Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01022853
First received: November 26, 2009
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: BI 6727
Drug: BIBF 1120
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 in Combination With Oral BIBF 1120 in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Determination of Maximum Tolerated Dose of BI 6727 in combination with 200 mg BIBF 1120 given twice daily [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and Intensity of drug related adverse events according to common terminology criteria for adverse events v3.0 [ Time Frame: up to 39 months ] [ Designated as safety issue: No ]
  • Incidence of Dose Limiting Toxicity [ Time Frame: up to 39 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters for BI 6727 [ Time Frame: up to 21 days from first BI 6727 dosing ] [ Designated as safety issue: No ]
  • Tumour responses according to RECIST V1.1 [ Time Frame: up to 39 months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: up to 39 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters for BIBF 1120 [ Time Frame: up to 21 days from first BI 6727 dosing ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120 and BI 6727
Finding Maximum Tolerated Dose of BI 6727 in combination with BIBF 1120
Drug: BI 6727
intravenous each 21 days
Drug: BIBF 1120
oral continuously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022853

Locations
Italy
1230.7.39002 Boehringer Ingelheim Investigational Site
Ancona, Italy
1230.7.39001 Boehringer Ingelheim Investigational Site
Milano, Italy
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01022853     History of Changes
Other Study ID Numbers: 1230.7, 2008-008304-41
Study First Received: November 26, 2009
Last Updated: November 1, 2013
Health Authority: Italy: National Institute of Health

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014