Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Bafetinib

Protein Kinase Inhibitors

Enzyme Inhibitors

250 mg orally twice daily. Treatment continues until clinically significant disease progression or unacceptable toxicity is documented.

bafetinib

Daniel Levitt, M.D., Ph.D.

A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL).

Bafetinib is a dual protein kinase inhibitor, targeting both bcr/abl and Lyn kinases. B-cell chronic lymphocytic leukemia cells overexpress Lyn kinase compared to normal B lymphocytes as well as acute leukemias (ALL and AML), and inhibition of Lyn kinase induces apoptosis in cultures of B-CLL cells. Thus, bafetinib may stop the growth of B-CLL cells by inhibiting Lyn kinase, the molecule that couples the B cell receptor to downstream signaling.

Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

CytRx

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hormones

This is a Phase II open-label study evaluating the preliminary efficacy and safety of bafetinib administered as 240 mg orally twice daily in subjects with Hormone Refractory Prostate Cancer.

Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer

A Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer

The primary objective of this study is to determine the preliminary efficacy of administration of bafetinib in subjects with hormone-refractory prostate cancer (HRPC), as measured by the objective response rate (ORR), which is a combination of CR (PSA ≤0.12 ng/mL) and PR (≥50% reduction in PSA from baseline).

The safety of bafetinib in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, and vital signs.

Progression-free survival is defined as the time from enrollment to first documentation of objective PSA or tumor progression, or to death due to any cause in the absence of previous documentation of objective tumor progression.

The total proportion of subjects who have an objective tumor reponse (CR + PR) using the RECIST criteria.

Nervous System Diseases

Neoplasm Metastasis

Recurrence

Glioblastoma

Glioma

Brain Neoplasms

Astrocytoma

Ependymoma

Oligodendroglioma

Gliosarcoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Adult

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Oligoastrocytoma

Anaplastic Oligoastrocytoma

Anaplastic Ependymoma

Neuroepithelioma

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Patients undergo intracerebral microdialysis during debulking craniotomy or stereotactic biopsy. Beginning 24 hours later, patients receive oral bafetinib twice daily for 1 day. Beginning at least 2 weeks after surgery, patients continue to receive oral bafetinib twice daily in the absence of disease progression or unacceptable toxicity.

Catheter placed intracerebrally during debulking craniotomy or stereotactic biopsy

microdialysis

pharmacological study

liquid chromatography

mass spectrometry

laboratory biomarker analysis

protein expression analysis

western blotting

immunohistochemistry staining method

therapeutic conventional surgery

Jana Portnow

RATIONALE: Bafetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This clinical trial studies bafetinib in treating patients with recurrent high-grade glioma or brain metastases.

PRIMARY OBJECTIVES:

I. To determine the neuropharmacokinetics (nPK) and systemic levels of bafetinib in patients with recurrent malignant brain tumors.

SECONDARY OBJECTIVES:

I. To investigate the intrapatient variability of nPK parameters as assessed by intracerebral microdialysis.

II. To document the toxicity of bafetinib in this cohort of patients. III. To describe the response rate, progression-free survival, and overall survival in patients with malignant brain tumors treated with bafetinib.

IV. To assess for the expression of Lyn and Fyn kinases and phosphorylation status in pre-treatment tumor samples.

OUTLINE:Patients undergo intracerebral microdialysis during debulking craniotomy or stereotactic biopsy. Beginning 24 hours later, patients receive oral bafetinib twice daily for 1 day. Beginning at least 2 weeks after craniotomy or 1 week after biopsy, patients continue to receive oral bafetinib twice daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 8 weeks thereafter.

Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases

BAFETINIB-P1-GBM-01: A Pilot Study Using Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Bafetinib in Patients With Recurrent Brain Tumors

National Cancer Institute (NCI)

City of Hope Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)	NCT01144260	B-Cell Chronic ...	bafetinib	18 Years -	CytRx
Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer	NCT01215799	Hormone Refract...	Bafetinib	18 Years -	CytRx
Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases	NCT01234740	Adult Anaplasti... Adult Anaplasti... Adult Anaplasti... Adult Giant Cel... Adult Glioblast... Adult Gliosarco... Adult Mixed Gli... Recurrent Adult... Tumors Metastat... Adult Anaplasti...	bafetinib microdialysis pharmacological... liquid chromato... mass spectromet... laboratory biom... protein express... western blottin... immunohistochem... therapeutic con...	18 Years -	City of Hope Medical Center
Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases	NCT01234740	Adult Anaplasti... Adult Anaplasti... Adult Anaplasti... Adult Giant Cel... Adult Glioblast... Adult Gliosarco... Adult Mixed Gli... Recurrent Adult... Tumors Metastat... Adult Anaplasti...	bafetinib microdialysis pharmacological... liquid chromato... mass spectromet... laboratory biom... protein express... western blottin... immunohistochem... therapeutic con...	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for bafetinib

Every month we try and update this database with for bafetinib 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 bafetinib

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