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Brief Title: Determination of Dose of Antiangiogenic Multitargeted DOVITINIB (TKI258) Plus Paclitaxel in Patients With Solid Tumors
Official Title: Phase I/II Randomized Clinical Trial of Neoadjuvant Paclitaxel Versus Priming With BIBF 1120 BIBF 1120 Followed by Plus Paclitaxel in Breast Cancer With HER-2 Negative Correlative Proteomic Studies. and Dynamic Image
Study ID: NCT01548924
Brief Summary: The investigators plan to study the determination of the dose and the combination of antiangiogenic effect of dovitinib and cytotoxic activity of weekly paclitaxel in different types of malignant tumors.
Detailed Description: This is an open label,multicenter, Phase I dose escalation study with a phase dovitinib alone for the pharmacokinetic profile and a treatment phase to evaluate the safety and tolerability of oral(po)dovitinib with paclitaxel administered intravenously (iv) (80 mg/m2 on days 1, 8, 15 and 21 every 4 weeks) in patients with malignant tumors of any histologically confirmed, not susceptible of cure, which have been treated available reference.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain
MD Anderson Cancer Centre, Madrid, , Spain
Name: Miguel Ángel Quintela, M.D.,PhD
Affiliation: CNIO
Role: STUDY_DIRECTOR
Name: Ramón Colomer, M.D.,Ph.D
Affiliation: CNIO
Role: PRINCIPAL_INVESTIGATOR