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An Open Label Phase I Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer - Stage IV

Phase 1
71 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

An Open Label Phase I Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer - Stage IV

Patients older than 70 years could be enrolled in this clinical trial. The trial is being
carried out in two trial centres in Germany.

For the planned sample size it is assumed that two different dosage groups are needed with 6
patients on each dosage group with the option to deescalate the first dosage. Altogether
this leads to an estimated sample size of maximal 18 patients.

- Duration of treatment/patient: up to 6 month

- Follow Up: at least 6 month

Inclusion Criteria:

- Histological confirmed Non-Small-Cell lung cancer (NSCLC)

- Tumor stage IV (UICC 7th Version)

- ECOG <2

- Age > 70 years

- No previous chemotherapy for stage IV NSCLC (UICC 7th Version)

- Adjuvant or neoadjuvant chemotherapy for NSCLC must be completed at least one year
prior to study enrolment (from end of chemotherapy)

- Patients with prior radiation therapy may be eligible for this study if they meet the
following guidelines:

- Previous radiation therapy is allowed to <25% of the bone marrow (Cristy and
Eckerman 1987), but should have been limited and must not have included whole
pelvis radiation.

- Patients must have recovered from the toxic effects of the treatment prior to
study enrolment (except for alopecia).

- Prior thoracic radiotherapy must be completed 30 days before study enrolment.

- Lesions that have been irradiated cannot be included as sites of measurable
disease unless clear tumour progression has been documented in these lesions
since the end of radiation therapy.

- Palliative extrathoracic radiotherapy to pre-existing lesions may continue on
study; however, these lesions may not be included as sites of measurable

- Adequate haematological laboratory parameters:

- Haemoglobin ≥9 g/dl

- WBC ≥3.000/µl

- Platelets ≥ 100.000/µl

- Neutrophil count > 1,500/µl

- Adequate renal laboratory parameters

- Creatinine ≤1,9 mg/dl

- Creatinine Clearance > 45 ml/min

- Adequate hepatic function

- Total bilirubin within normal range

- Total bilirubin < 1.5 x ULN (patients with liver metastasis)

- ALT < 1.5 x ULN

- ALT < 2.5 x ULN (patients with liver metastasis)

- AST < 1.5 x ULN

- AST < 2.5 x ULN (patients with liver metastasis)

- Alk. phosphatase < 3 x ULN

- LDH < 5 x ULN ULN = Upper Limit Of Normal (ULN)

- Other lab parameters:

- Proteinuria < CTCAE grade 2

- Prothrombin time and/or partial thromboplastin time < 50 % deviation from normal

- Informed consent, personally signed and dated to participate in the study

- Male patients enrolled in this trial must use adequate barrier birth control measures
during the course of treatment and for at least 3 months after the last
administration of study therapy

- Life expectancy at least 3 months

Exclusion Criteria:

- Any severe concomitant condition which makes it undesirable for the patient to
participate in the study or which could jeopardise compliance with the protocol

- Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial,
antifungal) therapy

- Serious, non-healing wound, ulcer or bone fracture or major injuries and/or surgery
within 4 weeks of trial inclusion, or planned surgical procedures during the trial

- Investigational drug therapy outside of this trial during or within 4 weeks of study

- Known hypersensitivity to the trial drugs or their excipients.

- History of other malignancies in the last 5 years, in particular those which could
affect compliance with the protocol or interpretation of results. Patients with
adequately treated basal or squamous cell skin cancer are generally eligible.

- Serious concomitant disease, especially those that would limit compliance with trial
requirements or which are considered relevant for the evaluation of the efficacy or
safety of the trial drug, such as neurologic, psychiatric, infectious disease or
active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may
increase the risk associated with trial participation or trial drug administration,
and in the judgment of the investigator would make the patient inappropriate for
entry into the trial.

- Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina,
history of infarction within past 9 months, congestive heart failure >NYHA II)

- Known inherited predisposition to bleeds or to thrombosis.

- Patient with brain metastases that are symptomatic and/or require therapy.

- Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed
for maintenance of an indwelling intravenous device) or antiplatelet therapy (except
for chronic low-dose therapy with acetylsalicylic acid ≤ 325mg per day)

- History of major thrombotic events or clinically relevant major bleeding event in the
past 6 months (excluding central venous catheter thrombosis and peripheral deep vein
thrombosis below the joint space of the knee)

- Current peripheral neuropathy ≥ CTCAE grade 2 except due to trauma

- Gastrointestinal disorders or abnormalities that would interfere with absorption of
the study drug

- Active alcohol or drug abuse.

- Men who are sexually active and unwilling to use a medically acceptable method of

- Leptomeningeal disease

- Radiographic evidence of cavitary or necrotic tumours

- Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of
major blood vessels

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To investigate the maximum tolerated dose of BIBF 1120

Outcome Time Frame:

Cycle 1 day 1, day 8, day 15; Cycle 2 day 1, day 8, day 15; Cycle 3 day 1, day 8, day 15; Cycle 4 day 1, day 8, day 15; day 84

Safety Issue:


Principal Investigator

Prof. Dr. Martin Wolf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum Kassel GmbH, D-34125 Kassel


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Lung Cancer
  • NSCLC Stage IV
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms