Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs
Sign Up to like & getrecommendations! Published in 2020 at "Cancer Chemotherapy and Pharmacology"
DOI: 10.1007/s00280-020-04202-0
Abstract: The ideal starting dose for an oncology first-in-patient (FIP) trial should be low enough to be safe but not too far removed from therapeutically relevant doses. A low starting dose combined with small dose increments… read more here.
Keywords: first patient; dose escalation; starting dose; small molecule ... See more keywords
Getting a molecule into the clinic: Nonclinical testing and starting dose considerations
Sign Up to like & getrecommendations! Published in 2017 at "Regulatory Toxicology and Pharmacology"
DOI: 10.1016/j.yrtph.2017.07.027
Abstract: &NA; Examination of content of 35 Investigator Brochures (IBs) for small molecules (including some for oncology) used to support First‐In‐Human studies over a 2 year period (2014–2016) showed that a mean of 37 nonclinical studies… read more here.
Keywords: molecule; starting dose; pharmacology; toxicology testing ... See more keywords
Starting dose and dose adjustment of non-vitamin K antagonist oral anticoagulation agents in a nationwide cohort of patients with atrial fibrillation
Sign Up to like & getrecommendations! Published in 2021 at "Scientific Reports"
DOI: 10.1038/s41598-021-99818-4
Abstract: This study aims to provide real-world data about starting-dose of NOACs and dose-adjustment in patients with atrial fibrillation (AF). In fact, even if new oral anticoagulation agents (NOACs) have a predictable effect without need for… read more here.
Keywords: atrial fibrillation; starting dose; anticoagulation agents; dose adjustment ... See more keywords
The interchangeability of two assays for the measurement of anti-Müllerian hormone when personalizing the dose of FSH in in-vitro fertilization cycles
Sign Up to like & getrecommendations! Published in 2020 at "Gynecological Endocrinology"
DOI: 10.1080/09513590.2020.1810659
Abstract: Abstract Objective Study the interchangeability of Roche Elecsys and Beckman Coulter Access anti-Müllerian Hormone (AMH) assays to select the gonadotropin starting dose in IVF cycles. Methods Patients’ AMH was measured using both Elecsys and Access… read more here.
Keywords: anti llerian; starting dose; interchangeability; llerian hormone ... See more keywords
1601: IMPACT OF THE STARTING DOSE OF NOREPINEPHRINE ON RENAL OUTCOMES IN SEPTIC SHOCK PATIENTS
Sign Up to like & getrecommendations! Published in 2020 at "Critical Care Medicine"
DOI: 10.1097/01.ccm.0000648312.80651.70
Abstract: Introduction/Hypothesis: Septic shock results in high rates of morbidity and mortality. There are no consensus guideline recommendations with regards to the starting dose. It is recommended to titrate vasopressors to a mean arterial pressure (MAP)… read more here.
Keywords: starting dose; dose norepinephrine; need rrt; septic shock ... See more keywords
Overweight Kidney Transplant Recipients Are at Risk of Being Overdosed Following Standard Bodyweight-Based Tacrolimus Starting Dose
Sign Up to like & getrecommendations! Published in 2017 at "Transplantation Direct"
DOI: 10.1097/txd.0000000000000644
Abstract: Background Bodyweight-based dosing of tacrolimus (Tac) is considered standard care, even though the available evidence is thin. An increasing proportion of transplant recipients is overweight, prompting the question if the starting dose should always be… read more here.
Keywords: starting dose; following standard; standard bodyweight; bodyweight based ... See more keywords
First in human dose calculation of a single-chain bispecific antibody targeting glioma using the MABEL approach
Sign Up to like & getrecommendations! Published in 2020 at "Journal for Immunotherapy of Cancer"
DOI: 10.1136/jitc-2019-000213
Abstract: Background First-in-human (FIH) clinical trials require careful selection of a safe yet biologically relevant starting dose. Typically, such starting doses are selected based on toxicity studies in a pharmacologically relevant animal model. However, with the… read more here.
Keywords: hegfrviii cd3; mabel; starting dose; cd3 scfv ... See more keywords
One Size Does Not Fit to All: Intolerant or Resistant CML Patients Could Benefit from Different Ponatinib Starting Dose Strategies. Multicenter Italian Experience
Sign Up to like & getrecommendations! Published in 2018 at "Blood"
DOI: 10.1182/blood-2018-99-116825
Abstract: Background: Ponatinib is effective as salvage treatment for chronic phase (CP) Ph+ chronic myeloid leukemia (CML) patients resistant or intolerant to prior TKIs. Based on the concern for an unfavourable cardiovascular toxicity profile, a dose… read more here.
Keywords: cml patients; starting dose; treatment; honoraria ... See more keywords
The effect of sorafenib (S) starting dose and dose intensity on survival in patients with advanced hepatocellular carcinoma (HCC).
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2017.35.4_suppl.400
Abstract: 400Background: The SHARP trial showed that S improves survival in advanced HCC. In clinical practice full dose (FD) of S at 400mg bid can be difficult to tolerate and so a reduced dose (RD) is… read more here.
Keywords: starting dose; intensity; survival patients; dose intensity ... See more keywords
CaboRISE: A phase II study evaluating reduced starting dose and dose escalation of cabozantinib as second-line therapy for advanced HCC in patients with compensated liver cirrhosis.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2021.39.15_suppl.tps4163
Abstract: TPS4163 Background: The multi-targeted tyrosine kinase inhibitor cabozantinib is approved for the treatment of advanced hepatocellular carcinoma (HCC) in adults, who have previously been treated with sorafenib. In the pivotal phase 3 CELESTIAL trial a… read more here.
Keywords: starting dose; reduced starting; treatment; line ... See more keywords
Comparison of two different starting dose of rhFSH in GnRH antagonist protocol for patients with normal ovarian reserve
Sign Up to like & getrecommendations! Published in 2023 at "Frontiers in Endocrinology"
DOI: 10.3389/fendo.2023.1068141
Abstract: Objective To evaluate different starting doses of recombinant human follicle-stimulating hormone (rhFSH) on pregnancy outcomes for patients with normal ovarian reserve during gonadotropin- releasing hormone antagonist (GnRH-ant) protocol-controlled ovarian stimulation of in vitro fertilization (IVF)… read more here.
Keywords: ovarian reserve; dose rhfsh; patients normal; normal ovarian ... See more keywords