Clinical Trials Register

Summary
EudraCT Number:	2006-004024-37
Sponsor's Protocol Code Number:	A6181109
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-06-11
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

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

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 AT HIGH RISK OF RECURRENT RCC

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Phase 3 study of sunitinib versus placebo in subjects at high risk of recurrent kindey cancer

A.3.2

Name or abbreviated title of the trial where available

S-TRAC

A.4.1

Sponsor's protocol code number

A6181109

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc. 235 East 42nd Street, New York, 10017 US
B.1.3.4	Country	United States
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	Pfizer Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Callcenter
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	0018007181021
B.5.5	Fax number	0013037391119
B.5.6	E-mail	ClinicalTrials.govCallCenter@pfizer.com

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	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Sutent
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	No
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	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Sutent
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	No

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.

E.1.1.1

Medical condition in easily understood language

Adjuvant treatment of subjects with high risk of recurrent renal cell carcinoma after nephrectomy

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	11.0
E.1.2	Level	HLT
E.1.2	Classification code	10038408
E.1.2	Term	Renal cell carcinomas
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate an improvement in disease free survival (DFS) in subjects at the highest (per modified UISS criteria) risk of disease recurrence with RCC randomly assigned to adjuvant sunitinib 50 mg schedule 4/2 for 1 year (9 cycles) (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 administration of sunitinib;
•Assess patient reported outcomes (PROs);
•Assess the UISS Prognostic Model

E.2.3

Trial contains a sub-study

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 utilizing the UISS staging system with one of the following:
a.T3 N0 or Nx, M0, any Fuhrman’s grade and any ECOG general status; 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.
5.Subjects must have histologically confirmed preponderant, defined as >50%, clear cell RCC;
6.Subjects must have no evidence of macroscopic residual disease or metastatic disease. Subjects having evidenceof microscopic disease (Histological classification of R1 disease) are acceptable;
7.Subjects must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) 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 12 weeks after date of nephrectomy
10.Subjects must have adequate organ function defined as:
a.Platelets ≥75 x 109/L, hemoglobin ≥ 8 g/dl, absolute neutrophil count (ANC) ≥1.5 x 109/L;
b.Bilirubin ≤3 mg/dL (known Gilbert’s exempt from this criteria), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN);
c.Calculated creatinine clearance ≥30 ml/min post-nephrectomy as determined by the Cockcroft and Gault Equation (listed in the Q&A document posted to the Insight space for all PCO managers);
11.Women and men must use adequate contraception during the study. Acceptable contraception for women include implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for a male includes having had a vasectomy for at least 6 months, sexual abstinence, or condoms plus spermicide;
12.UK and IRELAND ONLY. Women and men must use adequate contraception during the study. Adequate contraception is defined as double barrier contraception (ie, condom plus spermicide in combination with a female condom, diaphragm, cervical cap or intrauterine device).
13.Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO);
14.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, sarcomas, collecting duct carcinoma, lymphoma, or subjects with any 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 6 months prior to study drug administration: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism;
5.Concurrent medication with known CYP3A4 inducers and potent inhibitors dosed 7 and 12 days before date of randomization, respectively
6.Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2 or prolongation of the QTc interval to >500 msec;
7.Hypertension, defined as systolic >150 and/or diastolic >100, that cannot be controlled by medications;
8.Treatment with >2 mg of warfarin within 2 weeks prior to first day or concurrently with sunitinib administration is not recommended. Low dose warfarin for deep vein thrombosis (DVT) prophylaxis is permitted (<2 mg/day). Low molecular weight heparin (fractionated) or aspirin are allowed;
9.Any illness that may affect absorption, including but not limited to: inability to swallow oral medications, presence of active inflammatory bowel disease, partial or complete bowel obstruction, partial or complete gastrectomy, significant bowel resection, or chronic diarrhea;
10.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness;
11.Known active or chronic active hepatitis (Hepatitis B or C);
12. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outline in the protocol for the duration of the study and for at least 28 days after the last dose of investigational product;
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 anti angiogenic agent prior to study entry;
15.Current treatment on another therapeutic clinical trial. Supportive care trials or non treatment trials, eg, PRO methods studies, are allowed.
16. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

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 the occurrence of a secondary malignancy or death. The primary DFS analysis will be based on independent blinded third-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 the occurrence of a secondary malignancy is defined as the date of the tumor assessment that demonstrated unequivocal recurrence or a second malignancy according to protocol criteria and is confirmed by independent, blinded third party review. For subjects with no DFS event, DFS time will be censored at the date of last disease assessment prior to the time of the final analysis. Subjects alive who do not have post baseline disease assessment will have their DFS times censored at randomisation. For subjects receiving further anti tumor therapy prior to disease recurrence or occurrence of a secondary malignancy or death, DFS will be censored on the date of the last tumor assessment prior to taking the anti tumor medication.

E.5.1.1

Timepoint(s) of evaluation of this end point

Disease Free Survival: (DFS), time interval from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. For subjects with no DFS event, DFS time censored at date of last disease assessment prior to time for final analysis. Subjects alive who do not have post baseline disease assessment will have their DFS times censored at randomization. For subjects receiving further anti tumor therapy prior to disease recurrence or occurrence of a secondary malignancy or death, DFS will be censored on the date of the last tumor assessment prior to taking the anti tumor medication.

E.5.2

Secondary end point(s)

• Overall Survival (OS), defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive. Subjects lacking data beyond randomization will have their survival times censored at randomization.
• Type, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 3.0 dated 09 August 2006), seriousness, and relatedness of adverse events, and laboratory abnormalities;
• Patient reported outcomes (PROs), defined as health related quality of life using the self administered European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (EORTC QLQ-C30) and health status using the EuroQoL Group EQ-5D questionnaire (EQ-5D). The questionnaires will be completed on Day 1 or approximately every 6 weeks, prior to having any tests or receiving any treatment up to the end of study treatment with sunitinib or placebo.

E.5.2.1

Timepoint(s) of evaluation of this end point

1- Overall Survival (OS) time from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time will be censored at last date the subject is known alive. Subjects lacking data beyond randomization will have their survival times censored at randomization. 2- Type, incidence, severity (graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, timing, seriousness, and relatedness of adverse events and laboratory abnormalitiesonship. 3- Patient reported outcomes (PROs), at end of study

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

Yes

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

Yes

E.6.13.1

Other scope of the trial description

QoL

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

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.8.2.4

Number of treatment arms in the trial

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.8.5.1

Number of sites anticipated in the EEA

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

Australia

Austria

Canada

China

Colombia

Czech Republic

Denmark

France

Germany

Greece

Ireland

Israel

Italy

Korea, Republic of

Malaysia

Mexico

Poland

Slovakia

Spain

Sweden

Switzerland

Taiwan

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

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

End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application (ie, Clinical Trial Application (CTA)) and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the trial in that Member State

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

427

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

192

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

450

F.4.2.2

In the whole clinical trial

619

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Please refer to section 6.2 of the Protocol.

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

2007-06-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-08-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-08-30

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