Clinical Trial Results:
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies
|
Summary
|
|
EudraCT number |
2017-004603-52 |
Trial protocol |
DK HU ES AT FI DE CZ GB IT |
Global end of trial date |
04 Oct 2021
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
09 Aug 2022
|
First version publication date |
09 Aug 2022
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
SGI-110-12
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT03603964 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Astex Pharmaceuticals, Inc,
|
||
Sponsor organisation address |
4420 Rosewood Drive, Suite 200, Pleasanton, United States, 94588
|
||
Public contact |
Clinical trial info SGI-110-012, Astex Pharmaceuticals, Inc., clinicaltrials@astx.com
|
||
Scientific contact |
Clinical trial info SGI-110-012, Astex Pharmaceuticals, Inc., clinicaltrials@astx.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
04 Oct 2021
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
04 Oct 2021
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
04 Oct 2021
|
||
Was the trial ended prematurely? |
Yes
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To provide ongoing treatment with guadecitabine for subjects who benefited from guadecitabine treatment in a previous Astex-sponsored clinical study and to obtain long-term safety information.
|
||
Protection of trial subjects |
All study subjects were required to read and sign an Informed Consent Form.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Jul 2018
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Australia: 1
|
||
Country: Number of subjects enrolled |
Canada: 3
|
||
Country: Number of subjects enrolled |
Finland: 1
|
||
Country: Number of subjects enrolled |
Czechia: 1
|
||
Country: Number of subjects enrolled |
France: 2
|
||
Country: Number of subjects enrolled |
Germany: 1
|
||
Country: Number of subjects enrolled |
Italy: 2
|
||
Country: Number of subjects enrolled |
Japan: 6
|
||
Country: Number of subjects enrolled |
Poland: 1
|
||
Country: Number of subjects enrolled |
Korea, Republic of: 2
|
||
Country: Number of subjects enrolled |
Spain: 6
|
||
Country: Number of subjects enrolled |
Taiwan: 1
|
||
Country: Number of subjects enrolled |
United States: 8
|
||
Worldwide total number of subjects |
35
|
||
EEA total number of subjects |
14
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
2
|
||
From 65 to 84 years |
29
|
||
85 years and over |
4
|
||
|
|||||||||||||||
|
Recruitment
|
|||||||||||||||
Recruitment details |
Subjects were enrolled in the study at 32 study centers in the United States, Spain, Italy, Canada, Japan, France, Germany, Poland, Finland, South Korea, Taiwan, Czech Republic and Australia from 18 July 2018 to 30 November 2020. | ||||||||||||||
|
Pre-assignment
|
|||||||||||||||
Screening details |
35 subjects who had participated in a previous Astex-sponsored guadecitabine clinical study (SGI-110-01 {NCT01261312}, SGI-110-04 {NCT02348489}, SGI-110-06 {NCT02920008}, and SGI-110-07 {NCT02907359}) and were still benefitting from the treatment at the time of database close of the original study, were enrolled in this extension study. | ||||||||||||||
|
Period 1
|
|||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
|
||||||||||||||
Blinding used |
Not blinded | ||||||||||||||
|
Arms
|
|||||||||||||||
|
Arm title
|
Guadecitabine | ||||||||||||||
Arm description |
Subjects received guadecitabine, subcutaneous (SC) injection on Days 1-5 of each 28-day cycle, at the same dose that they were receiving in the last cycle of their prior study or at a different dose as guided by the dose adjustment guidelines in the prior study protocol. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Guadecitabine
|
||||||||||||||
Investigational medicinal product code |
|||||||||||||||
Other name |
SGI-110
|
||||||||||||||
Pharmaceutical forms |
Injection
|
||||||||||||||
Routes of administration |
Subcutaneous use
|
||||||||||||||
Dosage and administration details |
SC injection administered on Days 1-5 of each 28-day cycle up to a maximum of 26 cycles.
|
||||||||||||||
|
|||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall Study
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Guadecitabine
|
||
Reporting group description |
Subjects received guadecitabine, subcutaneous (SC) injection on Days 1-5 of each 28-day cycle, at the same dose that they were receiving in the last cycle of their prior study or at a different dose as guided by the dose adjustment guidelines in the prior study protocol. | ||
|
|||||||
End point title |
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) [1] | ||||||
End point description |
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavourable and unintended sign (including a clinically significant abnormal finding in laboratory tests or other diagnostic procedures), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs are defined as events that occur or worsen on or after the date of the first study treatment (Cycle 1 Day 1 {C1D1}) until 30 days after the last dose of study treatment or the start of an alternative anti-cancer treatment, whichever occurs first. Safety population included all subjects who received any amount of study treatment.
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
From the start of study treatment until 30 days after the last dose of study treatment or prior to the subject receiving alternative anticancer therapy, whichever occurs first
|
||||||
| 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: No formal statistical hypotheses were tested for this end point. |
|||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||||
End point title |
Overall Survival | ||||||||
End point description |
Overall survival was defined as the number of days from the time of randomisation in the prior study to the date of death (regardless of cause). Subjects without a documented death date at the time of analysis were censored at the last date known alive. Survival time in days = (earliest of date of death or censoring) – (randomisation date in the prior study). Efficacy population included all subjects who received any amount of study treatment. 99999 indicates that the data is not available.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
From randomisation in the prior study to the date of death
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From the start of study treatment until 30 days after the last dose of study treatment or prior to the subject receiving alternative anticancer therapy, whichever occurs first.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Guadecitabine
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received guadecitabine, SC injection on Days 1-5 of each 28-day cycle, at the same dose that they were receiving in the last cycle of their prior study or at a different dose as guided by the dose adjustment guidelines in the prior study protocol. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No formal statistical hypotheses were tested for this end point. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The study was terminated due to the discontinuation of the overall guadecitabine development program, and not due to subject safety. | |||
