Clinical Trial Results:
A PHASE II STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT) OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER
Summary
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EudraCT number |
2012-000351-14 |
Trial protocol |
GB |
Global end of trial date |
22 Dec 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Dec 2017
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First version publication date |
20 Dec 2017
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Other versions |
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 |
PR201206
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01907009 | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Barts Health NHS Trust
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Sponsor organisation address |
5 Walden Street, London, United Kingdom, E1 2EF
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Public contact |
Jonathan Shamash, Barts Health NHS Trust, +44 0207 882 8761, bci-melcap@qmul.ac.uk
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Scientific contact |
Jonathan Shamash, Barts Health NHS Trust, +44 0207 882 8761, bci-melcap@qmul.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 |
22 Dec 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Dec 2016
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To determine the efficacy of intensified intravenous melphalan with autologous whole blood stem cell transplantation in patients with castration-resistant prostate cancer using Progression Free Survival rate
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Protection of trial subjects |
Patients were closely monitored as part of the clinical trial. Side effects were closely measured, and blood tests were taken before any administration of melphalan to ensure patient suitability to continue on the trial. As neutropenia was a known risk, bloods were taken every 24-48 hours if neutrophils were low to ensure close monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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: 29
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Worldwide total number of subjects |
29
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EEA total number of subjects |
29
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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) |
13
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From 65 to 84 years |
16
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85 years and over |
0
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Recruitment
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Recruitment details |
Between January 2013 and December 2016, 29 patients were recruited to the MELCAP trial. This was a single site study, being carried out at Barts Health NHS Trust. | ||||||
Pre-assignment
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Screening details |
No patients failed the screening period, with all 29 patients entering the trial. | ||||||
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 | ||||||
Arms
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Arm title
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Lenograstim plus melphalan | ||||||
Arm description |
intervention arm (single) | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Lenograstim
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Lenograstim will be administered over a period of 3 cycles (14 days per cycle).
Cycle 1:
Day -4 to -2 and Day 7-12: 10mcg/kg /day
Cycle 2:
Day 7-12 Lenograstim 10mcg/kg/day
Cycle 3:
Day 1-10 Lenograstim 263mcg/day
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Investigational medicinal product name |
Melphalan
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Melphalan is given on Day-1 of each cycle for three cycles. Each cycle is 14 days.
The doses given were 60 mg/m2 over 15 minutes in cycle 1 and 40 mg/m2 over 15 minutes in cycle 2 and cycle 3.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lenograstim plus melphalan
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Reporting group description |
intervention arm (single) |
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End point title |
Radiological and / symptomatic progression free survival (PFS) rate at 6-months [1] | ||||||||
End point description |
This analysis was not carried out due to early termination of the trial.
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End point type |
Primary
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End point timeframe |
PFS rate at 6 months
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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 trial terminated early prior to the full number of 39 patients being recruited. No statistical analysis has been carried out. |
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Notes [2] - Primary endpoint analysis was not carried out as the trial was terminated early. |
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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 |
Entire trial
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Adverse event reporting additional description |
Only treatment-related Grade 3 and above non serious AEs are reported here
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.02
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Reporting groups
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Reporting group title |
Lenograstim plus melphalan
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Reporting group description |
intervention arm (single) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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17 Aug 2012 |
Responses to conditions listed in conditional approval from REC and changes following non-acceptance from MHRA. Includes separating the two PIS for patients who have received Docetaxel and those who are Docetaxel naive. Other administrative changes. |
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15 Oct 2012 |
Changes requested by MHRA to contraindications in exclusion criteria based on SmPCs. |
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29 Jan 2013 |
Change in eligibility criteria to allow patients who had been in a hormone or steroid clinical trials within previous 30 days to enter. |
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29 Oct 2013 |
Changes to dosing of lenograstim and introduction of dose rounding document to help pharmacists dispense correct dose; introduction of patient diary card. |
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26 Oct 2015 |
Clarification for the exempt concomitant medications and how to record them. Clarification on the end of trial definition. Name change of sponsor’s representative to Barts Health NHS Trust. Clarification on exempt SAEs. The end of trial date has been extended 01/09/2019 to complete the overall accrual for the trial. |
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22 Jul 2016 |
Temporary halt to recruitment following licensing issue for autologous blood transfusions held by Barts Health NHS Trust. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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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. | |||||||
No endpoint analyses are included in these results due to early termination of this trial. Adverse events are reported for data collected until the date of early termination. |