Clinical trial · Interventional
Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels
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
NCT00083928CI-TRIAL-00009091completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Å6 subcutaneous injection | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females ≥18 years of age * Histologically or cytologically documented primary epithelial ovarian carcinoma, cancer of the Fallopian tube, or primary peritoneal carcinoma * Completion of first-line chemotherapy * Clinical remission as a result of chemotherapy * History of normal CA125 level after initial course of therapy * CA125 serum level has shown 2 consecutive rises based on 3 consecutive samples which are mutually \>= 28 days apart, provided that: 1. the 3rd sample is above the institution's ULN, and 2. the 3rd sample is confirmed by a 4th sample which is likewise higher than the 2nd sample value and is above the institution's ULN * No clinically evident disease progression, as assessed by history, physical examination, computed tomographic (CT) scan, or magnetic resonance imaging (MRI) * ECOG Performance Status of 0 or 1 * No clinically significantly abnormal clinical laboratory tests or concomitant illnesses * Ability and willingness to self-administer subcutaneous injections * Although pregnancy is extremely unlikely in this patient population because of the disease and prior treatment, patients who have the potential to become pregnant must have a negative pregnancy test and must agree to practice an effective method of contraception throughout the trial. Exclusion Criteria: * Persistent adverse events due to agents administered more than 4 weeks earlier * More than 1 course of previous chemotherapy for the qualifying cancer * Disease requiring chemotherapy or radiotherapy * Ascites * Recent history of active infection, gastrointestinal bleeding, thromboembolic disorders, or anticoagulation
References
Publications (0)
Data not yet available
No reference posted for this study.