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

NCT01548924 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-04-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hospital Universitario de Fuenlabrada

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Hospital Universitari de Bellvitge

    collaborator OTHER

  • Centro Nacional de Investigaciones Oncologicas CARLOS III

    lead OTHER

Principal Investigators

  • Miguel Ángel Quintela, M.D.,PhD · CNIO

  • Ramón Colomer, M.D.,Ph.D · CNIO

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-02-28
Completion
2013-08-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01548924 on ClinicalTrials.gov