7053 Background: Elderly unfit patients with AML have a dismal prognosis. The oral multikinase inhibitor BIBF1120 (nintedanib) was reported to exert growth inhibitory and proapoptotic effects in myeloid cells, especially when used in combination with cytarabine (AraC). Methods: This phase I study evaluated the combination of AraC (20mg subcutaneously twice daily on days 1-10 every 28 days) with BIBF1120 in 3 predefined dose levels (DL: 100, 150, and 200mg orally twice daily) in elderly patients with AML ineligible for intensive treatment or treatment with 5-Aza in a 3+3 design. Protocol-specific definitions: Therapy-related cytopenias constituted no adverse events (AE). AEs of special interest (AESI) were elevation of AST and/or ALT >3x upper level of normal (ULN) combined with an elevation of bilirubin >2x ULN, and any hollow organ perforation occurring after the first intake of study medication. DLT was defined as non-hematological SAR CTC grade ≥IV with possible or definite relationship to BIBF1120 occurring during or up to 28 days after the first cycle. Results: Between April 2012 and October 2013, 13 patients were enrolled into the phase I part of this trial (DL1: 3 patients, DL2: 4 patients, DL3: 6 patients). 1 patient in DL2 did not receive study medication and was replaced. Median age was 73 (range: 62 – 86) years. Disease status was untreated (4 patients), relapsed (5) and refractory (4) AML. Cytogenetic risk was favorable (1 patient), intermediate (5), unfavorable (6) or missing (1). 8 SAEs occurred (DL1: 1, DL2: 3, DL3: 5). All of the 3 SARs were neutropenic fever grade 3 (DL2: 1, DL3: 2). 2 SUSARs were observed, 1 fatal hypercalcemia (DL2) and 1 fatal GI tract infection (DL3). No AESI were observed. The phase II recommended dose (P2RD) was set as DL3 by the DMC. 2 patients with relapsed AML responded (1 CR, 1 CRi). Bone marrow blast reductions without fulfilling the PR criteria were observed in 3 patients. One-year survival from start of therapy was 46% after a median follow-up of 308 days. Conclusions: BIBF1120 combined with LD-AraC shows a favorable safety profile. Preliminary survival data are promising. Continuation of this trial with a P2RD of 2 x 200mg in a randomised phase II is planned. Clinical trial information: NCT01488344.