BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms
Intervention: Paclitaxel; Gemcitabine; Topotecan; Pegylated liposomal doxorubicin (PLD); BI 6727
Intervention description: Patients receive paclitaxel in a 4 week schedule; Patients receive gemcitabine in a 3 week schedule; Patients receive topotecan in 3 or 4 week schedule; Patients receive PLD in a 4 week schedule; Patients receive BI 6727 infusion every 3 weeks
Intervention MeSH terms: Paclitaxel; Gemcitabine; Doxorubicin; Liposomal doxorubicin; Topotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an international, randomized phase II trial. The aim is to assess the efficacy and
      the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent
      third and fourth lines platinum resistant/refractory ovarian cancer.

      100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50
      patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be
      continued until disease progression or unacceptable toxicity. Primary endpoint: disease
      control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version
      1.1.

      Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour
      response, biological progression free survival assessed by serum CA 125 according to
      Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease
      symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms
      questionnaires, pharmacokinetics of BI 6727.

      Others endpoints: biomarkers and pharmacogenetics analysis (optional)
    

Eligibility criteria:

        Inclusion criteria:

          1. Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian
             tube carcinoma.

          2. Platinum resistant or platinum refractory disease.

          3. Eastern Collaborative Oncology Group performance status < = 2.

          4. Life expectancy > = 3 months.

          5. At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version
             1.1).

          6. Adequate hepatic, renal and bone marrow functions.

          7. signed written informed consent prior to admission to the study.

        Exclusion criteria:

          1. Contre-indications for cytotoxic treatment according to the Summary of Product
             Characteristics (Arm B).

          2. Clinical evidence of active brain metastasis or leptomeningeal involvement.

          3. Other malignancy currently requiring active therapy.

          4. QTc prolongation according to Fridericia formula deemed clinically relevant by the
             investigator (e.g., congenital long QT syndrome, QTc according to Fridericia formula >
             470 ms).

          5. Hypersensitivity to one of the trial drugs or the excipients.

          6. Serious illness or concomitant non- oncological disease.

          7. Systemic anticancer therapy within 4 weeks before the start of the study.

          8. Evidence of ileus sor sub ileus.