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Sponsored by: |
EntreMed |
Information provided by: | EntreMed |
ClinicalTrials.gov Identifier: | NCT00444314 |
This open-label, multicenter, Phase 2 trial, will assess the anti tumor activity, safety and pharmacodynamics, of Panzem® NCD with or without Sunitinib Malate in patients with metastatic renal cell carcinoma progressing on Sunitinib Malate.
Condition | Intervention | Phase |
Metastatic Renal Cell Carcinoma |
Drug: Panzem® NCD Drug: Sunitinib Malate |
Phase II |
MedlinePlus related topics: | Cancer |
Drug Information available for: | Sunitinib Sunitinib malate Malic acid 2-Methoxyestradiol |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of 2-Methoxyestradiol Nanocrystal Colloidal Dispersion Alone and in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma Progressing on Sunitinib Malate |
Estimated Enrollment: | 82 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental |
Drug: Panzem® NCD
NCD suspension, 1500 mg TID daily for 6 week cycles
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B: Experimental |
Drug: Panzem® NCD
NCD suspension, 1500 mg TID daily for 6 week cycles
Drug: Sunitinib Malate
Sunitinib Malate, highest tolerated dose (patient's current dose), daily oral administration for 4 weeks, with 2 week break in 6 week cycle
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have previously received or be currently receiving sunitinib malate (Sutent) with evidence of disease progression while receiving sunitinib malate (as evident by new lesions on CT/MRI/bone scan or unequivocal growth in measurable tumor lesions).
Note: Patients will be stratified to:
A: Patients previously treated with sunitinib malate. At least 4 week washout since last treatment administered is required before patient is eligible for study. Once patients meet all other eligibility criteria, they will be treated with Panzem® NCD alone.
B: Patients currently still on sunitinib. Patients will continue to receive their current dose/schedule of sunitinib. Once eligibility determined, patients will be started on Panzem® NCD concurrently with their sunitinib. No drug washout of sunitinib malate is required for this stratification.
Note: Enrollment to the individual stratification will stop once that stratification has met its accrual goal.
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
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, 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-008 |
First Received: | March 6, 2007 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00444314 |
Health Authority: | United States: Food and Drug Administration |
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