12 results
Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…
The purpose of this study is to find out how well JNJ-56021927 works when it is given along with abiraterone acetate and prednisone to treat prostate cancer. The safety of JNJ-56021927 when used with abiraterone acetate will also be studied. How…
Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…
In oral FXa inhibitor-treated patients with acute intracranial bleeding, the objectives of this study are as follows:Primary Efficacy Objective:• To evaluate the effect of andexanet versus usual care on the rate of effective hemostasis.Secondary…
To prospectively explore the feasibility safety, tolerability, preliminary efficacy, costs, and pharmacokinetic profile of repetitive ePIPAC-OX as a palliative monotherapy for isolated unresectable colorectal PM under controlled circumstances.
primaryTo assess the safety and tolerability of multiple, once-daily oral doses of RDN-929 over 28 days in healthy older adult subjects and early symptomatic AD subjects.secondaryTo assess the plasma and CSF pharmacokinetics (PK) of RDN-929 in…
Primary Objectives:-To evaluate if the treatment of Low Risk HB can be reduced (Group B1)-To compare different induction treatment regimens for Intermediate risk HB (Group C)-To compare different post induction treatment regimens for High Risk HB (…
To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
Primary objective:To determine the percentage of the patients that achieve optimal 5-FU exposure within two dose cycles of 5-FU, which is defined by an AUC target of 5-FU between 20 and 30 mg h/L or dose limiting toxicity.Secondary objectives:-To…
Primary Objective: - To establish the population range (24-h AUC) of high-dose infusional 5-FU in patients with locally advanced, resectable gastric or gastro-esophageal junction cancer treated with perioperative FLOT.Secondary objectives: - To…
The aim of this study is to prove feasibility of HAIP chemotherapy (floxuridine) in combination with standard systemic chemotherapy consisting of FOLFOX or FOLFIRI.