15 results
2.1 Primary objectiveTo assess the rate of no progression (NPR) at 8 weeks following treatment with the combination of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible EGFR TKI*s (gefitinib or…
Primary* To determine the maximum tolerated dose or recommended phase 2 dose of oral BYL719 as single agent and in combination with fulvestrantSecondary* To assess the overall safety and tolerability of BYL719 as single agent and in combination with…
The aim of this study is to quantify residual ER binding sites during fulvestrant therapy, compared to the tracer uptake prior to fulvestrant therapy.
Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…
To investigate prospectively how the "TAMRO-profile" performs in a pre-operative treatment setting. In addition we can examine whether the profile is specific for tamoxifen or is predictive for endocrine resistance in general. Also the…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
Primary: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus, HDM201, QBM076 or panobinostat and to identify recommended doses and schedules for future studies.Secondary: To characterize changes in the immune…
To assess the safety and feasibility of HIPEC and CS in Western patients with peritoneal metastases of gastric cancer, in terms of morbidity and mortality. Secondary objective is to determine the effect on survival and recurrence.
The proposed Study J2G-MC-JZJC (hereafter referred to as JZJC) will evaluate selpercatinib in comparison to platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab in patients with locally advanced or…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
Evaluate the efficacy of the ER-antagonist Fulvestrant in women with estrogen receptor positive (ER+) low grade gynecological cancers
Primary ObjectiveTo evaluate the antitumor activity of tucatinib given in combination with trastuzumab in subjects with previously treated, locally-advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) overexpressing/…
Primary: To compare PFS between ribociclib plus fulvestrant to fulvestrant monotherapy (plus placebo) among men and postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for…