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Sponsored by: |
Ångstrom Pharmaceuticals |
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Information provided by: | Ångstrom Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00083928 |
The purpose of this study is to determine whether injections of Å6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of CA 125 levels.
Condition | Intervention | Phase |
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Ovarian Cancer Primary Peritoneal Carcinoma |
Drug: Å6 subcutaneous injection |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Randomized, Double-Blind Trial of the Clinical Activity and Safety of Å6 in Patients With Asymptomatic CA125 Progression of Epithelial Ovarian Cancer After First-Line Chemotherapy |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
CA125 serum level has shown 2 consecutive rises based on 3 consecutive samples which are mutually >= 28 days apart, provided that:
Exclusion Criteria:
Study ID Numbers: | Å6-003 |
Study First Received: | June 3, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00083928 |
Health Authority: | United States: Food and Drug Administration |
Asymptomatic subcutaneous CA125 Progression |
Angstrom Ångstrom ovarian cancer |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Disease Progression Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms |
Ovarian Diseases Ovarian epithelial cancer Carcinoma Genital Diseases, Female Endocrinopathy Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Adnexal Diseases |