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):
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.
Drug: BIBW 2992
Drug: BIBF 1120
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
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
Drug: BIBF 1120
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Age 18 years or older.
- Life expectancy of at least three months.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Patients previously treated and with asymptomatic brain metastases are eligible
- Patients must have recovered from recent surgery.
- Active infectious disease
- Recent surgery within the last 4 weeks prior visit 1.
- Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take oral medication
- History of haemorrhagic or thrombotic events
- Significant cardiovascular diseases within
- Current peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 except due to trauma
- Untreated or symptomatic brain metastases or leptomeningeal disease.
- Treatment with an Epidermal growth Factor-receptor (EGFR)- or Heregulin Receptor 2 (HER2) inhibiting drug or antiangiogenic drug.
- Therapeutic anticoagulation.
- Female patients of childbearing potential.
- Known pre-existing interstitial lung disease
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00998296
|1239.14.3301A Boehringer Ingelheim Investigational Site
|Villejuif Cedex, France |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 19, 2009
||August 6, 2014
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 11, 2014
Molecular Mechanisms of Pharmacological Action