Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Lymphoproliferative Disorders

Paraproteinemias

Hematologic Diseases

Hemorrhagic Disorders

Neoplasms by Histologic Type

Blood Protein Disorders

Immunoproliferative Disorders

Vascular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Coagulants

Anti-Infective Agents

Antirheumatic Agents

Bortezomib

Hemostatics

Rifamycins

Rifamycin SV

Patients will be enrolled into 3 groups which will run sequentially. Groups A and B will receive AT7519M only, whereas Group C will receive AT7519M in combination with Bortezomib.

Part A: Nine patients will receive AT7519M as an intravenous infusion on days 1, 4, 8 and 11 of a three week cycle. The starting dose of AT7519M will be 21mg/m\^2/dose and will be increased to 27mg/m\^2/dose during subsequent cycles in the absence of AT7519M-related toxicities.

Part B: Amendment clarified there will be no further exploration of AT7519M as a monotherapy.

Part C: Amendment modified dose escalation to a conventional 3 + 3 design with a maximum total of 14 patients will be treated at the maximum tolerated dose.

AT7519M

Part C will treat between 3-26 patients with a combination of bortezomib and AT7519M in a dose escalation design. The starting doses for the dose escalation are bortezomib 1 mg/m2 and AT7519M 14 mg/m2.

The purpose of this study is to determine whether AT7519M alone or AT7519M plus bortezomib are effective treatments in patients with previously treated multiple myeloma.

The clinical study AT7519M/0004 is an open-label multicenter study to investigate the efficacy of AT7519M alone and AT7519M in combination with bortezomib in patients with previously treated multiple myeloma (MM).

Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma

A Phase I/II Open-label Multicenter Study of AT7519M Alone and in Combination With Bortezomib in Patients With Previously Treated Multiple Myeloma

Efficacy will be assessed using the International Multiple Myeloma Working Group (IMWG) Response Criteria

The pharmacokinetic evaluation will include the calculation of plasma clearance and elimination phase half-life for AT7519M and bortezomib

The MTD will be based on the incidence of dose limiting toxicities

Multiple Myeloma Research Consortium

Astex Pharmaceuticals, Inc.

Lymphoma

Lymphoma, Mantle-Cell

Lymphatic Diseases

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

AT7519M: 27 mg/m2 IV injection, 1 hour infusion, 27 mg/m2/day twice weekly x 2 weeks every 3 weeks (days 1, 4, 8 and 11)

John Kuruvilla

The purpose of this study is to find out what effects a new drug AT7519M has on mantle cell lymphoma.

This research is being done because AT7519M has been shown to shrink tumours in animals and has been studied in a few people and seems promising but it is not clear if it can offer better results than standard treatment.

A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed Mantle Cell Lymphoma

objective response rate of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed mantle cell lymphoma (MCL).

NCIC Clinical Trials Group

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Dose: 27 mg/m2, IV injection, 1 hour infusion Schedule: 27 mg/m2/day twice weekly x 2 weeks every 3 weeks (days 1, 4, 8 and 11)

Matthew D Seftel

The purpose of this study is to find out what effects a new drug AT7519M has on chronic lymphocytic leukemia.

This research is being done because AT7519M has been shown to shrink tumours in animals, has been studied in a few people and seems promising, but it is not clear if it can offer better results than standard treatment.

A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia

Efficacy (as assessed by objective response rate) of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed and/or refractory chronic lymphocytic leukemia.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma	NCT01183949	Multiple Myelom...	AT7519M Bortezomib	18 Years -	Astex Pharmaceuticals, Inc.
A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed Mantle Cell Lymphoma	NCT01652144	Mantle Cell Lym...	AT7519M	18 Years -	Canadian Cancer Trials Group
A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia	NCT01627054	Chronic Lymphoc...	AT7519M	18 Months -	Canadian Cancer Trials Group
Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma	NCT01183949	Multiple Myelom...	AT7519M Bortezomib	18 Years -	Astex Pharmaceuticals, Inc.
A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed Mantle Cell Lymphoma	NCT01652144	Mantle Cell Lym...	AT7519M	18 Years -	Canadian Cancer Trials Group

Spots Global Cancer Trial Database for at7519m

Every month we try and update this database with for at7519m 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 at7519m

Every month we try and update this database with for at7519m 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 at7519m 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.