⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Randomized Multicenter Trial With SU11248 Evaluating Dosage,Tolerability,Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: Phase II Trial in Platinum-refractory Ovarian Cancer: A Randomized Multicenter Trial With SU11248 to Evaluate Dosage, Tolerability, Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor Monotherapy

Study ID: NCT00543049

Interventions

Sunitinib
SUNITINIB

Study Description

Brief 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.

Detailed Description: This study in patients with ovarian cancer refractory to platinum based chemotherapy is designed as a randomized, 2-schedule and dose-level, open-label, multicenter phase II study to select the better dose and schedule arm for further investigation. 72 patients will be randomized in a 1:1 ratio to receive oral SU11248 therapy either 37.5 mg/day continuously or 50mg/day for 4 weeks followed by 14 days off. Patients will get outpatients treatment. At screening the patients' eligibility will be assessed, their baseline and demographic characteristics obtained, and the baseline values for the effect variables collected. Patients with measurable lesions as well as non-measurable disease will be included into this trial. Measurable lesion will be documented by CT or MRI scan and CA-125 values, non-measurable lesions will be monitored by analysis of CA°125 levels. The patients' safety will be monitored during and up to 30 days after termination of SU11248 therapy. In patients with measurable lesions at baseline, the (post)-treatment values for effect according to the RECIST criteria will be collected as shown in table 6. In case of CR or PR, a confirmatory CT or MRI scan is required after an interval of at least four weeks. Antitumor effects according to CA°125 levels will be determined in the same time intervals and, in addition, 28 days after last SU11248 application in patients with CA°125 response according to GCIG guidelines during therapy. For post study follow-up, patients and/or their physicians will be contacted via phone for overall survival and TTP (including the method of diagnosis and additional treatment) every 2 months for their life time.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Malterser-Krankenhaus Bonn-Rhein/Sieg, Frauenklinik, Bonn, , Germany

Klinikum Bremen-Mitte gGmbH, Frauenklinik, Bremen, , Germany

Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik fßr Frauenheilkunde und Geburtshilfe, Dresden, , Germany

Universitätsklinikum, Universitätsfrauenklinik, Essen, , Germany

Klinikum der JWG Universität Frankfurt, Universitätsfrauenklinik, Frankfurt am Main, , Germany

Universitätsklinikum Freiburg, Department Universitäts-Frauenklinik, Freiburg, , Germany

Klinikum der Ernst-Moritz-Universität, Klinik u. Poliklinik fßr Gyn. - u. Geb.Hilfe, Greifswald, , Germany

Med. Hochschule Hannover, Frauenklinik, Hannover, , Germany

St. Vincentius Kliniken AG, Frauenklinik, Karlsruhe, , Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe, Kiel, , Germany

Otto-von-Guericke-Universität, Klinik fßr Frauenheilkunde und Geburtshilfe, Magdeburg, , Germany

Universitätsklinikum Gießen u. Marburg, Standort Marburg, Klinik f. Gynäkologie, Gyn. Endokrinologie u. Onkologie, Marburg, , Germany

Elblandkliniken Meißen-Radebeul GmbH, Gynäkologie, Radebeul, , Germany

Universitätsklinikum Tßbingen, Frauenklinik, Tßbingen, , Germany

Universitätsklinikum, Universitätsfrauenklinik, Ulm, , Germany

Dr. Horst Schmidt Kliniken GmbH, Klinik f. Gynäkologie u. Gyn. Onkologie, Wiesbaden, , Germany

Contact Details

Name: Uwe Wagner, MD, PhD

Affiliation: Universitätsklinikum Gießen u. Marburg, Klinik f. Gynäkologie, Gyn. Endokrinologie u. Onkologie

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: