Determination of Dose of Antiangiogenic Multitargeted DOVITINIB (TKI258) Plus Paclitaxel in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01548924|
Recruitment Status : Terminated (Drug toxicity)
First Posted : March 8, 2012
Last Update Posted : January 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Dovitinib Drug: Dovitinib + Paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||August 2013|
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.
- Maximum tolerated dose (MTD) [ Time Frame: After priming phase (7 days) ]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 ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548924
|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|