Last reviewed · How we verify

NCT02250118: BEVAP

Intrapleural Bevacizumab After Pleural Drainage in the Context of Breast Cancer

Terminated Phase 1 Last updated 6 November 2017
What this trial tests

Phase 1 trial testing Bevacizumab in Pleural Effusion, Malignant in 1 participant. Terminated before completion.

Timeline
9 December 2014
Primary endpoint
12 April 2017
17 October 2017

Quick facts

Lead sponsorInstitut Curie
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment1
Start date9 December 2014
Primary completion12 April 2017
Estimated completion17 October 2017
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Institut Curie — full company profile →

Who can join

18 and older, any sex, with Pleural Effusion, Malignant or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Metastatic pleural effusion is a common complication of late-stage cancer and reduces the quality of life and survival of patients. The survival of patients with recurrent pleurisy by uncontrolled local or systemic treatment is less than 6 months. It is important to develop specific therapies to improve the quality of life and survival of patients with metastatic pleurisy. Bevacizumab is a monoclonal anti vascular endothelial growth factor (VEGF) which has proven effective in many indications in oncology. Vascular endothelial growth factor (VEGF) is an angiogenic factor which increases endothelial permeability. It plays a central role in many tumors of epithelial origin. In this context, it is legitimate to ask whether an antiangiogenic targeting VEGF may be effective in patients with metastatic pleurisy by decreasing local blood supply and over-permeability. No study has been interested in the intra-pleural pharmacokinetics of monoclonal antibodies and there are no predictive or prognostic biomarkers for metastatic pleural effusions. The investigators believe that intrapleural administration of bevacizumab will reduce the pleural vasculature permeability. It will neutralize VEGF present in pleural fluid and reduce the replenishment of effusion due to its prolonged half-life of 21 days. The investigators therefore propose a phase I study to determine the maximum tolerated dose and the recommended dose for phases II, studying the pharmacokinetics of intrapleural bevacizumab administered by an implantable device after evacuating a symptomatic metastatic pleurisy as part of a mammary carcinoma. The VEGF intrapleural levels and serum will be study and the time until a new puncture. Dyspnea will be evaluated as well as its impact on quality of life.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Anti-vascular endothelial growth factor therapy in breast cancer.
    Kristensen TB, Knutsson ML, Wehland M, Laursen BE, et al · · 2014 · cited 48× · PMID 25514409 · DOI 10.3390/ijms151223024

Verify or expand the search:

Other trials of Bevacizumab

Trials testing the same drug.

Other recruiting trials for Pleural Effusion, Malignant

Currently open trials in the same condition.

Other Institut Curie trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02250118.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing