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

Phase 1

• Conditions: Advanced Renal Cell Carcinoma; MedDRA version: 21.1Level: 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-GB
• Lead Sponsor: AVEO PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-08
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. = 18-years of age.
2. Subjects with 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. Controlled AEs such as hypothyroidism or hypertension are permitted.
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 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 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175

Exclusion Criteria

1. Prior treatment with sorafenib or tivozanib.
2. More than 3 prior regimens for metastatic RCC.
3. Known central nervous system (CNS) metastases other than stable, treated brain metastases. Subjects with previously treated brain metastasis will be allowed if the brain metastasis has been stable by neuroimaging without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
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.
9. Participation in another interventional protocol.

Study & Design

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