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Dose-Seeking Trial of PCK3145 in Asymptomatic, Castrate Metastatic Prostate Cancer Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695851
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : March 30, 2009
Ambrilia Biopharma, Inc.
Information provided by:
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE June 10, 2008
First Posted Date  ICMJE June 12, 2008
Last Update Posted Date March 30, 2009
Study Start Date  ICMJE March 2005
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
To explore the PK profiles and their association with two dosing schedules of PCK3145 given iv bolus in patients with asymptomatic castrate metastatic prostate cancer. [ Time Frame: conclusion of the study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00695851 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
  • To explore the association of 2 dosing schedules of PCK3145 with MMP-9 levels in asymptomatic pts with castrate metastatic prostate cancer. The results of this analysis will be used to establish a dose on which to build a phase II randomized trial. [ Time Frame: conclusion of the study ]
  • To assess the safety and toxicity of PCK3145 at a dose of 150mg/m² i.v. bolus given weekly for 16 weeks. [ Time Frame: conclusion of the study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Dose-Seeking Trial of PCK3145 in Asymptomatic, Castrate Metastatic Prostate Cancer Patients.
Official Title  ICMJE A Phase I Randomized Dose-Seeking Trial of PCK3145 in Asymptomatic, Castrate Metastatic Prostate Cancer Patients.
Brief Summary The purpose of this study is to find out whether giving a drug called PCK3145 can reduce the level of a protein in the blood called MMP-9 as well as to find out how long the drug will remain in your system over time. This drug has been tested previously in prostate cancer patients abroad and has been shown to be safe with minimal side effects. However, we do not know whether changes in MMP-9 levels correlate with tumor shrinkage or symptom improvement. We would also like to evaluate the potential pain relief (analgesic) effect of PCK3145 at 15mg/m² i.v. weekly for 12 weeks on patients with both symptomatic and asymptomatic castrate metastatic prostate cancer who are dependent on opioid analgesics. We would also like to monitor pain through a brief pain questionaire, and determine the impact on markers of bone turnover.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: PCK3145
    i.v. bolus either 15 mg/m2 weekly of PCK3145.
  • Drug: PCK3145
    by i.v. bolus 7.5 mg/m2 twice per week of PCK3145
Study Arms  ICMJE
  • Experimental: 1
    15 mg/m2 weekly of PCK3145
    Intervention: Drug: PCK3145
  • Experimental: 2
    7.5 mg/m2 twice per week of PCK3145
    Intervention: Drug: PCK3145
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2009)
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2008)
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who have castrate metastatic prostate cancers are eligible based on the following criteria.
  • Patients with prostate cancer must have castrate metastatic disease (i.e. disease progression following castration or treatment with a gonadotropin releasing hormone analog. Patients with prostate cancer may have progressing metastatic disease on imaging studies (bone scan, CT scan or MRI) in addition to a rising PSA.
  • Biochemical progression will be defined as: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or two rising PSA values more than one month apart, where the percentage increase over the range of values is at least 25%.
  • Maintaining castrate status: Patients who have not undergone surgical orchiectomy should continue on medical therapies [i.e. gonadotropin releasing hormone analogs] to maintain castrate levels of serum testosterone. Patients who are receiving an anti-androgen as part of first line hormonal therapy must have shown progression of disease off the anti-androgen prior to enrollment.
  • Histologically confirmed diagnosis of prostate cancer per MSKCC review.
  • No limitations on the duration of or number of prior therapies.
  • Age ≥ 18 years
  • Karnofsky performance status ≥ 70% (ECOG ≤ 1.0).
  • Life expectancy of greater than 6 months.
  • Hematologic: WBC ≥ 3000K/μl.
  • Absolute neutrophil count ≥ 1500 K/μl
  • Platelet count ≥ 100,000 K/μl.
  • Hepatic: Total Bilirubin - within normal institutional limits
  • AST < 1.5 x ULN, ALT < 1.5 x ULN.
  • Renal: Creatinine < 2.0 or creatinine clearance > 55 mL/min
  • Coagulation: Prothrombin time - Less than or equal to the ULN (upper limit of normal) unless patient is taking anticoagulants
  • Patients must have recovered from the acute toxicities of any prior therapy, and not received chemotherapy, radiation therapy or other investigational anticancer therapeutic drugs for at least 4 weeks prior to entry.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Testosterone < 50 ng/dl
  • Patients may be symptomatic and must be dependent on opioid analgesics or nonsteroidal anti-inflammatory drugs

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from the adverse events due to agents administered more than 4 weeks earlier.
  • Patients may not be receiving any other investigational agents.
  • Patients with active brain metastases or epidural disease
  • Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • No current therapy with alternative/complementary drugs such as PC Plus, saw palmetto or Zyflamend.
  • No rectal bleeding except that seen following radiation proctitis or known history of hemorrhoids.
  • Non-prostate primary carcinoma except for non-melanoma skin cancer within previous 5 years.
  • No uncontrolled cardiac arrhythmias.
  • Patient taking steroids for cord compression or pain control are excluded. Patient on steroids for chronic conditions such as arthritis or asthma or on chronic hydrocortisone post ketoconazole will be permitted.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00695851
Other Study ID Numbers  ICMJE 05-019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Slovin, MD, Memorial Sloan-Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Ambrilia Biopharma, Inc.
Investigators  ICMJE
Principal Investigator: Susan Slovin, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP