NCT02835833

Study of Nintedanib Plus Bevacizumab in Advanced Solid Tumors

Phase I Dose Escalation Study of Nintedanib Plus Bevacizumab in Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Angiogenesis, the development of new blood vessels, plays an important role in the disease development and tumor growth in many solid organ malignancies. Bevacizumab was the first anti-angiogenic drug to be approved in solid tumors and has shown advantageous activity with multiple tumor types. However, the responses from Bevacizumab are often transient due to the tumor's manipulative abilities to circumvent the usual pathways to find salvage pathways instead. Nintedanib has demonstrated anti-tumor activity in non-squamous non-small cell lung cancer, colorectal cancer, ovarian cancer, and renal cell cancer. The combination of Bevacizumab and Nintedanib are being proposed to target the tumor's manipulation processes to generate alternate pathways for angiogenesis thus creating a potential benefit to delay tumor growth.

Detailed description

This is an open-label, phase I dose-escalation study of Nintedanib combined with standard-dose Bevacizumab for advanced solid tumors in which Bevacizumab has an indication. The primary endpoints will be safety and tolerability of the drug combination and a determination of recommended Phase II dose for Nintedanib in combination with standard dose Bevacizumab. The first three patients will be treated with Nintedanib daily plus Bevacizumab on day one of each three week cycle. If there are no dose limiting toxicities, then three additional patients will be treated with the same drugs with Nintedanib at a slightly higher level. Finally, a third cohort of three patients will be dosed at an even higher level. Once the maximum tolerated dose of Nintedanib is reached, then an additional six patients will be treated at that dose in combination with Bevacizumab until disease progression or unacceptable toxicities.

Conditions

• Renal Cell Carcinoma
• Colorectal Adenocarcinoma
• Non-squamous Non-small Cell Lung Cancer
• Platinum-refractory Ovarian Carcinoma
• Cervical Carcinoma

Interventions

Type	Name	Description
DRUG	Nintedanib	Nintedanib will be given twice daily at either 150 mg or 200 mg.
DRUG	Bevacizumab	Bevacizumab will be given at 15 mg/kg

Timeline

• Start date: 2016-06-09
• Primary completion: 2018-04-14
• Completion: 2018-06-14
• First posted: 2016-07-18
• Last updated: 2018-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study