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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00998296
First received: October 19, 2009
Last updated: August 6, 2014
Last verified: August 2014

October 19, 2009
August 6, 2014
October 2009
July 2014   (final data collection date for primary outcome measure)
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 ]
The primary endpoint of this trial is the assessment of the incidence of DLTs in the combination BIBW 2992 and BIBF 1120 when administered concomitantly, and this incidence will be used to determine the MTD. [ Time Frame: 28-day ]
Complete list of historical versions of study NCT00998296 on ClinicalTrials.gov Archive Site
  • 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 ]
The overall response rate according to the RECIST Incidence and intensity of all adverse events according to CTCAE (version 3.0). Safety clinical laboratory parameters evaluation The circulating tumor cells (CTC) [ Time Frame: 28-day ]
Not Provided
Not Provided
 
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • Drug: BIBW 2992
    EGFR inhibitor
  • Drug: BIBF 1120
    VEGF inhibitor
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.
Interventions:
  • Drug: BIBW 2992
  • Drug: BIBF 1120
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00998296
1239.14, 2009-011321-14
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP