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Study of Nintedanib Plus Bevacizumab in Advanced Solid Tumors

NCT02835833 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-07-10

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Francisco Robert, MD · University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-09
Primary Completion
2018-04-14
Completion
2018-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835833 on ClinicalTrials.gov