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Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus InvestigatorĀ“s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Neoplasms

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Trial Information

Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus InvestigatorĀ“s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Control Rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1

Outcome Time Frame:

Week 24

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Belgium: Federal Agency for Medicinal and Health Products

Study ID:

1230.18

NCT ID:

NCT01121406

Start Date:

April 2010

Completion Date:

November 2013

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

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