14 resultados
1. Test population: Patients with stage III gastric cancer confirmed by postoperative pathology
2. Sample size calculation: single arm design was used in this study, and the main outcome was progression free survival. In this study, PD-L1 + CPS ≥ 10% / MSI-H + / EB +, the sample size was estimated
PRIMARY OBJECTIVES:
I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy.
SECONDARY OBJECTIVES:
I. To assess
This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and safety of AryoTrust (Aryogen Trastuzumab) in comparison to Herceptin® (Genentech/Roche) in patients with Human
Inclusion criteria:
1. Patients with stage IV breast cancer with metastases demonstrated by appropriate imaging techniques
2. Histologically or cytologically confirmed tumor
3. Age of 18 years or more
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
5. Patients have failed,
OUTLINE: This is a multi-center study.
INVESTIGATIONAL TREATMENT:
- bicalutamide - 150mg po daily D1 - D28 (Cycle = 28 days)
- ribociclib po daily D1 - D21 of 28 day cycle
PHASE I SAFETY RUN-IN COHORT:
The maximum tolerated dose (MTD) of bicalutamide in combination with ribociclib will be determined
The FG-3019 treatment will be administered over a 28-day cycle:
- Dose: 35 mg/kg
- Route: IV over one hour following completion of gemcitabine infusion
- Schedule:
- Days 1, 8, and 15
- Please note that Day 8 infusion will on be completed during the first treatment cycle
On Drug Evaluation
The
1. Introduction to investigational treatment(s) and other study treatment(s)
1.1 Overview of gemcitabine Gemcitabine (29,29-difluoro 29-deoxycytidine, dFdC) which developed from cytosine arabinoside (Ara-C) is an nucleoside analog used as chemotherapy. It was intended as an antiviral drug in
OUTLINE: This is a multi-center trial.
INVESTIGATIONAL TREATMENT:
- Palbociclib 125 mg will be administered orally once daily on days 1-21 (D1-D21) of each 28-day cycle. Subjects will not take palbociclib on D22-D28.
- Tamoxifen 20 mg will be administered orally once daily for every day of the
OUTLINE: This is a multi-center trial.
SEQUENCING:
DNA from archived tumor samples collected at the time of surgery (residual disease post neoadjuvant chemotherapy) will be extracted and sequenced. The resulting sequencing data will be interrogated for known genomic drivers of sensitivity or
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are the leading causes of mortality and morbidity in the intensive care unit (ICU). The causes of ALI/ARDS differ from patient to patient, including sepsis, aspiration, systemic inflammation, trauma, blood transfusion, etc. With
OUTLINE: This is a multi-center study.
Safety Run-in will be for the first 12 patients on study only (6 in cohort 1 and 6 in cohort 2). Patients in the safety run will be included in the efficacy analysis on intent to treat basis:
Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles; Rucaparib 16-30 mg
Head and neck squamous cell carcinoma (HNSCC) (excluding nasopharyngeal cancer) accounts for 4% to 5% of the cancer incidence in Taiwan.1 Localized disease is curable by surgery and irradiation. Two-thirds of patients present with advanced stages of the disease (stage III and IV), and are treated
OUTLINE: This is a multi-center study
Patients will be treated with lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
1 Cycle = 21 days of lonafarnib (plus the time required to recover from toxicity if