NCT02824575

Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Metastatic Breast Cancer

Phase Ib Study of Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Patients With Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of rebastinib when combined with antitubulin therapy with paclitaxel or eribulin in patients with advanced breast cancer.

Detailed description

Metastasis is the primary cause of death from breast cancer, invasive carcinoma cells in mouse and rat mammary tumors co-migrate accompanied by macrophages towards intravasation sites . The intravasation occurs at sites where a TIE2-expressing macrophage, a mena-expressing tumor cell, and an endothelial cell are in direct contact, forming a micro-anatomic structure called tumor micro-environment of metastasis (TMEM). Ablation of the presence or activity of the TMEM associated macrophages blocks intravasation at TMEM demonstrating an essential role of perivascular macrophages in TMEM function. Rebastinib, a TIE2 inhibitor , blocks TMEM assembly and function in-vivo and in-vitro assays. We hypothesize that rebastinib combined with antitubulin therapy (eribulin or paclitaxel) could improve clinical outcomes in breast cancer by preventing intravasation at TMEM sites and preventing further metastasis.

Conditions

• Breast Cancer
• Breast Adenocarcinoma
• Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
• Recurrent Breast Carcinoma
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	Rebastinib	50 mg or 100 mg po BID continuously. Cycle duration: 21 days. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
DRUG	Paclitaxel	Paclitaxel 80 mg/m2 weekly. Cycle duration = 21 days. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
DRUG	Eribulin Mesylate	Eribulin 1.4 mg/m2 day 1 \& 8. Cycle duration : 21 days. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.

Timeline

• Start date: 2016-07-01
• Primary completion: 2021-12-27
• Completion: 2021-12-27
• First posted: 2016-07-06
• Last updated: 2022-04-04

Locations

1 site across 1 country: United States