Determination of Dose of Antiangiogenic Multitargeted DOVITINIB (TKI258) Plus Paclitaxel in Patients With Solid Tumors
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Maximum tolerated dose (MTD) [ Time Frame: After priming phase (7 days) ] [ Designated as safety issue: Yes ]Determine the maximum tolerated dose (MTD), the recommended dose for Phase 2 and the safety and tolerability in combination with paclitaxel dovitinib weekly
- Pharmacokinetic interactions between paclitaxel and dovitinib [ Time Frame: Baseline and end oftreatment phase, an espected average of 16 weeks ] [ Designated as safety issue: Yes ]
To evaluate the pharmacokinetic interactions between paclitaxel and dovitinib. Establish the sampling circuit and molecular diagnostic procedures for future expansion cohort at the recommended dose for Phase 2, focusing on patients with amplifications or mutations of drug targets.
Other criteria for safety assessment will be the number of cycles and dose intensity of each component of the treatment regimen, changes in vital signs and results of laboratory tests during and after administration of paclitaxel and dovitinib
|Study Start Date:||April 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Priming Phase
The study treatment begins with the period of seven days of priming Phase, which is administered in monoterapi dovitinib
Orally Dovitinib once a day and a five-day regimen of administration and then two days resting, in cycles of 28 days.
Other Name: TKI-258
Experimental: Treatment Phase
The phase of treatment with two drugs (paclitaxel dovitinib more fixed dose of 80 mg/m2 per week) will begin after a washout period of seven days after the priming phase.
Drug: Dovitinib + Paclitaxel
Each cycle will last for 28 days.
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.
|Hospital Universitario de Bellvitge|
|Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Hospital Universitario de Fuenlabrada|
|Fuenlabrada, Madrid, Spain, 28049|
|MD Anderson Cancer Centre|
|Study Director:||Miguel Ángel Quintela, M.D.,PhD||CNIO|
|Principal Investigator:||Ramón Colomer, M.D.,Ph.D||CNIO|