Clinical trial NCT01496534 (phase 1, status: terminated)
Conditions: solid tumors, bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: cisplatin, carboplatin
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    toxicity of combination of medications
  
Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and HIPAA authorization for release of personal health
             information.

          -  Age ≥ 18 years at the time of consent.

          -  Karnofsky Performance Status of ≥ 70%.

          -  Advanced/metastatic solid tumor for which treatment with gemcitabine plus carboplatin
             or gemcitabine plus cisplatin would otherwise be warranted.

          -  Prior treatment with chemotherapy is permitted. Patients must not have received more
             than three prior chemotherapeutic regimens.

          -  Adequate organ function as determined by the following laboratory values:

               -  Hemoglobin (Hgb) ≥ 9 g/dL

               -  Platelets ≥ 100 x 109/L

               -  Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

               -  Creatinine of ≤ 1.5 OR Calculated creatinine clearance of ≥ 60 cc/min for the
                  cisplatin cohort.

        Calculated creatinine clearance of ≥ 30 cc/min for the carboplatin cohort.

          -  Bilirubin ≤ 1.5 x ULN

          -  Aspartate aminotransferase (AST, SGOT) ≤ 1.5 ULN

          -  Alanine Aminotransferase (ALT, SGPT) < 1.5 ULN

          -  INR ≤ 1.5 and a PTT within normal limits

          -  LVEF assessed by 2-D echocardiogram (ECHO) > 50% or lower limit of normal or multiple
             gated acquisition scan (MUGA) > 45% or lower limit of normal

        Exclusion Criteria:

          -  Prior treatment with more than three prior chemotherapy regimens.

          -  Has had major surgery within 30 days of starting the study treatment

          -  Have active CNS metastases.

          -  No treatment with any investigational agent within 30 days prior to being registered
             for protocol therapy.

          -  Prior cancer treatment must be completed at least 30 days prior to being registered
             for protocol therapy and the subject must have recovered from the acute toxic effects
             of the regimen.

          -  Prior radiation therapy must be completed at least 30 days prior to being registered
             for protocol therapy.

          -  Pregnant or breastfeeding.

          -  Clinically significant infections as judged by the treating investigator.

          -  Impaired cardiac function or clinically significant cardiac diseases

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea,
             vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

          -  Patients who are currently receiving anticoagulation treatment with therapeutic doses
             of warfarin

          -  Women of child-bearing potential, who are biologically able to conceive, not employing
             two forms of highly effective contraception.

          -  Fertile males not willing to use contraception