Isoquercetina come terapia di supporto nei pazienti affetti da tumore del rene in trattamento di I linea con sunitinib: uno studio di fase I/II

Phase 1

• Conditions: ocally advanced or metastatic renal cell carcinoma of any histology (equivalent to Stage IV RCC according to AJCC staging); MedDRA version: 19.0Level: PTClassification code 10061482Term: Renal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10038389Term: Renal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10050018Term: Renal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000194-12-IT
• Lead Sponsor: CONSORZIO ONCOTECH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-18
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Received no prior systemic therapy other than sunitinib (including interleukin-2,
interferon-a, chemotherapy, bevacizumab, mTOR inhibitor sorafenib or other VEGF
TKI) for advanced or metastatic RCC. Patients who received adjuvant treatment with
a cancer vaccine are eligible;
2. Patients with locally advanced (defined as disease not amenable to curative surgery or
radiation therapy) or metastatic renal cell carcinoma of any histology (equivalent to
Stage IV RCC according to AJCC staging) for whom treatment with sunitinib is either
planned or ongoing. Patients with non-measurable disease are allowed if metastatic
disease can be confirmed;
3. Patients for whom treatment with sunitinib is planned must have had a whole body
CT scan within 30 days prior to enrollment; patients who are already being treated
with sunitinib at the time of enrollment must have had a whole body CT scan showing
non progressive disease according to the RECIST criteria with respect to the
assessment performed at sunitinib initiation within 30 days of enrollment;
4. ECOG PS of 0 or 1;
5. Age =18 years;
6. A female is eligible to enter and participate in this study if she is non-childbearing
potential (i.e. physiologically incapable of becoming pregnant).
The need for a screening pregnancy test depends on whether a female subject is of
childbearing potential or non-childbearing potential.
7. A female of non-childbearing potential (i.e., physiologically incapable of becoming
pregnant) is defined as any female who has had a hysterectomy, bilateral ophorectomy
(ovariectomy) or bilateral tubal ligation, or is post-menopausal by NCCN
criteria.Adequate organ system functions;
8. Total serum calcium concentration <12.0mg/dL;
9. Left ventricular ejection fraction (LVEF) = lower limit of institutional normal (LLN)
as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan.
The same modality used at baseline must be applied for subsequent evaluations;
10. Patient is able to swallow and retain oral tablets;
11. Written informed consent obtained before any screening procedure and according to
local guidelines.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

1. History of another malignancy;
2. History or clinical evidence of central nervous system (CNS) metastases;
3. Any clinically significant gastrointestinal abnormalities that may increase the risk for
gastrointestinal bleeding or affect absorption of investigational product;
4. Unable to tolerate continuous daily administration of 50 mg sunitinib
5. Presence of uncontrolled infection;
6. Serum potassium < lower normal limits;
7. Corrected QT interval (QTc) >480 msec using Bazett’s formula;
8. History of one or more of the following cardiovascular conditions within the past 6
months:
? Cardiac angioplasty or stenting;
? Myocardial infarction;
? Unstable angina;
? Coronary artery bypass graft surgery;
? Symptomatic peripheral vascular disease;
? Class III or IV congestive heart failure, as defined by the New York Heart
Association (NYHA);
9. Poorly controlled hypertension (defined as systolic blood pressure (SBP) of >
150mmHg or diastolic blood pressure (DBP) of > 90mmHg) at baseline;
10. History of cerebrovascular accident (CVA) including transient ischemic attack (TIA),
pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6
months;
11. Prior major surgery or trauma within 28 days prior to first dose of study drug and/or
presence of any non-healing wound, fracture, or ulcer (procedures such as catheter
placement not considered to be major);
12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels;
13. Evidence of active bleeding or bleeding diathesis;
14. Significant hemoptysis within 6 weeks prior to first dose of study drug;
15. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that
could interfere with patient’s safety, obtaining informed consent or compliance to the
study;
16. Use any prohibited medications within 14 days of the first dose of study medication;
17. Use of an investigational agent other than sunitinib, including an investigational anticancer
agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose
of study drug;
18. Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose
of study treatment;
19. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to sunitinib;
20. Clinically significant depression (PHQ-9 score >15), anxiety (GAD score >10),
clinically significant insomnia (positivity of ISQ).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified