metastatic renal cell carcinoma MedDRA version: 15.0 Level: LLT Classification code 10038400 Term: Renal carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 15.0 Level: LLT Classification code 10038399 Term: Renal carcinoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 15.0 Level: LLT Classification code 10050076 Term: Metastatic rena
Conditions
Interventions
Product Name: Tivozanib hydrochloride
Product Code: AV-951
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: tivozanib hydrochloride
CAS Number: 682745-41-1
Current Sponsor code: AV-951
Other de
Sponsors
AVEO PHARMACEUTICALS, INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with unresectable mRCC 2. Histologically or cytologically confirmed RCC of any histology 3. Subjects with or without prior nephrectomy Version 1.1 (see Appendix A). 4. ECOG performance status of 0 or 1 (see Appendix B) 5. Ability to give written informed consent and comply with protocol requirements, including drug treatments and follow-up procedures 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 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: 1.Any prior systemic therapy (including interleukin-2, interferon-alpha, chemotherapy, bevacizumab, nvestigational or licensed drug that targets vascular endothelial growth factor [VEGF] or VEGF receptors/pathway or are mammalian target of rapamycin [mTOR] inhibitors) for treatment of mRCC 2.Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders 3. Significant serum chemistry or urinalysis abnormalities. 4. Significant cardiovascular disease, including: •Symptomatic Left Ventricular Dysfunction or baseline left ventricular ejection fraction (LVEF) of 480 msec using Bazett’s formula. 6. Currently active second primary malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare subject treatment preference of tivozanib versus sunitinib;Secondary Objective: To compare overall safety and tolerability in subjects treated with tivozanib and sunitinib. To assess the frequency of dose modifications in subjects treated with tivozanib and sunitinib. To evaluate the Quality of Life (QoL) (including kidney-specific symptoms and fatigue) in subjects treated with tivozanib and sunitinib.;Primary end point(s): Proportion of subjects who prefer tivozanib hydrochloride or sunitinib;Timepoint(s) of evaluation of this end point: up to 25 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): safety and tolerability during the course of the study;Timepoint(s) of evaluation of this end point: up to 25 weeks | — |
Countries
Belgium, France, Germany, Italy, Spain, United Kingdom, United States
Contacts
Public ContactKristina Johnson
AVEO Pharmaceuticals Inc
Outcome results
None listed