Phase I, Open-label, Dose Escalation of AZD4877 in Hemato... | NCT00460460

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

NCT00460460

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Jan 25, 2011Estimated

Enrollment

75Estimated

Phase

Phase 1

Conditions

Lymphoma

Interventions

AZD4877

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was terminated due to low enrollment

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Apr 12, 2007

First Submission Date that Met QC Criteria

Apr 12, 2007

First Posted Date

Apr 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2011

Last Update Posted Date

Jan 25, 2011Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Name	Type	Description	Arm Group Labels	Other Names
AZD4877	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with AML, a certain type of ALL, NHL and MM
certain types of cancer of the lymph nodes
certain types of leukemias (blood cancers)
disease has or will fail with other treatments
relatively good overall health other than your cancer

Exclusion Criteria:

poor bone marrow function (not producing enough blood cells)
serious heart conditions
poor liver or kidney function

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Judith Ochs, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research site		Buffalo	New York		United States
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma
D009369	Neoplasms
D007938	Leukemia
D054219	Neoplasms, Plasma Cell

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C568512	N-(3-aminopropyl)-N-(1-(5-benzyl-3-methyl-4-oxo-(1,2)thiazolo(5,4-d)pyrimidin-6-yl)-2-methylpropyl)-4-methylbenzamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided