Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Carcinoma

Breast Neoplasms

Adenocarcinoma

Neoplasm Metastasis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Rebastinib

Tubulin Modulators

Antimitotic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

* Arm A1 (Dose Escalation Cohort): Paclitaxel 80 mg/m2 weekly x 12 weeks plus Rebastinib (50 mg PO BID or 100 mg PO BID) beginning on cycle 1, day 1 and given continuously.
* Arm A2 (Expansion Cohort): Paclitaxel 80 mg/m2 weekly x 12 weeks. Patients will be randomized to receive Rebastinib (at RP2D) beginning on cycle 1, day 1 OR cycle 2, day 1.

* Arm B1 (Dose Escalation Cohort): Eribulin Mesylate 1.4 mg/m2 day 1 \& 8 q21 days plus Rebastinib (50 mg PO BID or 100 mg PO BID) beginning on cycle 1, day 1 and given continuously.
* Arm B2 (Expansion Cohort): Eribulin Mesylate 1.4 mg/m2 day 1 \& 8 q21 days. Patients will be randomized to receive Rebastinib (at RP2D) beginning on cycle 1, day 1 OR cycle 2, day 1.

50 mg or 100 mg po BID continuously. Cycle duration: 21 days. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.

Paclitaxel 80 mg/m2 weekly. Cycle duration = 21 days. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.

Eribulin 1.4 mg/m2 day 1 \& 8. Cycle duration : 21 days. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.

Eribulin Mesylate

Jesus D Anampa Mesias, M.D

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.

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.

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

Arm A: To determine the recommended phase II dose (Arm A1 - dose escalation cohort) and overall safety profile (Arm A2 - expansion cohort) of Rebastinib (50 mg PO BID or 100 mg PO BID) given concurrently with weekly paclitaxel (80 mg/m2 weekly x 12 ) over 3 consecutive weeks (1 cycle) in patients with metastatic breast cancer.

Arm B: To determine the recommended phase II dose (Arm B1 - dose escalation cohort) and overall safety profile (Arm B2 - expansion cohort) of Rebastinib (50 mg PO BID or 100 mg PO BID) given concurrently with weekly eribulin (1.4 mg/m2 days 1 and 8 every 21 days) over 3 consecutive weeks (1 cycle) in patients with metastatic breast cancer.

Arm A1-2 and Arm B1-2 (evaluate separately for each arm): To determine the progression-free survival of patients treated with Rebastinib plus paclitaxel, and Rebastinib plus eribulin (at all Rebastinib dose levels).

Arm A1-2 and Arm B1-2 (evaluate separately for each arm): To determine overall survival of patients treated with Rebastinib plus paclitaxel, and Rebastinib plus eribulin (at all Rebastinib dose levels).

Arm A1-2 and Arm B1-2 (evaluate separately for each arm): To determine clinical benefit rate of patients treated with Rebastinib plus paclitaxel, and Rebastinib plus eribulin (at all Rebastinib dose levels).

Arm A1-2 plus Arm B1-2 (evaluate combined dataset including both arms): To determine correlation between Rebastinib and angiopoietin (ANG1 and/or ANG2) levels (a surrogate marker for TIE2 inhibition)

Arm A2 plus Arm B2: To perform an exploratory analysis of the effects of Rebastinib plus antitubulin therapy on circulating tumor cell (CTCs) during cycle 1, by comparing CTCs during cycle 1 in patients randomized to receive or not rebastinib during cycle 1.

Arm A2 plus Arm B2: To perform an exploratory analysis of the effects of Rebastinib plus antitubulin therapy on TIE-2 expressing monocytes (TEM) during cycle 1.

Arm A2 or Arm B2: To perform an exploratory analysis of the effects of Rebastinib plus antitubulin therapy on TMEM score and TMEM function in a cohort of up to 6 patients with metastatic cancer who have their primary tumor in place and are agreeable to up to 2 research biopsies of the primary tumor before and during (i.e., after 3 weeks of) Rebastinib therapy.

Deciphera Pharmaceuticals LLC

Albert Einstein College of Medicine

Montefiore Medical Center

Assistant Professor of Medicine

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinosarcoma

Mixed Tumor, Mullerian

Ovarian Cancer

Ovarian Epithelial Cancer

Malignant Mixed Mullerian Tumor

Dose comparison between 50 or 100 mg BID of rebastinib orally (PO) in combination with paclitaxel administered by IV infusion at 80 mg/m2 in repeated 28-day cycles.

Dose expansion in the following tumor types at the recommended Phase 2 dose (RP2D) of rebastinib in combination with paclitaxel

* Triple-negative and Stage IV inflammatory breast cancer
* Ovarian cancer
* Endometrial cancer
* Gynecological Carcinosarcoma

rebastinib

Paclitaxel administered by IV infusion at 80 mg/m2

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.

A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors

Measure of the time from Cycle 1 Day 1 to disease progression or death due to any cause

Measure of the time from Cycle 1 Day 1 to the first documentation of progressive disease

Measure of time from PR, CR to disease progression or death due to any cause

Respiratory Tract (Lung and Bronchial) Diseases

Mesothelioma

Mesothelioma, Malignant

Malignant Mesothelioma

Carboplatin

Dose comparison between 50 or 100 mg BID of rebastinib orally (PO) dosed in 21-day cycles in combination with carboplatin administered by IV infusion at either AUC5 or AUC6 once every 3 weeks

Dose expansion in the following tumor types at the recommended Phase 2 dose (RP2D) of rebastinib in combination with carboplatin

* Triple-negative breast cancer
* Platinum-sensitive Ovarian cancer
* Mesothelioma

Carboplatin administered by IV infusion at AUC5 or AUC6

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.

A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors

An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors

Measure of time from first PR, CR to disease progression or death due to any cause

Measure of the interval between Cycle 1 Day 1 until date of death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Metastatic Breast Cancer	NCT02824575	Breast Cancer Breast Adenocar... Human Epidermal... Recurrent Breas... Stage IV Breast...	Rebastinib Paclitaxel Eribulin Mesyla...	18 Years -	Montefiore Medical Center
Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Metastatic Breast Cancer	NCT02824575	Breast Cancer Breast Adenocar... Human Epidermal... Recurrent Breas... Stage IV Breast...	Rebastinib Paclitaxel Eribulin Mesyla...	18 Years -	Montefiore Medical Center
A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors	NCT03601897	Locally Advance...	rebastinib Paclitaxel	18 Years -	Deciphera Pharmaceuticals LLC
A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors	NCT03717415	Locally Advance...	rebastinib Carboplatin	18 Years -	Deciphera Pharmaceuticals LLC
A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors	NCT03601897	Locally Advance...	rebastinib Paclitaxel	18 Years -	Deciphera Pharmaceuticals LLC

Spots Global Cancer Trial Database for rebastinib

Every month we try and update this database with for rebastinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rebastinib

Every month we try and update this database with for rebastinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rebastinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.