An 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 (VENUS-2)

Sponsor
Aktion Bronchialkarzinom e.V.
Study ID
NCT01683682
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
71 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BIBF 1120 — DRUG
    2 x 150 mg capsules, oral, daily (Start dose)
  • Vinorelbine — DRUG
    25 mg/m2 i.v. on day 1 and 8 (three-week cycle)
  • Carboplatin — DRUG
    AUC 5 i.v. on day 1 (three-week cycle)

Study Details

To investigate the maximum tolerated dose of BIBF 1120 and safety in escalating doses administered with Vinorelbine i.v. and Carboplatin i.v. in elderly patients with advanced Non-Small Lung Cancer (Stage IV).

Key Dates

Start date
Apr 30, 2013
Status verified
Jan 2015
Primary completion
Jan 31, 2015

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BIBF 1120, Vinorelbine, Carboplatin
    To determine the 'Maximum Toleraetd Dose', dose escalation for BIBF 1120 will be conducted following the 3 + 3 design. A cohort of three patients will be treated at the starting dose level 150mg bid and observed until the end of the first cycle. Under certain conditions the dose level will be escalated to 200mg bid in a second cohort.

Primary Outcome Measure

To investigate the maximum tolerated dose of BIBF 1120 [ 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 ]

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