PHA-739358 for Treatment of Hormone Refractory Prostate C... | NCT00766324

Studies
PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

NCT00766324

Sponsor

Nerviano Medical Sciences

Status

Completed

Last Update Posted

May 28, 2014Estimated

Enrollment

118Actual

Phase

Phase 2

Conditions

Metastatic Hormone Refractory Prostate Cancer

Interventions

PHA-739358
PHA-739358

Countries

Italy

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

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Mar 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Oct 2, 2008

First Submission Date that Met QC Criteria

Oct 2, 2008

First Posted Date

Oct 3, 2008Estimated

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

May 13, 2014

Certification/Extension First Submitted that Passed QC Review

May 13, 2014

Certification/Extension First Posted Date

May 28, 2014Estimated

Last Update Submitted Date

May 13, 2014

Last Update Posted Date

May 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: PHA-739358
B	Experimental		Drug: PHA-739358

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PHA-739358	Drug	6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group		within the first three months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit		all cycles
Overall safety profile		all cycles

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Metastatic hormone refractory prostate cancer progressing after docetaxel based therapy
Adequate bone marrow, liver and kidney function

Exclusion Criteria:

More than one prior chemotherapy line
Uncontrolled hypertension
Brain or leptomeningeal disease
Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nerviano Medical Sciences. Clinical Research Dept.		Nerviano	Milano	20014	Italy

Intervention Browse Module

MeSH Terms

ID	Term
C523797	danusertib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided