Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01496534
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01496534
Study Brief:
Protocol Section:
NCT01496534