NCT00613652

CompletedPhase 1

A Phase I, Dose-Escalation Study to Assess the Safety and Dr...

AstraZeneca Source

AstraZeneca

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

D2782C00008

Study Type

interventional

Estimated enrollment

30

Locations

1 country

Sites

1

Timeline

Study Start

January 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2009

Actual (reported)

Study Completion

June 2009

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 30 participants
Study completion date: June 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 31, 2008
Actual (reported)
First Posted
February 13, 2008
Actual (reported)
Primary Completion
June 2009
Actual (reported)
Study Completion
June 2009
Actual (reported)

Last Updated: July 21, 2009
Status Verified: July 2009
Last Update Submitted: July 20, 2009

Conditions

Cancer Carcinoma Tumors

Keywords

solid tumorssolid malignancies

Outcome Measures

Primary Outcomes (1)

To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
weekly

Secondary Outcomes (1)

To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
weekly

Interventions

AZD4877Drug

10 mg IV (3 weeks treatment 1 week rest)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments.
Patients who usually have mild symptoms capable of walking and light and sedentary work.

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (1)

Research Site

Fukuoka, Japan

MeSH Terms

Conditions

NeoplasmsCarcinoma

Interventions

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

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

January 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2009

Actual (reported)

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Phase 1Completed

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Phase 1Active Not Recruiting

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

Phase 2Completed

NCT00329004

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Phase 1Completed

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Phase 1Completed

Patients who can stay in hospital at least during 4 weeks.

You may not qualify if:

Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin.
Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function.
Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.

Contact the study team to confirm eligibility.

Study Completion

June 2009

Actual (reported)

Last Updated

July 21, 2009

Record last verified: 2009-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00613652
Data provider: ClinicalTrials.gov
Source updated: 2009-07-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:24 UTC

Locations

JP(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations