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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase I of BIBW 2992/BIBF 1120 Combination Therapy in Solid Tumors

NCT00730821

Neoplasms

COMPLETED PHASE1

An Dose Escalation Study of Treatment With BIBF 1120 in Patients With Advanced Solid Tumours

NCT02182206

Tumors

COMPLETED PHASE1

Dose Escalation Study of BIBW 2992 in Patients With Advanced Solid Tumors

NCT02171663

Neoplasms

COMPLETED PHASE1

Dose Escalation Trial of BIBW 2992 Administration in Combination With Docetaxel in Patients With Advanced Solid Tumors

NCT02171741

Neoplasms

COMPLETED PHASE1

Dose Escalation Study of Continuous Once-daily Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors

NCT02171728

Neoplasms

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

BIBW 2992

Intervention Type DRUG

EGFR inhibitor

BIBF 1120

Intervention Type DRUG

VEGF inhibitor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BIBW 2992

EGFR inhibitor

Intervention Type DRUG

BIBF 1120

VEGF inhibitor

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No