Phase 3 open-label study of tivozanib versus sorafenib in refractory renal cell carcinoma

Phase 1

• Conditions: Advanced Renal Cell Carcinoma; MedDRA version: 18.1Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003607-30-ES
• Lead Sponsor: AVEO PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-13
• Study Completion: 2021-06-21
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. >/= 18-years of age.
2. Subjects with recurrent metastatic RCC who have failed 2 or 3 prior systemic regimens, one of which includes a VEGFR TKI other than sorafenib or tivozanib.
3. Subjects must have recovered from the AEs of prior therapy or returned to baseline, and be off all therapy for at least 2 weeks.
4. Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, mixed tumor containing predominantly sarcomatoid cells, and unclassified RCC are excluded).
5. Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Life expectancy ? 3 months.
8. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment.
9. Ability to give written informed consent and comply with protocol.
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 161
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 161

Exclusion Criteria

1. Prior treatment with sorafenib or tivozanib.
2. More than 3 prior regimens for metastatic RCC.
3. Known central nervous system (CNS) diseases other than stable, treated brain metastases, defined as primary CNS malignancies or CNS metastases
4. Significant cardiovascular disease
5. Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
6. Significant bleeding disorders
7. Currently active second primary malignancy
8. Pregnant or lactating females.

Participation in another interventional protocol.

Study & Design

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