NCT00766324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

3.5 years

First QC Date

October 2, 2008

Last Update Submit

May 13, 2014

Conditions

Metastatic Hormone Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group

    within the first three months of treatment

Secondary Outcomes (2)

  • Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit

    all cycles

  • Overall safety profile

    all cycles

Study Arms (2)

A

EXPERIMENTAL
Drug: PHA-739358

B

EXPERIMENTAL
Drug: PHA-739358

Interventions

PHA-739358DRUG

6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle

A

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nerviano Medical Sciences. Clinical Research Dept.

Nerviano, Milano, 20014, Italy

Location

MeSH Terms

Interventions

danusertib

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

IT(1)