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Sponsored by: |
EntreMed |
Information provided by: | EntreMed |
ClinicalTrials.gov Identifier: | NCT00394810 |
This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacokinetics, of Panzem® NCD in patients with metastatic, docetaxel refractory, androgen-independent prostate cancer.
Condition | Intervention | Phase |
Prostate Cancer |
Drug: Panzem® NCD |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | 2-Methoxyestradiol |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Efficacy and Pharmacodynamic Study of 2-Methoxyestradiol Nanocrystal Colloidal Dispersion(Panzem® NCD) in Patients With Taxane-Refractory, Metastatic,Hormone-Refractory Prostate Cancer |
Enrollment: | 21 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Panzem® NCD
suspension, 100 mg/mL, four times daily continuous dosing
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pts must have evidence of progressive metastatic disease (e.g., new lesions on bone scan or new/enlarging lesions on computerized tomography [CT] scan) or known metastatic disease and rising PSA, during or after treatment with a taxane-based regimen (as well as any other subsequent non-cytotoxic therapy).
Pts must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure.
For pts previously treated with flutamide (Eulixin), Nilutamide (Nilandron), or bicalutamide (Casodex): pts must have discontinued flutamide 4 weeks or more prior to registration with continued evidence of progressive disease. For bicalutamide or nilutamide, pts must have discontinued the drug 6 weeks or more prior to registration with evidence of progressive disease.
• Disease progression following anti-androgen withdrawal needs to be confirmed by a rising PSA after the required 4-6 week washout period (e.g. PSA level higher than the last PSA obtained while on anti-androgen therapy).
Pts must have near normal organ and marrow function within 2 weeks prior to registration as defined below:
Exclusion Criteria:
The use of bisphosphonates (i.e. pamidronate sodium or zoledronic acid) will be allowed provided that the patient has been receiving that medication for 4 weeks or more with evidence of progressive disease as outlined above.
• Pts will not be allowed to start bisphosphonate while receiving protocol treatment unless clinically indicated (will need approval of the study principal investigator). Those patients already on a bisphosphonate will need to continue to receive the bisphosphonate as previously scheduled.
Pts must not have had prior radiotherapy within 4 weeks prior to registration. Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope.
• If a pt requires palliative radiotherapy, two consecutive rises (baseline value must be obtained after completion of radiation treatment) in PSA measurement are necessary, each separated from the previous by a minimum of two weeks.
United States, Indiana | |||||
Indiana University Cancer Center | |||||
Indianapolis, Indiana, United States, 46202 | |||||
United States, Maryland | |||||
Johns Hopkins University School of Medicine | |||||
Baltimore, Maryland, United States, 21205 | |||||
United States, Massachusetts | |||||
Dana-Farber Cancer Institute | |||||
Boston, Massachusetts, United States, 02115 | |||||
United States, Wisconsin | |||||
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |||||
Madison, Wisconsin, United States, 53792 |
EntreMed |
Principal Investigator: | Glenn Liu, MD | University of Wisconsin, Madison |
Responsible Party: | EntreMed, Inc. ( Chief Medical Officer ) |
Study ID Numbers: | ME-CLN-006 |
First Received: | October 30, 2006 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00394810 |
Health Authority: | United States: Food and Drug Administration |
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