Clinical Trials Register

Summary
EudraCT Number:	2006-004024-37
Sponsor's Protocol Code Number:	A6181109
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-02-21
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2006-004024-37

A.3

Full title of the trial

SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER (S-TRAC): A
RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF ADJUVANT SUNITINIB
VS. PLACEBO IN SUBJECTS WITH HIGH RISK RCC

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

A6181109

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	PFIZER
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Sutent
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU73/05268
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sunitinib Malate
D.3.9.1	CAS number	341031-54-7
D.3.9.2	Current sponsor code	SU-0011248
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Sutent
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU73/05268
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sunitinib Malate
D.3.9.1	CAS number	341031-54-7
D.3.9.2	Current sponsor code	SU-0011248
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Adjuvant treatment of subjects with “high risk” Renal Cell Carcinoma (RCC) following
nephrectomy.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10038458
E.1.2	Term	Renal granular cell carcinoma

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate an improvement in disease-free survival (DFS) in high risk (per modified
UISS criteria) subjects with RCC randomly assigned to adjuvant sunitinib 50 mg schedule
4/2: 4 weeks on, 2 weeks off for 1 year (Arm A), vs. Placebo (Arm B) after nephrectomy.

E.2.2

Secondary objectives of the trial

Compare overall survival (OS) associated with Arm A to that associated with Arm B
Assess safety/toxicity profile of schedule 4/2: 4 weeks on, 2 weeks off administration of
sunitinib
Assess patient reported outcomes (PROs)
Assess the UISS Prognostic Model

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

FARMACOGENETICA

E.3

Principal inclusion criteria

1.Subjects must sign and date IRB/IEC-approved informed consent
2. Age >/= 18 years
3. ECOG Performance Status 0 – 2 prior to nephrectomy
4. Subjects must be diagnosed in the high risk UISS staging system with one of the
following:
a. T3 N0 or Nx, M0, Fuhrman’s grade >/= 2 and ECOG general status >/= 1, or
b. T4 N0 or Nx, M0, any Fuhrman’s grade and any ECOG general status, or
c. Any T, N1-2, M0, any Fuhrman’s grade and any ECOG general status
3.
5. Subjects must have histologically confirmed preponderant clear cell RCC
6. Subjects must have no evidence of macroscopic residual disease or metastatic disease
Subjects having evidence for microscopic disease (R1) are acceptable
7. Subjects must not have received any specific medical previous systemic treatment for
RCC
8. Subjects must not have received any previous anti-angiogenic treatment
9. Subjects must receive the first oral dose of sunitinib not more than 10 weeks after
date of nephrectomy (see Appendix 6 for Nephrectomy Procedure).
10. Subjects must have adequate organ function defined as:a. Platelets >/= 100 x 10(9)/L, hemoglobin >/= 8 g/dl, absolute neutrophil count (ANC)
>/=1.5 x 10(9)/L;
b. Bilirubin </= 3 mg/dL, aspartate transaminase (AST) and alanine transaminase
(ALT) </= 2.5 times the upper limit of normal
c. International Normalize Ratio (INR) </= 1.7 or Prothrombin time (PT) </=6 sec over `
d. Calculated creatinine clearance >/= 30 ml/min.
11. Sufficient left ventricular ejection function (LVEF) defined as >/=50% 3 to 10 weeks
after date of nephrectomy based on 2-D echocardiogram (ECHO) or multigated
acquisition MUGA
12. Women and men must use adequate contraception during the study. Acceptable
contraception includes implants, injectables, combined oral contraceptives, effective
intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner or
vasectomy. 13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.

E.4

Principal exclusion criteria

1. Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma,
sarcoma or subjects with metastatic renal sites.
2. NCI CTCAE grade 3 hemorrhage <4 weeks of date of randomization.
3. Diagnosis of any second malignancy within the 5 years from date of randomization,
except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for
12 months.
4.Any of the following within the 12 months prior to study drug administration:
severe/unstable angina, myocardial infarction, coronary artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident, including transient
ischemic attack, or pulmonary embolism.
5. Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or
dosing before 7 and 12 days before date of randomization (e.g., ketoconazole,
rifampin, etc. respectively).
6. Ongoing cardiac dysrhythmias of NCI CTCAE grade >/= 2, atrial fibrillation of any
grade, or prolongation of the QTc interval to > 500 msec.
7.Hypertension that cannot be controlled by medications.
8.Treatment with anticoagulant agents and treatment with therapeutic doses of warfarin
currently or within 2 weeks prior to first day of sunitinib administration. Low dose
warfarin for deep vein thrombosis (DVT) prophylaxis is permitted (up to 2 mg/day).
Low molecular weight heparin or aspirin are allowed.
9.Inability to swallow oral medications, or presence of active inflammatory bowel
disease, partial or complete bowel obstruction or chronic diarrhea.
10. Known human immunodeficiency virus (HIV) or acquired immunodeficiency
syndrome (AIDS)-related illness.
11.Known active hepatitis.
12.Pregnancy or breastfeeding. All female subjects with reproductive potential must
have a negative pregnancy test (serum or urine) within the 7 days prior to date of randomization.
13.Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and in
the judgment of the investigator would make the subject inappropriate for entry into this study.
14.Receipt of any investigational oncology or, approved or investigational antiangiogenic
agent prior to study entry.
15.Current treatment on another therapeutic clinical trial. Supportive care trials or nontreatment
trials, e.g. PRO methods studies, are allowed.

E.5 End points

E.5.1

Primary end point(s)

Disease Free Survival: (DFS), defined as the time interval from the date of randomization to
the first date of recurrence or occurrence of a secondary malignancy or death. The primary
DFS analysis will be based on independent blinded 3rd party review. A secondary analysis of
DFS will be based on the local investigator assessment.
Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. The date of
recurrence or occurrence of a secondary malignancy is defined as the date of the independent
blinded 3rd party review confirms recurrence or occurrence of a secondary malignancy for the
first time.
For subjects receiving further anti-tumor therapy before disease recurrence or occurrence of a
secondary malignancy or death, the subjects will be assigned with DFS events at the first date
of recurrence or occurrence of secondary malignancy or death. In the absence of DFS event,
DFS time will be censored at the date of last disease assessment or cutoff date, whichever
come first. Subjects alive who do not have post baseline disease assessment will have their
DFS times censored at Day 1.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-02-21.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	20
F.4.2	For a multinational trial
F.4.2.1	In the EEA	205
F.4.2.2	In the whole clinical trial	275

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2007-12-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-08-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-09-07

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials