CMAB vs IMAB in Metastatic Prostate Cancer | NCT00255268

Studies
CMAB vs IMAB in Metastatic Prostate Cancer

NCT00255268

Sponsor

AstraZeneca

Status

Withdrawn

Last Update Posted

Aug 28, 2007Estimated

Enrollment

15Estimated

Phase

Phase 4

Conditions

Metastatic Prostate Cancer

Interventions

Goserelin
Bicalutamide

Countries

Mexico

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

Aug 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 26, 2005

First Submission Date that Met QC Criteria

Nov 17, 2005

First Posted Date

Nov 18, 2005Estimated

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

Aug 24, 2007

Last Update Posted Date

Aug 28, 2007Estimated

Description Module

Brief Summary

To evaluate the efficacy, safety and survival of two treatment regimens: Continuous Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated. QoL evaluation is also included.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Measure	Description	Time Frame
Time to progression

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological diagnosis of D2 of Adenocarcinoma,
Naivety to treatment
Valuable bone metastasis

Exclusion Criteria:

Hematological, liver or renal toxicity Grade IV
Severe and active infections

Accepts Healthy Volunteers

Sex

Male

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
AstraZeneca Mexico Medical Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Metepec			Mexico
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017273	Goserelin
C053541	bicalutamide

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Goserelin	Drug
Bicalutamide	Drug