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Sponsored by: |
EntreMed |
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Information provided by: | EntreMed |
ClinicalTrials.gov Identifier: | NCT00400348 |
The purpose of this study is to evaluate the efficacy, limited pharmacokinetics (PK), and safety of 1,000 mg of Panzem® NCD administered orally four times a day to patients with recurrent or resistant epithelial ovarian cancer.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: Panzem Nanocrystal Colloidal Dispersion (NCD) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | A Phase 2, Open-Label, Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion Administered Orally in Patients With Recurrent or Resistant Epithelial Ovarian Cancer |
Enrollment: | 18 |
Study Start Date: | October 2006 |
Study Completion Date: | November 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have histologically-confirmed:
Have near-normal organ function, as evidenced by laboratory data within 14 days prior to registration for protocol therapy:
Exclusion Criteria:
Have had any active cancer in addition to the epithelial ovarian cancer within the last 5 years, with the exception of:
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 |
Study Chair: | Daniela E. Matei, M.D. | Indiana University School of Medicine |
Responsible Party: | EntreMed, Inc. ( Chief Medical Officer ) |
Study ID Numbers: | ME-CLN-004 |
Study First Received: | November 14, 2006 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00400348 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Ovarian Diseases Ovarian Epithelial Cancer |
Recurrence Genital Diseases, Female 2-methoxyestradiol Tubulin Modulators Ovarian Cancer Endocrinopathy Endocrine Gland Neoplasms |
Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Ovarian Diseases |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site 2-methoxyestradiol Therapeutic Uses Tubulin Modulators Endocrine Gland Neoplasms |