NCT00564928

Brief Summary

To determine:

  • Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate cancer.
  • Group A - subjects who have not previously received chemotherapy
  • Group B - sujects who have received prior chemotherapy or could not tolerate chemotherapy.
  • Clinical response will be determined by PSA and radiological response

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

10 active sites

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

November 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

2.3 years

First QC Date

November 27, 2007

Last Update Submit

December 7, 2012

Conditions

Prostate CancerProstatic NeoplasmsCancer of the Prostate

Keywords

Hormone resistant prostate cancercastrate resistant prostate cancerHRPCCRPC

Outcome Measures

Primary Outcomes (1)

  • Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate

    12 Weeks

Secondary Outcomes (1)

  • Assess the safety and tolerability of IPI-504 in patients with hormone resistant prostate cancer

    12 Weeks

Study Arms (2)

IPI-504: Group A

EXPERIMENTAL

No Prior treatment for prostate cancer with cytotoxic chemotherapy (adjuvant or neoadjuvant chemotherapy is acceptable if completed \>2 years prior to study)

Drug: IPI-504

IPI-504: Group B

EXPERIMENTAL

* Must have evidence of radiographic metastatic disease * Must have been treated with a docetaxel-based chemotherapy regimen for HRPC with a minimum of 2 cycles with either PSA or RECIST defined radiographic progression during or witin 60 days of completeing docetaxel based chemotheraph or be intolerant of docetaxel-based chemotherapy * No more than three prior chemotherapies regimens for HRPC

Drug: IPI-504

Interventions

IPI-504DRUG

IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle

IPI-504: Group AIPI-504: Group B

Eligibility Criteria

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

You may qualify if:

  • Adenocarcinoma of the prostate
  • Resolution of acute toxic side effects of prior chemotherapy
  • Castration resistant disease despite ongoing chemical or surgical castration
  • ECOG 0-1
  • PSA greater than or equal to 2
  • Group A -
  • No Prior treatment for prostate cancer with cytotoxic chemotherapy (neoadjuvant, adjuvant treatment permitted if more than 2 years out)
  • Group B
  • Radiographic evidence of metastatic disease
  • Prior tx with docetaxel-minimum of 2 cycles with progression by RECIST or PSA or intolerant of tx
  • Maximum of 3 prior chemotherapies

You may not qualify if:

  • Small cell carcinoma of the prostate
  • Treatment within 2 weeks with approved, investigational, or small molecule
  • Treatment within 4 weeks with biologic or external beam radiation
  • ANC \<1,500 cells m3; Platelets \<100,000 mm3; Hemoglobin \<9.0g/dL
  • AST/ALT \>2.5 ULN
  • Serum creatinine \>3.0mg/dL
  • Active keratitis or keratoconjunctivitis
  • Previous treatment with 17-AAG, DMAG; or any other HSP-90 inhibitor
  • Baseline Qtc \>450 mses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

San Bernardino Urological Associates

San Bernardino, California, 92404, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Colorado at Denver

Denver, Colorado, 80045, United States

Location

MCG Cancer Center

Augusta, Georgia, 30912, United States

Location

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Parkland Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • William Oh, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 29, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2010

Study Completion

July 1, 2010

Last Updated

December 11, 2012

Record last verified: 2012-12

Locations

US(10)