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

NCT00695851 | Completed Phase 1

• 1 other identifier: 05-019
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

PCK3145; Prostate

Outcome Measures

Primary Outcomes (1)

• 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.

  conclusion of the study

Secondary Outcomes (2)

• 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.

  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.

  conclusion of the study

Study Arms (2)

1

EXPERIMENTAL

15 mg/m2 weekly of PCK3145

Drug: PCK3145

2

EXPERIMENTAL

7.5 mg/m2 twice per week of PCK3145

Drug: PCK3145

Interventions

PCK3145 DRUG

i.v. bolus either 15 mg/m2 weekly of PCK3145.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Ambrilia Biopharma, Inc.: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tigapotide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Susan Slovin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: March 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 30, 2009

Record last verified: 2009-03

Locations

US (1)