Phase 2
N=110
BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
Ovarian Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01121406 ↗Enrolled (actual)
110
Serious AEs
41.3%
Results posted
Aug 2015
Primary outcome: Primary: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 — 30.6; 43.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel (Drug); Gemcitabine (Drug); Topotecan (Drug); Pegylated liposomal doxorubicin (PLD) (Drug); BI 6727 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 |
30.6; 43.1 | — |
| SECONDARY Progression Free Survival (PFS) |
13.1; 20.6 | — |
| SECONDARY Overall Survival (OS) |
60.1; 68.6 | — |
| SECONDARY Best Overall Response |
0; 0; 7; 8; 24; 24 | — |
| SECONDARY Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria |
10; 12; 33; 23; 4; 11 | — |
| SECONDARY Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria |
13.1; 20.6 | — |
| SECONDARY Time to Deterioration in Global Health Status/Quality of Life (QOL) |
NA; 39.6 | — |
| SECONDARY Time to Deterioration in Fatigue/Quality of Life (QOL) |
NA; 67.1 | — |
| SECONDARY Time to Deterioration in Pain/ Quality of Life (QOL) |
NA; 54.1 | — |
| SECONDARY Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL) |
NA; 47.2 | — |
| SECONDARY Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL) |
NA; 18.9 | — |
| SECONDARY Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |
4; 3; 1; 6; 19; 3 | — |
| SECONDARY Clinically Relevant Changes in Laboratory and ECG Data |
3.7; 12.7; 8.3; 9.3; 3.6; 0.0 | — |
| SECONDARY AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS |
2140 | — |
| SECONDARY AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS |
204 | — |
| SECONDARY AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS |
6240 | — |
| SECONDARY AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS |
1400 | — |
| SECONDARY Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma |
341 | — |
| SECONDARY Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma |
10.8 | — |
| SECONDARY Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma |
2.00 | — |
| SECONDARY Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma |
6.07 | — |
| SECONDARY t1/2; Terminal Half-life of BI 6727 BS in Plasma |
143 | — |
| SECONDARY t1/2; Terminal Half-life of CD 10899 BS in Plasma |
146 | — |
| SECONDARY MRT; Mean Residence Time of BI 6727 BS in the Body |
118 | — |
| SECONDARY CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration |
801 | — |
| SECONDARY Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS |
5690 | — |
| SECONDARY Biomarkers and Pharmacogenetics Analysis (Optional) |
— | — |
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
- Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian tube carcinoma.
- Platinum resistant or platinum refractory disease.
- Eastern Collaborative Oncology Group performance status = 3 months.
- At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version 1.1).
- Adequate hepatic, renal and bone marrow functions.
- signed written informed consent prior to admission to the study.
Exclusion criteria
- Contre-indications for cytotoxic treatment according to the Summary of Product Characteristics (Arm B).
- Clinical evidence of active brain metastasis or leptomeningeal involvement.
- Other malignancy currently requiring active therapy.
- 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).
- Hypersensitivity to one of the trial drugs or the excipients.
- Serious illness or concomitant non- oncological disease.
- Systemic anticancer therapy within 4 weeks before the start of the study.
- Evidence of ileus sor sub ileus.
Data sourced from ClinicalTrials.gov (NCT01121406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.