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Clinical Trial Results:
PHARMACOGENETIQUE DE LA GEMCITABINE : ETUDE DE L’IMPACT DU POLYMORPHISME GENETIQUE DE LA CYTIDINE DEAMINASE (CDA) SUR LA TOXICITE ET L’EFFICACITE THERAPEUTIQUE DANS LES ADENOCARCINOMES PANCREATIQUES RESEQUES

Summary
EudraCT number	2010-022987-11
Trial protocol	FR
Global end of trial date	15 Sep 2016

Results information
Results version number	v1(current)
This version publication date	08 Apr 2022
First version publication date	08 Apr 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

FFCD 1004

ISRCTN number

US NCT number

NCT01416662

WHO universal trial number (UTN)

Sponsor organisation name

Fédération Francophone de Cancérologie Digestive (FFCD)

Sponsor organisation address

7 Bd Jeanne d'Arc, Dijon, France, 21000

Public contact

Karine Le Malicot Head of Biostatistics, Fédération Francophone de Cancérologie Digestive (FFCD), karine.le-malicot@u-bourgogne.fr

Scientific contact

Karine Le Malicot Head of Biostatistics, Fédération Francophone de Cancérologie Digestive (FFCD), karine.le-malicot@u-bourgogne.fr

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 Jan 2015

Is this the analysis of the primary completion data?

Yes

Primary completion date

15 Jan 2015

Global end of trial reached?

Yes

Global end of trial date

15 Sep 2016

Was the trial ended prematurely?

Main objective of the trial

Evaluer la capacité du CDA à prédire la survenue d’une toxicité hématologique sévère (grade 3-4), précoce (lors des 2 premiers cycles), induite par la gemcitabine.

Protection of trial subjects

The study was done in accordance with the Declaration of Helsinki (amended 2000) and the International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) Note for Guidance on Good Clinical Practice and approved by the appropriate Ethics Committees.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Jul 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 120

Worldwide total number of subjects

120

EEA total number of subjects

120

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Between July 2011 and June 2013, 120patients were enrolled in the trial by 31centers in France.

Screening details

Before enrollement, standard examinations (biological, clinical, ECG) were done. In terms of imaging, abdominal and thoracic computed tomography scan or MRI were also done.

Period 1 title

Enrolled patients (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Gemcitabin Arm

Arm description

Adjuvant gemcitabine-monotherapy as follows: 30-minutes IV-infusion of 1000 mg/m2 every week for 3 consecutive weeks followed by one week off for 6 courses

Arm type

Experimental

Investigational medicinal product name

Gemcitabin

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Adjuvant gemcitabine-monotherapy as follows: 30-minutes IV-infusion of 1000 mg/m2 every week for 3 consecutive weeks followed by one week off for 6 courses

Number of subjects in period 1	Gemcitabin Arm
Started	120
Evaluable patients	109
Completed	109
Not completed	11
No matching reasons found	1
No CDA determination	10

Baseline characteristics

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Reporting group title

Enrolled patients

Reporting group description

Reporting group values	Enrolled patients	Total
Number of subjects	120	120
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	52	52
From 65-84 years	68	68
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	65.85 ( 10.05 )	-
Gender categorical
Units: Subjects
Female	46	46
Male	74	74

Subject analysis set title

Evaluable patients

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Is defined as all patients with a defined CDA phenotype-genotype who have received at least one administration of gemcitabine (regardless of dose).

Subject analysis set title

CDA <=1.3U/mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Patients treated with CDA <1.3U/mg

Subject analysis set title

CDA >1.3U/mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Patients treated with CDA >1.3 U/mg

Subject analysis sets values	Evaluable patients	CDA <=1.3U/mg	CDA >1.3U/mg
Number of subjects	109	5	104
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	47	2	45
From 65-84 years	62	3	59
85 years and over	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	65.74 ( 10.2 )	( )	( )
Gender categorical
Units: Subjects
Female	41
Male	68

End points

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Reporting group title

Gemcitabin Arm

Reporting group description

Adjuvant gemcitabine-monotherapy as follows: 30-minutes IV-infusion of 1000 mg/m2 every week for 3 consecutive weeks followed by one week off for 6 courses

Subject analysis set title

Evaluable patients

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Is defined as all patients with a defined CDA phenotype-genotype who have received at least one administration of gemcitabine (regardless of dose).

Subject analysis set title

CDA <=1.3U/mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Patients treated with CDA <1.3U/mg

Subject analysis set title

CDA >1.3U/mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Patients treated with CDA >1.3 U/mg

Primary: Capability of CDA to predict occurence of severe toxicities

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End point title

Capability of CDA to predict occurence of severe toxicities ^[1]

End point description

End point type

Primary

End point timeframe

Within 2 months of treatment

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 study is a single-arm study so no comparison with a another arm.

End point values	Evaluable patients	CDA <=1.3U/mg	CDA >1.3U/mg
Number of subjects analysed	5	104	109
Units: Patients
Severe hematological toxicity	1	24	25
No severe hematological toxicity	4	80	84

No statistical analyses for this end point

Secondary: Overall Survival

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End point title

Overall Survival

End point description

End point type

Secondary

End point timeframe

Until the end of the follow-up or death (Whatever the cause)

End point values	Gemcitabin Arm
Number of subjects analysed	120
Units: patients
Death	55
Alive	65

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All AEs occurring in the course of the study, from the signature of the informed consent form and until 30 days after the last dose of the study drug were reported by the investigator.

Assessment type

Systematic

Dictionary name

NCi-CTC

Dictionary version

4.0

Reporting group title

Safety population

Reporting group description

All the patients treated with at least one dose of treatment

Serious adverse events	Safety population
Total subjects affected by serious adverse events
subjects affected / exposed	14 / 119 (11.76%)
number of deaths (all causes)	55
number of deaths resulting from adverse events	0
Investigations
Hepatic function abnormal
subjects affected / exposed	1 / 119 (0.84%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Injury, poisoning and procedural complications
Eventration
subjects affected / exposed	1 / 119 (0.84%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Vascular disorders
Arterial thrombosis
subjects affected / exposed	1 / 119 (0.84%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
Alteration of general conditions
subjects affected / exposed	2 / 119 (1.68%)
occurrences causally related to treatment / all	2 / 2
deaths causally related to treatment / all	0 / 0
Hyperthermia
subjects affected / exposed	3 / 119 (2.52%)
occurrences causally related to treatment / all	3 / 3
deaths causally related to treatment / all	0 / 0
Members Oedema
subjects affected / exposed	2 / 119 (1.68%)
occurrences causally related to treatment / all	2 / 2
deaths causally related to treatment / all	0 / 0
Blood and lymphatic system disorders
Anemia
subjects affected / exposed	1 / 119 (0.84%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Neutropenia
subjects affected / exposed	1 / 119 (0.84%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Pancreatitis acute
subjects affected / exposed	1 / 119 (0.84%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
pneumopathy
subjects affected / exposed	1 / 119 (0.84%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Pulmonary fibrosis
subjects affected / exposed	1 / 119 (0.84%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Metabolism and nutrition disorders
Anorexia
subjects affected / exposed	1 / 119 (0.84%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Safety population
Total subjects affected by non serious adverse events
subjects affected / exposed	119 / 119 (100.00%)
Vascular disorders
Hypotension
subjects affected / exposed	6 / 119 (5.04%)
occurrences all number	6
Hypertension
subjects affected / exposed	7 / 119 (5.88%)
occurrences all number	7
General disorders and administration site conditions
Asthenia
subjects affected / exposed	93 / 119 (78.15%)
occurrences all number	93
Fever
subjects affected / exposed	34 / 119 (28.57%)
occurrences all number	34
Chills
subjects affected / exposed	17 / 119 (14.29%)
occurrences all number	17
Respiratory, thoracic and mediastinal disorders
Dyspnea
subjects affected / exposed	11 / 119 (9.24%)
occurrences all number	11
Cough
subjects affected / exposed	14 / 119 (11.76%)
occurrences all number	14
Investigations
Alanine aminotransferase increased
subjects affected / exposed	77 / 119 (64.71%)
occurrences all number	77
Aspartate aminotransferase increased
subjects affected / exposed	73 / 119 (61.34%)
occurrences all number	73
bilirubin increased
subjects affected / exposed	17 / 119 (14.29%)
occurrences all number	17
Creatinine renal clearance increased
subjects affected / exposed	8 / 119 (6.72%)
occurrences all number	8
White blood cell count decreased
subjects affected / exposed	90 / 119 (75.63%)
occurrences all number	90
Haemoglobin increased
subjects affected / exposed	9 / 119 (7.56%)
occurrences all number	9
Neutrophil count decreased
subjects affected / exposed	94 / 119 (78.99%)
occurrences all number	94
Platelet count decreased
subjects affected / exposed	63 / 119 (52.94%)
occurrences all number	63
Gamma-glutamyltransferase increased
subjects affected / exposed	46 / 119 (38.66%)
occurrences all number	46
Phosphatases alcalines increased
subjects affected / exposed	37 / 119 (31.09%)
occurrences all number	37
Weight decreased
subjects affected / exposed	7 / 119 (5.88%)
occurrences all number	7
Nervous system disorders
Headaches
subjects affected / exposed	11 / 119 (9.24%)
occurrences all number	11
Neuropathy
subjects affected / exposed	8 / 119 (6.72%)
occurrences all number	8
Paresthesia
subjects affected / exposed	7 / 119 (5.88%)
occurrences all number	7
Blood and lymphatic system disorders
Anemia
subjects affected / exposed	115 / 119 (96.64%)
occurrences all number	115
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	8 / 119 (6.72%)
occurrences all number	8
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	67 / 119 (56.30%)
occurrences all number	67
Oral mucositis
subjects affected / exposed	13 / 119 (10.92%)
occurrences all number	13
Nausea
subjects affected / exposed	67 / 119 (56.30%)
occurrences all number	67
Vomiting
subjects affected / exposed	34 / 119 (28.57%)
occurrences all number	34
Constipation
subjects affected / exposed	30 / 119 (25.21%)
occurrences all number	30
Stomach pain
subjects affected / exposed	9 / 119 (7.56%)
occurrences all number	9
Abdominal pain
subjects affected / exposed	42 / 119 (35.29%)
occurrences all number	42
Dyspepsia
subjects affected / exposed	6 / 119 (5.04%)
occurrences all number	6
Flatulence
subjects affected / exposed	6 / 119 (5.04%)
occurrences all number	6
Haemorrhoids
subjects affected / exposed	7 / 119 (5.88%)
occurrences all number	7
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	21 / 119 (17.65%)
occurrences all number	21
Pruritus
subjects affected / exposed	6 / 119 (5.04%)
occurrences all number	6
Rash
subjects affected / exposed	9 / 119 (7.56%)
occurrences all number	9
Renal and urinary disorders
Hematuria
subjects affected / exposed	13 / 119 (10.92%)
occurrences all number	13
Proteinuria
subjects affected / exposed	12 / 119 (10.08%)
occurrences all number	12
Musculoskeletal and connective tissue disorders
Dorsalgia
subjects affected / exposed	19 / 119 (15.97%)
occurrences all number	19
Myalgia
subjects affected / exposed	11 / 119 (9.24%)
occurrences all number	11
Arthralgia
subjects affected / exposed	6 / 119 (5.04%)
occurrences all number	6
cramps
subjects affected / exposed	11 / 119 (9.24%)
occurrences all number	11
Infections and infestations
Infection
subjects affected / exposed	13 / 119 (10.92%)
occurrences all number	13
Metabolism and nutrition disorders
Dysgeusia
subjects affected / exposed	8 / 119 (6.72%)
occurrences all number	8
Hyperglycaemia
subjects affected / exposed	25 / 119 (21.01%)
occurrences all number	25
Hyperkalaemia
subjects affected / exposed	18 / 119 (15.13%)
occurrences all number	18
Hypernatraemia
subjects affected / exposed	6 / 119 (5.04%)
occurrences all number	6
Hypoalbuminaemia
subjects affected / exposed	23 / 119 (19.33%)
occurrences all number	23
Hypocalcaemia
subjects affected / exposed	12 / 119 (10.08%)
occurrences all number	12
Hypokalaemia
subjects affected / exposed	13 / 119 (10.92%)
occurrences all number	13
Hyponatraemia
subjects affected / exposed	11 / 119 (9.24%)
occurrences all number	11

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/2630894

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Clinical Trial Results:
PHARMACOGENETIQUE DE LA GEMCITABINE : ETUDE DE L’IMPACT DU POLYMORPHISME GENETIQUE DE LA CYTIDINE DEAMINASE (CDA) SUR LA TOXICITE ET L’EFFICACITE THERAPEUTIQUE DANS LES ADENOCARCINOMES PANCREATIQUES RESEQUES

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Capability of CDA to predict occurence of severe toxicities

Primary: Capability of CDA to predict occurence of severe toxicities

Secondary: Overall Survival

Secondary: Overall Survival

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

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Clinical trials

Clinical Trial Results: PHARMACOGENETIQUE DE LA GEMCITABINE : ETUDE DE L’IMPACT DU POLYMORPHISME GENETIQUE DE LA CYTIDINE DEAMINASE (CDA) SUR LA TOXICITE ET L’EFFICACITE THERAPEUTIQUE DANS LES ADENOCARCINOMES PANCREATIQUES RESEQUES

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Capability of CDA to predict occurence of severe toxicities

Primary: Capability of CDA to predict occurence of severe toxicities

Secondary: Overall Survival

Secondary: Overall Survival

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
PHARMACOGENETIQUE DE LA GEMCITABINE : ETUDE DE L’IMPACT DU POLYMORPHISME GENETIQUE DE LA CYTIDINE DEAMINASE (CDA) SUR LA TOXICITE ET L’EFFICACITE THERAPEUTIQUE DANS LES ADENOCARCINOMES PANCREATIQUES RESEQUES