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
P-660 Finding the optimal starting dose of gonadotropins for an ovarian stimulation treatment through Machine Learning
Sign Up to like & getrecommendations! Published in 2024 at "Human Reproduction"
DOI: 10.1093/humrep/deae108.990
Abstract: Can machine learning algorithms provide an individualized starting dose of gonadotropins to maximize the number of oocytes retrieved in patients undergoing ovarian stimulation ? Methods of Policy Learning based on Causal Inference and Machine Learning… read more here.
Keywords: dose gonadotropins; machine learning; starting dose; regression ... See more keywords
Consecutive real-world treatment experience with a reduced starting dose of lenvatinib (14 mg) plus pembrolizumab for metastatic renal cell carcinoma.
Sign Up to like & getrecommendations! Published in 2025 at "Japanese journal of clinical oncology"
DOI: 10.1093/jjco/hyaf122
Abstract: OBJECTIVE In the CLEAR trials, the starting dose of lenvatinib in lenvatinib+pembrolizumab (L + P) was set at 20 mg for renal cell carcinoma (RCC). The incidence of adverse events is not low with L + P compared with other… read more here.
Keywords: treatment; dose lenvatinib; starting dose; cell carcinoma ... 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
Abstract PO2-18-01: Assessment of Initial Dosing and Dose Management of Sacituzumab Govitecan-hziy (SG) and How Dosing Practices Impact Duration of Therapy (DOT)
Sign Up to like & getrecommendations! Published in 2024 at "Cancer Research"
DOI: 10.1158/1538-7445.sabcs23-po2-18-01
Abstract: Background: As the Phase 3 ASCENT trial’s safety analysis found that a 10m/kg dose of SG resulted in better efficacy than treatment with a lower dose, this examination sought to use real-world data to evaluate… read more here.
Keywords: cancer; starting dose; dot pts; dose reductions ... 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