Clinical trial · Interventional
Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer
An Open-label, Randomised Phase II Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer
NCT03335241CI-TRIAL-00030281unknownPhase 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 the study is to evaluate the efficacy and toxicity of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.
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 Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine and Pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
| Pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Fludarabine and Pegylated liposomal doxorubicin
- interventionNames
- Drug: Fludarabine and Pegylated liposomal doxorubicin
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: Pegylated liposomal doxorubicin
- interventionNames
- Drug: Pegylated liposomal doxorubicin
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- Up to four years
- description
- Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary. * Platinum resistant or refractory ovarian cancer * At least treated with one line of platinum-based chemotherapy * Female, age ≥18 years and ≤70 years, signed informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version * Patients must have a life expectancy of at least 3 months. * Patients must have adequate organ function as defined by the following criteria: * White blood cell count ≥ 3 x 10\^9/L, Absolute neutrophil count (ANC) (≥ 1.0 x 10\^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 80 x 10\^9/L * Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN * Serum creatinine ≤ 1 x ULN * Symptomatic central nervous system (CNS) metastasis Exclusion Critera: * Has known allergies to any of the excipients. * Prior treatment with adriamycin or other anthracycline at cumulative doses greater than 550 mg/m2 after 6 cycles of pegylated liposomal doxorubicin * LVEF (left ventricular ejection fraction) \<50% * Had disease recurrence/progression within 6 months after the administration of doxorubicin chemotherapy * History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1. * Known significant chronic liver disease, such as cirrhosis or active hepatitis * Uncontrollable active infection
References
Publications (0)
Data not yet available
No reference posted for this study.