Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
2 October 2017 |
Main ID: |
EUCTR2011-002008-33-AT |
Date of registration:
|
11/12/2012 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A Phase I/II Study of Sunitinib in Young Patients with Advanced Gastrointestinal Stromal Tumor
|
Scientific title:
|
A PHASE I/II STUDY OF SUNITINIB IN YOUNG PATIENTS
WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR
|
Date of first enrolment:
|
01/03/2013 |
Target sample size:
|
30 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002008-33 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
|
Phase:
|
Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
|
|
Countries of recruitment
|
Argentina
|
Austria
|
Brazil
|
Canada
|
Chile
|
Czech Republic
|
Egypt
|
France
|
Germany
|
Hungary
|
India
|
Italy
|
Jordan
|
Mexico
|
Norway
|
Poland
|
Portugal
|
Singapore
|
Slovakia
|
Spain
|
Turkey
|
United Kingdom
|
United States
| |
Contacts
|
Name:
|
Clincal Trials.gov Call Center
|
Address:
|
235 East 42nd Street
NY 10017
New York
United States |
Telephone:
|
001800718 1021 |
Email:
|
ClinicalTrials.gov_Inquiries@pfizer.com |
Affiliation:
|
Pfizer Inc. |
|
Name:
|
Clincal Trials.gov Call Center
|
Address:
|
235 East 42nd Street
NY 10017
New York
United States |
Telephone:
|
001800718 1021 |
Email:
|
ClinicalTrials.gov_Inquiries@pfizer.com |
Affiliation:
|
Pfizer Inc. |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible to commence study drug treatment into the study:
1. Histological diagnosis of GIST (refer to Section 6.1 of the protocol);
2. Tumor tissue must be available to assess KIT, PDGFRA, and BRAF genotypes (for any of these genes where genotyping was not previously performed) and to assess succinate dehydrogenase (SDH) protein expression by immunohistochemistry. For exceptions see Section 6.1 of the protocol;
3. Patients must have demonstrated disease progression or intolerance to imatinib mesylate; have GIST with non-mutant KIT (tumor genotyping may be performed prior to or during screening; patients with an indeterminate KIT genotype are eligible if genotyping performed during screening); or cannot obtain imatinib in their country.
4. Age 6 to <21 years;
5. Advanced, unresectable GIST for which there are no available options for treatment with curative intent as assessed by the investigator;
6. Measurable (per Response Evaluation Criteria in Solid Tumors; RECIST version 1.1; or evaluable disease (Refer to Appendix 4 of the protocol);
7. Resolution of all acute toxic effects of prior cancer treatment, radiotherapy or surgical procedure to NCI CTCAE v4.0 grade =1;
8. ECOG Performance Status 0 2 (for patients =11 years of age) or Lansky =50% (for patients <11 years);
9. Adequate organ function determined within 14 days prior to enrollment, defined by:
• Peripheral absolute neutrophil count (ANC) =1500/µL;
• Platelet count =100,000/µL;
• Hemoglobin =10 g/dL;
• Total bilirubin =1.5 x upper limit of normal (ULN) for age;
• ALT (SGPT) or AST (SGOT) = 3 x ULN for age;
• Serum albumin =2.0 g/dL;
• Serum amylase and lipase <1.5 x ULN;
• Serum creatinine based on age/gender
• Blood Pressure (BP) < the 95th percentile for age, height and gender (refer to Appendix 3 of the protocol for pediatric ranges);
• Cardiac shortening fraction or ejection fraction greater than the lower limit of normal (LLN).
10. Evidence of a personally signed and dated informed consent (and where applicable, assent) document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study;
11. Patients (including legal guardian for minors where applicable) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including anticipated ability to swallow capsules;
12. Male and female patients of childbearing potential who are sexually active must agree to use a highly effective method of contraception throughout the study and for 30 days after the last sunitinib treatment. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active (refer to section 4.3 of the protocol). Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria: Patients presenting with any of the following will not be included in the study:
1. Current treatment with another investigational agent and/or systemic anti-cancer therapy within 4 weeks before starting sunitinib treatment;
2. Prior sunitinib treatment;
3. Prior therapy with known risk for cardiovascular complications, eg, high intensity anthracycline therapy (ie, total equivalent cumulative dose > 100 mg/m2 of doxorubicin) or prior radiation therapy that included the heart (cardiac silhouette) and/or craniospinal radiation;
4. Concomitant treatment with any drug having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide);
5. Prior diagnosis of cardiac disease, including, but not limited to:
• Ongoing cardiac dysrhythmias of NCI CTCAE v4.0 = grade 2, atrial fibrillation of any grade;
• QTc interval >450 msec for males or >470 msec for females;
• Hypertension that cannot be controlled by medications;
• Any of the following within the 12 months prior to starting study treatment: congestive heart failure, cerebrovascular accident including transient ischemic attack or pulmonary embolism.
6. Grade =3 hemorrhage within 4 weeks prior to study entry;
7. Current treatment with therapeutic doses of coumarin derivative anticoagulants such as warfarin or anti vitamin K agents;
8. Concurrent administration of strong cytochrome P450 3A (CYP3A4) inhibitor(s) and/or inducer(s) within 7 and 12 days prior to first dose of study drug, respectively (see Section 5.5.2 of the protocol);
9. Prior radiation to >25% of the bone marrow.
10. Patients with history of allergic reaction attributed to any component of sunitinib capsules;
11. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for 30 days after last dose of investigational product; in the UK, males and females of childbearing potential not using two (2) methods of highly effective
contraception or not agreeing to continue two (2) methods of highly effective contraception for 30 days after last dose of investigational product;
12. Active infection with HIV, or receiving antiretroviral therapy for HIV disease;
13. Patients who are investigational site staff members or relatives of those site staff members or patients who are Pfizer employees directly involved in the conduct of the trial;
14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Pediatric Gastro Intestinal Stromal Tumor (GIST) MedDRA version: 14.1
Level: LLT
Classification code 10062427
Term: Gastrointestinal stromal tumor
System Organ Class: 100000004864
|
Therapeutic area: Diseases [C] - Cancer [C04]
|
Intervention(s)
|
Trade Name: Sutent Pharmaceutical Form: Capsule INN or Proposed INN: Sunitinib malate CAS Number: 341031-54-7 Current Sponsor code: SU011248 Other descriptive name: SU011248 L-Malate; SU010398; PHA-290940AD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
Trade Name: Sutent Pharmaceutical Form: Capsule INN or Proposed INN: Sunitinib malate CAS Number: 341031-54-7 Current Sponsor code: SU011248 Other descriptive name: SU011248 L-Malate; SU010398; PHA-290940AD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5-
Product Name: Sutent Pharmaceutical Form: Capsule INN or Proposed INN: Sunitinib malate CAS Number: 341031-54-7 Current Sponsor code: SU011248 Other descriptive name: SU011248 L-Malate; SU010398; PHA-290940AD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6.25-
|
Primary Outcome(s)
|
Timepoint(s) of evaluation of this end point: Descriptive statistics for observed and dose-corrected (where appropriate) PK data will be reported for all patients with at least one PK observation by presenting the population size, arithmetic mean, standard deviation, percent coefficient of variation (CV%), median, minimum, maximum values at the end of the study.
|
Secondary Objective: • To investigate whether doses greater than the established pediatric MTD are tolerated in pediatric patients with GIST; • To investigate the safety and tolerability of sunitinib in children and young adults with GIST; • To investigate the anti tumor activity of sunitinib in children and young adults with GIST; • To explore PK pharmacodynamic relationships with respect to safety and efficacy in children and young adults with GIST.
|
Main Objective: To characterize the plasma PK profile of sunitinib and its active metabolite SU012662 in children and young adults with advanced GIST.
|
Primary end point(s): Pharmacokinetic parameters of sunitinib and its main active metabolite (SU012662) including total plasma exposure (AUC24) and oral clearance (CL/F).
|
Secondary Outcome(s)
|
Secondary end point(s): • Type, incidence, severity (graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0 [v4.0]), timing, seriousness, and relatedness of adverse events and laboratory abnormalities;
• Objective response rate, duration of response, PFS and OS at 2 years after study enrollment;
• Pharmacokinetic pharmacodynamic relationships with respect to safety and efficacy in pediatric GIST
|
Timepoint(s) of evaluation of this end point: At the end of the study.
|
Secondary ID(s)
|
2011-002008-33-HU
|
A6181196
|
Source(s) of Monetary Support
|
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|