Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors

NCT ID: NCT01022853

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-02-28

Brief Summary

The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in patients with advanced or metastatic solid tumours.

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIBF 1120 and BI 6727

Finding Maximum Tolerated Dose of BI 6727 in combination with BIBF 1120

Group Type: EXPERIMENTAL

BI 6727

Intervention Type: DRUG

intravenous each 21 days

BIBF 1120

Intervention Type: DRUG

oral continuously

Interventions

BI 6727

intravenous each 21 days

Intervention Type: DRUG

BIBF 1120

oral continuously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, and for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment

2. Age > or = 18 years

3. European Cooperative Oncology Group performance status < or = 2

4. Written informed consent in accordance with International Conference on Harmonization -Good Clinical Practice (ICH-GCP) and local legislation

5. Recovery from Common Terminology Criteria for Adverse Events grade 2-4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapy (except alopecia)

Exclusion Criteria

1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial

2. Known hypersensitivity to the trial drugs or their excipients

3. Treatment with any other investigational drug or participation in any other interventional trial within 28 days before first administration of trial drug (BIBF 1120) or concomitantly with this trial

4. Systemic anti-cancer therapy or radiotherapy within 28 days before start of therapy or concomitantly with this trial. The restriction does not apply to steroids and bisphosphonates

5. Active infectious disease infection or HIV I/II

6. Other malignancy currently requiring another anti-cancer therapy

7. Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months

8. Known inherited predisposition to bleeding or thrombosis

9. Radiographic evidence of cavitary or necrotic tumours

10. History of clinically significant haemoptysis within the past 3 months

11. Centrally located tumours with radiographic evidence (Computed Tomography or Magnetic Resonance Imaging) of local invasion of major blood vessels

12. Absolute Neutrophil Count (ANC) less than 1.5 x 1000000000/L

13. Platelets Count (PLT) less than 100 x 1000000000/L

14. Total bilirubin > upper limit of normal (ULN)

15. Alaninaminotransferase (ALT) and/or Aspartateaminotransferase (AST) >= 1.5 x ULN (in case of liver metastases: ALT and AST >= 2.5 x ULN)

16. Serum creatinine > 1.5 mg/dl

17. Major injuries and/or surgery or bone fracture within 28 days before first administration of trial drug (BIBF 1120), or planned surgical procedures during the trial period

18. Known history of clinically relevant QT prolongation (e.g. long QT syndrome)

19. History of severe haemorrhagic or thromboembolic event in the past 6 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis)

20. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid < or = 325mg per day)

21. Active alcohol or drug abuse

22. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception during the trial

23. Pregnancy or breast-feeding

24. Patients unable to comply with the protocol

25. Uncontrolled hypertension

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1230.7.39002 Boehringer Ingelheim Investigational Site

Ancona, , Italy

1230.7.39001 Boehringer Ingelheim Investigational Site

Milan, , Italy

Countries

Italy

Other Identifiers

2008-008304-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1230.7

Identifier Type: -

Identifier Source: org_study_id