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Phase II Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients Undergoing Surgery or Radiation Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase II Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients Undergoing Surgery or Radiation Therapy


Inclusion Criteria:



1. Have a histologic diagnosis of prostate cancer (in more than 1 core) with one of the
following:

- Gleason > 6,

- Unilateral Gleason 6 in ≥ 3 cores,

- bilateral Gleason 6,

- PSA > 10.0 ng/ml.

2. Age ≥18 years.

3. Has an ECOG Performance Status 0-2 or Karnofsky 60-100.

4. Has the following laboratory values at study entry: absolute neutrophil count (ANC) ≥
1,500 cells/μL; platelet count ≥ 100,000 cells/μL; hemoglobin ≥ 9 g/dL; total serum
bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); ALT and AST ≤ 1.5 x
institutional ULN if alkaline phosphatase is ≤ULN creatinine and BUN ≤ 1.5 x
institutional upper limit of normal (ULN)

5. Signed informed consent

6. No new, undiagnosed bone pain or has a negative bone scan. (within 2 months of
consent) If there is no bone pain, then a bone scan is not required.

Exclusion Criteria:

1. Has documented metastatic disease.

2. Has received a prior chemotherapy or androgen ablation.

3. Has received prior immunotherapy.

4. Has been previously treated with Strontium, Samarium, other systemic radioisotopes or
radiation therapy.

5. Has diagnosis of congestive heart failure

6. Currently taking anticoagulation medications, i.e., coumadin or heparin. Over the
counter aspirin and ibuprofen are allowed.

7. Is receiving any other investigational agents for cancer.

8. Has a history of other malignancy within the last 5 years, which could affect the
diagnosis or assessment of prostate cancer.

9. Has a serious intercurrent illness with a life expectancy of less than 5 years.

10. Has a concomitant medical, psychological, or social circumstance, which would
interfere with compliance with the protocol treatment and follow-up.

11. Use of any herbal or alternative regimens, which may have antineoplastic or hormonal
activity (including but not limited to finasteride, dutasteride, Saw Palmetto,
PC-SPES, shark cartilage, etc), is prohibited while receiving study treatment.

12. Clinical stage T3 or T4 and PSA >10 ng/ml and Gleason > 8.

13. Patient is to receive adjuvant androgen ablation with the radiation.

14. EKG which shows a baseline QTc > 450 msec or ischemic changes. For ischemic changes,
patient will be eligible if evaluated and cleared by internal medicine.

15. Previous history of drug-induced QTc prolongation and/or concurrent treatment with
medications that are known to produce or are suspected of QT prolongation.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA (Prostate Specific Antigen)

Outcome Time Frame:

3 months post surgery or end of radiation treatment

Safety Issue:

No

Principal Investigator

Gregory P. Swanson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center at San Antonio

Authority:

United States: Food and Drug Administration

Study ID:

HSC20100308H

NCT ID:

NCT01705652

Start Date:

July 2011

Completion Date:

December 2019

Related Keywords:

  • Prostate Cancer
  • nexrutine
  • prostate cancer
  • Prostatic Neoplasms

Name

Location

The University of Texas Health Science Center at San Antonio, study site: ALM VA HospitalSan Antonio, Texas  78229