Clinical trial · Interventional
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
NCT00998296CI-TRIAL-00018887completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIBF 1120 | Drug | Nintedanib | ALIAS |
| BIBW 2992 | Drug | Afatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BIBW 2992 + BIBF 1120
- description
- 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.
- interventionNames
- Drug: BIBW 2992
- Drug: BIBF 1120
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
- timeFrame
- first treatment cycle, up to 28 days
- description
- Maximum tolerated dose (MTD) of nintedanib and afatinib based on the Percentage of participants experienced dose limiting toxicities during the dose escalation phase.
Secondary outcomes (9)
- measure
- Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBahleda R, Hollebecque A, Varga A, Gazzah A, Massard C, Deutsch E, Amellal N, Farace F, Ould-Kaci M, Roux F, Marzin K, Soria JC. Phase I study of afatinib combined with nintedanib in patients with advanced solid tumours. Br J Cancer. 2015 Nov 17;113(10):1413-20. doi: 10.1038/bjc.2015.374. Epub 2015 Oct 29. PMID 26512876