Clinical trial · Interventional
Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer
An Open-Label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients With Persistent or Progressive Disease After, or Relapse Within One Year of, Completion of Standard First Line Therapy
NCT00523380CI-TRIAL-00026199completedPhase 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)
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| caelyx (pegylated liposomal doxorubicin) | Drug | Doxorubicin | ALIAS |
| recombinant interleukin-21 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: recombinant interleukin-21
- Drug: caelyx (pegylated liposomal doxorubicin)
Primary outcomes (1)
- measure
- Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
- timeFrame
- after max. 6 treatment cycles
Secondary outcomes (5)
- measure
- Pharmacokinetics
- timeFrame
- Initially
- measure
- IL-21 antibody formation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced epithelial Ovarian Cancer (stage IIB-IV) * Persistent or progressive disease after or relapse within one year of completion of first line therapy * Measurable or assessable disease * Eastern Cooperative Oncology Group status less than or equal to 2 Exclusion Criteria: * History of any other active malignancy * Signs of CNS metastasis * More than one prior chemotherapy regimen * Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks * First line chemotherapy completed at least 1 month prior to start of treatment
References
Publications (0)
Data not yet available
No reference posted for this study.