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Randomized Multicenter Trial With SU11248 Evaluating Dosage,Tolerability,Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor

NCT00543049 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2014-03-07

No results posted yet for this study

Summary

Ovarian cancer is most often recognized in advanced clinical state, the initial therapeutic strategies consist of a platinum containing chemotherapy subsequent to primary surgery. Although initially responsive to platinum-paclitaxel containing chemotherapy, a significant number of patients will show tumor progression during first line chemotherapy or relapse within six months after completion of first line chemotherapy, therefore being characterized as chemotherapy resistant. Any second line chemotherapy will result in approximately 10% of overall response, underlining the poor prognosis for these patients with an estimated median overall survival of 20 weeks.

In addition to conventional chemotherapeutics, so called small molecules are of high interest to establish new strategies in chemotherapy-refractory ovarian cancer (and in the long run first line chemotherapy). SU11248 is a polytargeting tyrosine kinase inhibitor.

SU11248 has demonstrated clinical efficacy in kidney cancer and GIST, further clinical trials have been initiated in other tumor entities. Growth pattern and biological targets present in ovarian cancer indicate that SU11248 might be a promising compound for the treatment of ovarian cancer. Especially, VEGFR, PDGFR and c-kit are specific targets for SU11248, which are expressed in ovarian cancer. The different targets of SU11248 provide a potential advantage of this compound compared to single-target molecules in chemotherapy-refractory ovarian cancer.

Conditions

  • Platinum Refractory Epithelial Ovarian Cancer
  • Primary Cancer of the Peritoneum
  • Cancer of the Fallopian Tube

Interventions

DRUG

Sunitinib

Sunitinib, oral, 50mg once daily, 28 days then paused for 14 days, for up to one year

DRUG

SUNITINIB

Sunitinib, oral, 37,5 mg once daily continuously, up to one year

Sponsors & Collaborators

  • Philipps University Marburg

    collaborator OTHER

  • HSK Reasearch GmbH Wiesbaden

    collaborator UNKNOWN

  • AGO Study Group

    lead OTHER

Principal Investigators

  • Uwe Wagner, MD, PhD · Universitätsklinikum Gießen u. Marburg, Klinik f. Gynäkologie, Gyn. Endokrinologie u. Onkologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-06-30

Countries

  • Germany

Study Locations

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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 NCT00543049 on ClinicalTrials.gov