been reported to have died are censored at last follow-up.
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End point type |
Secondary
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End point timeframe |
Median survival time based on all follow-up available.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Proportion of patients who undergo nephrectomy | ||||||||||||
End point description |
The proportion of patients who undergo nephrectomy following registration as a result of treatment with axitinib will be reported.
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End point type |
Secondary
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End point timeframe |
Whilst patients are on treatment.
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Within 28 days of the patient receiving study drug.
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Adverse event reporting additional description |
Progression of the malignancy was not reported as a serious adverse event. Hospitalisation due to signs and symptoms of malignancy progression was not reported as a serious adverse event. Occurrences are counted as any subject reporting a particular AE at a visit where toxicity was assessed.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.0
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Reporting groups
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Reporting group title |
Axitinib
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Reporting group description |
This population contains all patients who received at least one dose of axitinib. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Aug 2012 |
Protocol amendment to trial assessments and drug dispensing schedule. An additional pregnancy test was included to be conducted within 3 days prior to commencing treatment. The timeframe for stopping axitinib prior to day 1 week 9 biopsy was extended from 7 days to 5-7 days. Timelines for response assessment and biopsy when the patient stopped trial treatment were inserted. The schedule of assessments was amended in line with these changes.
A “Subsequent Therapy” section was added confirm that “Participants for whom treatment is discontinued should be treated according to clinical circumstances and should be managed at the local clinician’s discretion.”
Addition of new participating centres. |
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25 Jan 2013 |
Amendment to the Patient Information Sheet and Consent Form relating to the frequency of hospital visits and details regarding participant biopsies.
Addition of new participating centres. |
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25 Oct 2013 |
The study Reference Safety Information (RSI) had been updated to the Summary of Medical Product Characteristics (SmPC), and any reference to the Investigator Brochure (IB) in the protocol had been replaced by SmPC. The protocol was revised throughout for consistency with the SmPC.
The protocol was updated to state that eligible patients included those with unresectable primary tumours, those with a large metastatic burden or those unfit for nephrectomy. Further changes were included to the timing of scheduled assessments and guidance around treatment interruptions.
Addition of new participating centres and a change in Principal Investigator at a participating centre. |
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16 May 2014 |
The protocol was amended to clarify that where a patient received antihypertensive medication and a dose escalation was clinically indicated, this was permitted with TMG approval on a case-by-case basis.
The urinalysis section of the protocol was amended allow an additional method in the assessment for proteinuria. Centres may use urinary protein:creatinine ratio (PCR). |
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13 May 2015 |
The protocol was amended to note the London Research Institute (LRI) had become part of the Francis Crick Institute (FCI); the addition of an exploratory endpoint to investigate any effect of treatment on the extent of inferior vena cava (IVC) venous tumour thrombus (VTT); provision to allow the use of prohibited medications in exceptional circumstances if approved by the Chief Investigator, and a minor correction to the translational sample schedule.
Change of principal investigator at an existing site. |
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26 Nov 2015 |
The protocol inclusion criteria were updated to state that adequate organ function can be defined by an AST or ALT reading rather than requiring both and that the baseline systolic BP readings must be ≤150 mm Hg in accordance with the current SmPC.
Change in Principal Investigator at an existing centre. |
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08 Nov 2016 |
The protcol exclusion criteria were update to include known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Guidance relating to dose modification for axitinib related adverse events; dose reduction for proteinuria; and concomitant therapy were added to the protocol in line with the new version of Reference Safety Information. Changes to dose reduction guidance for hypertension for consistency with systolic pressure guidance
Collection of fresh tissue for cell culture from London sites removed as no longer required
The Patient Information Sheet's Serious and Common side effects section was revised in light of updated Reference Safety Information. |
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24 Jan 2017 |
Closure to recruitment. A-PREDICT closed to recruitment on 23/12/2016 following feedback from the Independent Data Monitoring and Steering Committee, who met on the 01/12/2016. The IDMSC reviewed the number of A-PREDICT participants progression free at week 24 and advised recruitment should close as no further participants were required to assess the primary objective, 65 participants were recruited in total. the original sample size was 99 participants. The recommendation to close to recruitment was not based on any safety reasons. Participants receiving treatment at the time of closure continued on treatment as per protocol. |
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02 Nov 2018 |
Protocol amendment detailing the introduction of a new axitinib supply process following transfer of participants to commercial supply after expiration of the existing trial supply on 31/11/2018. |
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12 Jun 2019 |
Update to reference safety information.
The patient information sheet was updated in line with the new reference safety information and to include statement to
explain translational analysis of samples collected in A-PREDICT may occur outside of the Francis Crick Institute either in the UK or abroad. |
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02 Jun 2020 |
The reference safety information was updated due to the release of the axitinib (Inlyta) SmPC in which cholecystitis had been added as a common adverse event.
The protocol follow up schedule had been rationalised for patients who had been on treatment for a considerable amount of time as four weekly assessment was no longer clinically required after this duration on treatment. Hospital visits were aligned with scan frequency for the convenience of participants. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
