Phase Ib Study of Gemcitabine Plus Cisplatin or Carboplatin Plus Dovitinib in Patients With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Solid Tumors, Bladder Cancer

In brief

This is a phase Ib dose escalation study of dovitinib given in combination with either gemcitabine plus cisplatin or carboplatin in patients with advanced solid tumors. Patients with advanced solid tumors, for whom treatment with gemcitabine plus cisplatin or carboplatin would otherwise be warranted, will be enrolled. The dose of dovitinib will be escalated in successive cohorts using standard "3+3" dose escalation rules. Patients will continue treatment, in the absence of prohibitive toxicity, until disease progression. The study will define the recommended phase II dose of these combination regimens.

Key facts

Study ID

NCT01496534

Run by

Matthew Galsky

People needed

14

Starts

2012-01-01

Expected to finish

2013-09-01

Last updated by the study team

2013-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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