Clinical trial NCT02720926 (phase 1, status: terminated)
Conditions: colorectal cancer, gastric cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: xeloda,, oxaliplatin, tki258
SMILES: CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CN1CCN(CC1)C1=CC=C2N=C(NC2=C1)C1=C(N)C2=C(NC1=O)C=CC=C2F
Reason stopped: 
    unafavourable toxicity profile
  
Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically confirmed gastric, gastro-oesophageal or colorectal
             adenocarcinoma.

          2. The gastric or gastro-oesophageal cancer must be locally advanced unresectable or
             metastatic. Colorectal cancer must be metastatic and for which subsequent resection of
             all metastatic disease is assessed not to be feasible.

          3. Age >18 years.

          4. Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%, see
             Appendix A).

          5. Life expectancy of greater than 3 months

          6. Patients must have normal organ and marrow function as defined below:

               -  leukocytes >3,000/mcL

               -  absolute neutrophil count >1,500/microliter (mcL) TKI258/XELOX phase 1 protocol
                  version 3.3 Dated 30 November 2011 1 3

               -  platelets >100,000/mcL

               -  total bilirubin <= 1.5 x upper limit of normal (ULN)

               -  aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2.5 X
                  institutional upper limit of normal

               -  creatinine within normal institutional limits OR

               -  creatinine clearance >55 mL/min for patients with creatinine levels above
                  institutional normal.

          7. The effects of TKI258 and XELOX on the developing human fetus are unknown. For this
             reason, women of child-bearing potential and men must agree to use adequate
             contraception (hormonal or barrier method of birth control; abstinence) prior to study
             entry and for the duration of study participation. Should a woman become pregnant or
             suspect she is pregnant while participating in this study, she should inform her
             treating physician immediately.

          8. Baseline left ventricular ejection fraction (LVEF) >= 50%

          9. Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          1. Patients are not considered to have a "currently active" malignancy if they have
             TKI258/XELOX phase 1 protocol version 3.3 Dated 30 November 2011 1 4 completed therapy
             and are considered to have a less than 30% risk of relapse.

          2. Pregnant women are excluded from this study because of the potential for teratogenic
             or abortifacient effects. Because there is an unknown but potential risk for adverse
             events in nursing infants secondary to treatment of the mother with TKI258 or XELOX,
             breastfeeding should be discontinued if the mother is treated with TKI258 or XELOX.

          3. Patients with prior history of transient ischemia attack or cerebrovascular disease or
             prior history of ischemia heart disease or myocardia infarction and 2 or more risk
             factors: ever smoker with > 30 packs per year exposure or on medication for diabetes
             mellitus or hypertension or hyperlipidemia.

          4. In addition for the Beginning at dose expansion cohort, the following exclusion
             criteria apply:

               -  Patients who are not agreeable for collection of tumor tissue for correlative
                  studies

               -  Patients from whom tumor tissue for correlative studies cannot be safely
                  obtained.