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| Sponsor: | Ångstrom Pharmaceuticals |
|---|---|
| Information provided by: | Ångstrom Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00083928 |
Purpose
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 |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Carcinoma |
Drug: Å6 subcutaneous injection |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations
Show 24 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00083928 History of Changes |
| Other Study ID Numbers: | Å6-003 |
| Study First Received: | June 3, 2004 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Asymptomatic subcutaneous CA125 Progression |
Angstrom Ångstrom ovarian cancer |
|
Carcinoma Ovarian Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |