Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Disease Progression

Breast Diseases

Skin Diseases

Disease Attributes

Herbal and Botanical

All Drugs and Chemicals

This is a single arm study comparing changes within patients before and after receiving the experimental drug Polyphenon E for the duration of the study, between recruitment and surgery for breast cancer.

Four 200mg capsules daily taken with a meal, for the duration of the study.

Polyphenon E

Gary Burton, M.D.

To see if an extract of green tea can affect certain markers of breast cancer and breast cancer progression in women with a recent biopsy positive for cancer and who are scheduled for surgery.

To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between breast biopsy and surgery in women with recently diagnosed breast cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.

The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.

1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with breast cancer

1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with breast cancer

1.3 Determine the effects of Polyphenon E on MAPK activation in patients with breast cancer

1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with breast cancer

1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with breast cancer

1.6 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) and Hepatocyte Growth Factor HGF

1.7 Evaluate the safety and tolerability of Polyphenon E in this subject population

A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression

Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression

Change in serum VEGF from baseline to post treatment with polyphenon E.

Change in serum HGF from baseline to post Polyphenol E treatment.

Columbia University

Louisiana State University Health Sciences Center Shreveport

Professor

Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.

ECGC and Breast Cancer

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Jerry w. McLarty, Ph.D.

The null hypothesis is that there is no change, i.e. median change=0.0.

Number of participants for analysis was determined per protocol.

Change in Serum VEGF in Breast Cancer

The effect of ECGC extract on biomarkers in breast cancer.

Change in Serum HGF and Breast Cancer

Overall Study

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Bortezomib

Dexamethasone acetate

Single arm study of MP0250 plus bortezomib + dexamethasone

6 mg/kg or 8 mg/kg or 12 mg/kg of MP0250, IV (in the vein,) on day 1 of each 21 day cycle. Bortezomib and Dexamethasone according to label.

Number of Cycles: until progression or unacceptable toxicity develops.

MP0250 plus BOR+DEX

The purpose of this study is to assess the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and efficacy of MP0250 in combination with bortezomib + dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM).

MP0250 is a multi-DARPin® drug candidate with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.

A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple Myeloma

A Phase 2 Open-label, Single-arm, Multicenter Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma

Defined as the number of participants achieving a complete response (CR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 1.

Defined as the number of participants achieving a confirmed, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 2.

DOR is defined as the duration from first observation of partial response (PR) or better until disease progression, or death from myeloma.

PFS is determined as the time from first study treatment until progression or death from myeloma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression	NCT00676793	Breast Cancer	Polyphenon E	21 Years - 75 Years	Louisiana State University Health Sciences Center Shreveport
A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple Myeloma	NCT03136653	Multiple Myelom...	MP0250 plus BOR...	18 Years -	Molecular Partners AG

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Spots Global Cancer Trial Database for hgf

Every month we try and update this database with for hgf 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 hgf 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.