BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasms

Treatments: Drug: Topotecan; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin (PLD); Drug: BI 6727

Study type: Interventional

Funder types: Industry

Identifiers

NCT01121406

2009-015770-35 (EudraCT Number)

1230.18

Details and patient eligibility

About

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)

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

BI 6727

Experimental group

Description:

Patients receive BI 6727 infusion every 3 weeks

Treatment:

Drug: BI 6727

Cytotoxic

Active Comparator group

Description:

At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin

Treatment:

Drug: Pegylated liposomal doxorubicin (PLD)

Drug: Topotecan

Drug: Paclitaxel

Drug: Gemcitabine