Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Recurrence

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Promyelocytic, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Acute Promyelocytic Leukemia

intravenous infusion administered on days 1, 2 and 3

AZD4877

Gregory A Curt, MD

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML).

For enrollment information see the Central Contact information below

Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)

A Phase I/II, Open-Label, Multi-Center, Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD4877 Administered on Days 1, 2 and 3 in Adult Patients With Recurrent or Refractory Acute Myelogenous Leukemia (AML) Excluding Promyelocytic Leukemia

To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)

Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.

AstraZeneca

AZD4877 \[ Time Frame: administered on days 1,2 and 3\]

< 18 Years

>=18 - < 65 Years

>=65 - < 75 Yrs

>=75 Yrs

Age, Customized

Sex: Female, Male

White

Black or African American

Race/Ethnicity, Customized

On 16 June 2009, the study was terminated for a lack of efficacy. None of the 8 patients had experienced CR or CRi. The secondary efficacy outcome measures were not evaluated due to early termination and small number of participants.

Gerard Lynch

To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs)

8 of 9 patients in Part B were evaluable for response following a maximum of 2 courses of induction therapy.

To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR)

To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ]

To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR)

To Evaluate the Safety and Tolerability of AZD4877 on a Daily x 3 Schedule by Assessment of Adverse Events, Non-hematologic Labs and Vital Signs

Overall Study

Carcinoma

The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies

A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients

A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly in Japanese Adult Patients With Advanced Solid Malignancies

Immune System Diseases

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

intravenous infusion administered twice a week for 2 weeks

Jeffrey Skolnik, MD

Lea Burke

This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth

Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877

A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Twice a Week in Adult Patients With Advanced Solid Malignancies Including Lymphoma

Judith Ochs, MD

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experiences by patients that receive AZD4877 on a weekly basis

Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors

A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly or Every Two Weeks in Patients With Advanced Solid Malignancies

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Ureteral Neoplasms

Pelvic Neoplasms

Urethral Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Ureteral Diseases

Urethral Diseases

Urethral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Antimitotic Agents

Gary Hudes, MD

The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth), can reduce tumor sizes in patients with bladder cancer

A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer

A Phase II, Single Arm, Single Agent, Multicentre, Adaptive 2-Stage Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD4877 Administered Weekly in Patients With Recurrent Advanced Urothelial Cancer

Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).

Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).

Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)

Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.

Time in weeks from the first administration of study drug to death.

Jeffrey Skolnik, MD/Associate Medical Director

AZD4877 25 mg (Intravenous (IV), 25mg weekly)

>=18 - <65 Years

>=65 - <75 Years

>=75 Years

Black and African

Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).

Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)

Disease Control Rate (DCR)

Duration of Objective Tumor Response (OTR)

Progression Free Survival (PFS)

Overall Survival (OS)

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a weekly basis in these diseases.

Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies

A Phase I, Open-label, Dose Escalation Study to Assess the Safety, Tolerability & Pharmacokinetics of AZD4877 Administered Once Weekly in Adult Patients With Recurrent or Refractory AML, PH Negative ALL, NHL or MN

Spots Global Cancer Trial Database for azd4877

Every month we try and update this database with for azd4877 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)	NCT00486265	Acute Myelogeno...	AZD4877	18 Years -	AstraZeneca
A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients	NCT00613652	Cancer Tumors Carcinoma	AZD4877	20 Years - 75 Years	AstraZeneca
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877	NCT00471367	Lymphoma NHL Non-Hodgkin Lym...	AZD4877	18 Years -	AstraZeneca
Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors	NCT00389389	Neoplasms	AZD4877	18 Years -	AstraZeneca
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer	NCT00661609	Bladder Cancer Transitional Ce... Urethra Cancer Ureter Cancer Renal Pelvis Ca...	AZD4877	18 Years -	AstraZeneca
Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors	NCT00389389	Neoplasms	AZD4877	18 Years -	AstraZeneca
Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies	NCT00460460	Lymphoma	AZD4877	18 Years -	AstraZeneca
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877	NCT00471367	Lymphoma NHL Non-Hodgkin Lym...	AZD4877	18 Years -	AstraZeneca

Spots Global Cancer Trial Database for azd4877

Every month we try and update this database with for azd4877 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 azd4877 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.