Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.

• Status: Completed
• Trial end date: 2020-06-19
• Target enrollment: 0
• Participant gender: All

Summary

Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Nintedanib; Sunitinib

Criteria

Inclusion criteria:

1. Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment.

2. Histological-confirmed diagnosis of renal cell cancer with clear cell component.

3. Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow sunitinib/BIBF 1120 treatment.

Exclusion criteria:

1. Patients unable to tolerate Sunitinib/BIBF 1120 treatment

2. Treatment with other investigational drugs or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study.

3. Patients unable to comply with the 1199.26 protocol.

4. Pregnancy or breast feeding.

5. Active alcohol or drug abuse.

6. Women of child bearing potential, or men who are able to father a child, unwilling to use a medically acceptable form of contraception during the study period.