Clinical trial · Interventional
A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)
Obligatory Post-Registration Open-Label, Non-Comparative Multicenter Study of Efficacy and Tolerance Rate of Caelyx as Monotherapy in Patients With Epithelial Ovarian Cancer, Resistant to Previous Platinum Therapy.
- 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 aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m\^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian cancer, resistant to previous platinum therapy.
Conditions
Conditions (1)
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 Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated Liposomal Doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
- interventionNames
- Drug: Pegylated Liposomal Doxorubicin hydrochloride
Primary outcomes (4)
- measure
- Number of Participants With Complete Response
- timeFrame
- 4 weeks after chemotherapy completed
- description
- Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
- measure
- Number of Participants With Partial Response
- timeFrame
- 4 weeks after chemotherapy completed
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent. * Women must be greater than or equal to 18 years of age, of any race. * Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation). * Morphology (cytology or histology) confirmed diagnosis of epithelial ovarian cancer. * Patients with 1 or more measurable and/or evaluable tumors, according to the results of CT, MRT scans or X-ray, etc. * Patients, including those after primary surgical treatment, who had previously received platinum chemotherapy and in whom second-line therapy is indicated. * Karnofsky performance status above 60%. * Left ventricular ejection fraction above 50% (according to the results of echocardiography). * Adequate bone marrow function as indicated by: * Platelets \>100x10\^9/L * Haemoglobin \> 9 g/dL * Absolute neutrophil count \>1.5x10\^9/L * Adequate renal function as indicated by: * Serum creatinine \< 1.5 х ULN * Adequate liver function as indicated by: * Bilirubin level and AST or ALT activity \< 2 х ULN (with the exception of cases related to primary disease). Exclusion Criteria: * Women who are pregnant or nursing. * Subjects who have not observed the designated washout periods for any of the prohibited medications. * Subjects who have used any investigational product within 30 days prior to enrollment. * Medical history indicating serious concomitant diseases, such as congestive heart failure of II NYHA class or higher, insulin-dependent diabetes mellitus, clinically significant liver disease, mental disorders. * Non-controlled bacterial, viral or fungal infections. * Conditions and reasons (medical, social and psychological) that might prevent adequate follow-up of patients. * Any other active primary tumor under treatment (except basal or squamous cell carcinoma or in situ cervix carcinoma). * Patient has symptomatic metastasis to brain.
References
Publications (0)
Data not yet available