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A Phase 2 Open-Label Study to Investigate the Pharmacodynamics and Clinical Activity of IPI-504 in Patients With Castration-Resistant Prostate Cancer Stratified by Prior Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer, Prostatic Neoplasms, Cancer of the Prostate

Thank you

Trial Information

A Phase 2 Open-Label Study to Investigate the Pharmacodynamics and Clinical Activity of IPI-504 in Patients With Castration-Resistant Prostate Cancer Stratified by Prior Chemotherapy


IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's
role in the cell is to control the proper folding, function, and viability of various
"client" proteins. Many of these client proteins (such as AKT, Her-2, Bcr-Abl, PDGFR-α, and
c-Kit) are oncoproteins or important cell signaling proteins. Inhibition of HSP-90 leads to
the proteasomal degradation of these proteins.

In patients with HRPC,there are several proteins that are important in the progression of
HRPC, including AR, AKT and Her-2. All of these are client proteins of Hsp90 and in
response to Hsp90 inhibition are degraded by their proteasome. Preclinical studies have
shown that Hsp90 inhibition causes a dose dependent degradation of these client proteins
and growth inhibition of prostate cancer in xenograft tumors.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 Weeks

Safety Issue:

No

Principal Investigator

William Oh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

IPI-504-04

NCT ID:

NCT00564928

Start Date:

November 2007

Completion Date:

July 2010

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms
  • Cancer of the Prostate
  • Hormone resistant prostate cancer
  • castrate resistant prostate cancer
  • HRPC
  • CRPC
  • Neoplasms
  • Prostatic Neoplasms

Name

Location
Stanford University Medical Center Stanford, California  94305-5408
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Wayne State University Detroit, Michigan  48202
San Bernardino Urological Associates San Bernardino, California  
University of Chicago Hospitals Chicago, Illinois  60637
University of Colorado at Denver Denver, Colorado  80045
MCG Cancer Center Augusta, Georgia  30912
Parkland Hospital Dallas, Texas  75390