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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: BIBF 1120; Drug: BIBW 2992

Study type: Interventional

Funder types: Industry

Identifiers

NCT00998296

1239.14

2009-011321-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

BIBW 2992 + BIBF 1120

Experimental group

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.

Treatment:

Drug: BIBF 1120

Drug: BIBW 2992