Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: October 19, 2009
Last updated: August 6, 2014
Last verified: August 2014

The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide dosing recommendation for subsequent phase II trials in patients with metastatic cancer.

Condition Intervention Phase
Drug: BIBW 2992
Drug: BIBF 1120
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint of this trial is the assessment of the incidence of Dose Limiting Toxicity (DLT) in the combination BIBW 2992 and BIBF 1120 when administered concomitantly and this incidence will be used to determine the Maximum Tolerated Dose (MTD) [ Time Frame: 28-day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate according to the Response Evaluation Criteria In Solid Tumours/RECIST [ Time Frame: 28-day ] [ Designated as safety issue: No ]
  • Incidence and intensity of all adverse events according to CTCAE (version 3.0). [ Time Frame: 60-months ] [ Designated as safety issue: No ]
  • Changes in safety clinical laboratory parameters evaluation [ Time Frame: 60-months ] [ Designated as safety issue: No ]
  • Determination of pharmacokinetic characteristics of BIBF1120 and BIBW 2992 [ Time Frame: 28-day ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: October 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBW 2992 + BIBF 1120
This is a phase I dose escalation clinical trial and the data obtained shall determine the MTD for the combination of BIBW 2992/BIBF 1120 in 28-day of treatment.
Drug: BIBW 2992
EGFR inhibitor
Drug: BIBF 1120
VEGF inhibitor


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Patients with confirmed histological or cytological diagnosis of advanced solid tumours and for whom no proven therapy exists or who are not amenable to established treatments.
  2. Age 18 years or older.
  3. Life expectancy of at least three months.
  4. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
  5. Patients previously treated and with asymptomatic brain metastases are eligible
  6. Patients must have recovered from recent surgery.

Exclusion criteria:

  1. Active infectious disease
  2. Recent surgery within the last 4 weeks prior visit 1.
  3. Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take oral medication
  4. History of haemorrhagic or thrombotic events
  5. Significant cardiovascular diseases within
  6. Current peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 except due to trauma
  7. Untreated or symptomatic brain metastases or leptomeningeal disease.
  8. Treatment with an Epidermal growth Factor-receptor (EGFR)- or Heregulin Receptor 2 (HER2) inhibiting drug or antiangiogenic drug.
  9. Therapeutic anticoagulation.
  10. Female patients of childbearing potential.
  11. Known pre-existing interstitial lung disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00998296

1239.14.3301A Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT00998296     History of Changes
Other Study ID Numbers: 1239.14, 2009-011321-14
Study First Received: October 19, 2009
Last Updated: August 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 23, 2014