The MTD was defined as the highest dose studied for which the incidence of DLTs was 0/3 or less than 2/6 patients during the first treatment course.

Treated set (Patients from the dose escalation part that were not replaced for MTD determination)

TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.

Treated set, only phase II participants.

TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.

Treated set, Only phase II participants

Incidence and worst intensity (severity) of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).

Treated set

Number of patients with dose limiting toxicity are presented

Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).

Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.

95% Confidence Interval presented below are computed by Clopper and Pearson method.

Treated set, only phase II participants.

PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.

Treated set, only phase II participants.

Overall survival was defined as the duration from date of randomisation to the date of death.

Treated set, include only phase II participants

AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of Nintedanib

Detailed time points of sampling are:

Phase I and selected phase II patients in the Nintedanib arm:

Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.

Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.

AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of BIBF 1202 (metabolite of Nintedanib).

Detailed time points of sampling are:

Phase I and selected phase II patients in the Nintedanib arm:

Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.

Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.

AUC0-12,ss,norm of BIBF 1202 glucuronide (Metabolite of Nintedanib):

Detailed time points of sampling are:

Phase I and selected phase II patients in the Nintedanib arm:

Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.

Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.

Cmax,ss,norm (maximum concentration of the Nintedanib in plasma at steady state, normalised values).

Detailed time points of sampling are:

Phase I and selected phase II patients in the Nintedanib arm:

Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.

Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.

Cmax,ss,norm (maximum concentration of the BIBF 1202 in plasma at steady state, normalised values).

Detailed time points of sampling are:

Phase I and selected phase II patients in the Nintedanib arm:

Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.

Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.

Cmax,ss,norm (maximum concentration of the BIBF 1202 glucuronide in plasma at steady state, normalised values).

Detailed time points of sampling are:

Phase I and selected phase II patients in the Nintedanib arm:

Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.

Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.

fe0-12,ss (fraction excreted in urine between 0 and 12 hours at steady state) for Nintedanib.

The reported value corresponds to the percentage of administered dose.

Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.