NCT01548924

Determination of Dose of Antiangiogenic Multitargeted DOVITINIB (TKI258) Plus Paclitaxel in Patients With Solid Tumors

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Dovitinib	Orally Dovitinib once a day and a five-day regimen of administration and then two days resting, in cycles of 28 days.
DRUG	Dovitinib + Paclitaxel	* Paclitaxel (80 mg/m2) : 1, 8, 15 and 21. * Dovitinib (100 mg, 200 mg,300 mg, 400 mg or500 mg; it depends on the level of the Phase 1 study in each patient): five days of treatment / two days off. Each cycle will last for 28 days.

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-02-01
• Completion: 2013-08-01
• First posted: 2012-03-08
• Last updated: 2020-04-17

Locations

3 sites across 1 country: Spain