Spots Global Cancer Trial Database for Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer
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Trial Identification
Brief Title: Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer
Official Title: Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer
Study ID: NCT02993094
Conditions
Study Description
Brief Summary: This is an open-label phase I/II study for patients with advanced (locally advanced inoperable or metastatic) triple-negative breast cancer progressing after first-line therapy receiving ixazomib on days 1, 8, and 15 in combination with carboplatin on days 1, 8, and 15. Cycles will be repeated every four weeks.
Detailed Description: The phase I part of this study uses an alternate dose escalation accelerated titration design. In the accelerated dose-escalation phase a single-patient cohort per dose level will be enrolled, until one dose limiting toxicity (DLT) or 2 moderate toxicities are observed during cycle 1, or until dose level 4 is reached. At this dose level the cohort is expanded to three patients and dose escalation reverts to a conventional 3+3 escalation design. DLTs are defined as inability to deliver the drug combination of ixazomib and carboplatin due to drug related toxicity. The maximum-administered dose (MAD) is defined as the dose at which DLT occur in at least two of six patients treated at that dose level. The dose just below the MAD is considered the maximum-tolerated dose (MTD), providing that DLT is observed in fewer than two of six treated patients (or fewer than one third if more than six patients will be treated) at that dose level. Determination of MAD and MTD is based on DLT observed during the first treatment cycle. Phase II: After establishing MTD in phase I, accrual continues to evaluate the efficacy and safety of the combination. A total of 41 patients will be included (patients enrolled in the phase I part within the conventional dose escalation phase at the dose level considered as the MTD may be included). All subjects will continue on study drugs until disease progression, unacceptable toxicity or treatment discontinuation for any other reason.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Klinikum Kreuzschwestern Wels GmbH, Wels, OberĂśsterreich, Austria
Universitätsklinik fßr Innere Medizin Graz, Graz, Steiermark, Austria
Universitätsklinik fßr Frauenheilkunde Innsbruck, Innsbruck, Tirol, Austria
Landeskrankenhaus Feldkirch, Innere Med. II, Interne E, Feldkirch, Vorarlberg, Austria
UK Graz: Universitätsklinik fßr Frauenheilkunde und Geburtshilfe, Klinische Abteilung fßr Gynäkologie, Graz, , Austria
LKH Hochsteiermark: Department fßr Hämato-Onkologie, Leoben, , Austria
BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie, Linz, , Austria
KUK Linz: Klinik fßr Interne 3 - Schwerpunkt Hämatologie und Onkologie, Linz, , Austria
PMU Salzburg: Universitätsklinik fßr Innere Medizin III, Salzburg, , Austria
Landeskrankenhaus Steyr, Innere Medizin II Onkologie, Steyr, , Austria
AKH Wien Universitätsklinik fßr Frauenheilkunde: Klin. Abt. f. Allg. Gynäkologie und gynäkologische Onkologie, Vienna, , Austria
LK Wiener Neustadt: Innere Medizin, Hämatologie und internistische Onkologie, Wiener Neustadt, , Austria
Contact Details
Name: Richard Greil, MD
Affiliation: PMU Salzburg: Universitätsklinik fßr Innere Medizin III
Role: STUDY_DIRECTOR
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