Clinical trial NCT01466647 (phase 1, status: completed)
Conditions: non small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: axl1717
SMILES: COC1=CC(=CC(OC)=C1OC)[C@H]1[C@H]2[C@H](COC2=O)[C@@H](O)C2=CC3=C(OCO3)C=C12
Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age.

          2. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic
             squamous non-small-cell lung cancer (stage IIIB or IV) and scheduled for treatment
             with cytotoxic chemotherapy (Gemcitabine HCL/Carboplatin)

          3. Preserved major organ functions, i.e:

               -  B-Leukocyte count ≥ 3.0 x 109/L

               -  B-Neutrophil count ≥ 1.5 x 109/L

               -  B-Platelet count ≥ 75 x109/L

               -  B-Haemoglobin ≥ 100 g/L (transfusions are allowed)

               -  P-Total bilirubin level ≤ 1.5 times the upper institutional limit of the "normal"
                  (i.e. reference)range

               -  P-ASAT or P-ALAT ≤ 2.5 times upper institutional limit of the "normal" range, ≤5
                  times if liver metastases have been documented

               -  P-Creatinine ≤ 1.5 times upper institutional limit of the "normal" range

               -  12-lead ECG with normal tracings; or clinically nonsignificant changes that did
                  not require medical intervention

          4. Signed written informed consent.

        Exclusion Criteria:

          -  The presence of any of the following criteria will exclude the patient from
             participating in the study:

               -  Ongoing infection or other major recent or ongoing disease that, according to the
                  investigator, poses an unacceptable risk to the patient

               -  Grade 3 or higher constipation within the past 28 days or grade 2 constipation
                  within the past 14 days before randomization. (Patients with grade 2 constipation
                  within the past 14 days could be re-screened if constipation decreases to ≤ grade
                  1 with optimal management of constipation.)

               -  Known malignancy in Central Nervous System (CNS)

               -  Disease and dementia and neuropathy grade more than 1

               -  Other active malignancy during the previous 3 years

               -  Major surgical procedure within 4 weeks

               -  Prior anti-tumor therapy apart from radiation therapy

               -  Women Of Child Bearing Potential (WOCBP) - For purposes of this study, WOCBP
                  include any female who has experienced menarche and who is not postmenopausal.
                  Post menopause is defined as: Amenorrhea ≥ 12 consecutive months without another
                  cause

               -  Pregnancy or lactation

               -  Current participation in any other interventional clinical trial

               -  Performance status > ECOG 2 after optimization of analgesics

               -  Life expectancy less than 3 months

               -  Contraindications to the investigational product, e.g. known or suspected
                  hypersensitivity.

               -  Lack of suitability for participation in the trial, for any reason, as judged by
                  the Investigator.