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Article ; Online: Bilateral transient osteoporosis of the hip in pregnancy.

Thanatsis, Nikolaos / Kollia, Georgia / Gkliatis, John / Decavalas, George / Adonakis, George

Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology

2017 Volume 38, Issue 3, Page(s) 415–416

MeSH term(s)	Absorptiometry, Photon ; Adult ; Cesarean Section ; Female ; Femur/diagnostic imaging ; Gestational Age ; Greece ; Hip Joint ; Humans ; Magnetic Resonance Imaging ; Osteoporosis/complications ; Osteoporosis/diagnosis ; Osteoporosis/therapy ; Pain ; Pregnancy ; Pregnancy Complications/diagnosis ; Range of Motion, Articular
Language	English
Publishing date	2017-10-12
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	604639-3
ISSN	1364-6893 ; 0144-3615
ISSN (online)	1364-6893
ISSN	0144-3615
DOI	10.1080/01443615.2017.1352571
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Article ; Online: Nivolumab dose selection: challenges, opportunities, and lessons learned for cancer immunotherapy.

Agrawal, Shruti / Feng, Yan / Roy, Amit / Kollia, Georgia / Lestini, Brian

Journal for immunotherapy of cancer

2016 Volume 4, Page(s) 72

Abstract: Background: Immuno-oncology (I-O) therapies target the host immune system, providing the potential to choose a uniform dose and schedule across tumor types. However, dose selection for I-O agents usually occurs early in clinical development and is ... ...

Abstract	Background: Immuno-oncology (I-O) therapies target the host immune system, providing the potential to choose a uniform dose and schedule across tumor types. However, dose selection for I-O agents usually occurs early in clinical development and is typically based on tumor response, which may not fully represent the potential for improved overall survival. Here, we describe an integrated approach which incorporates clinical safety and efficacy data with data obtained from analyses of dose-/exposure-response (D-R/E-R) relationships, used to select a monotherapy dose for nivolumab, a programmed death-1 inhibitor, in clinical studies of different tumor types. Methods: Dose was selected based on anti-tumor activity and safety data from a large phase 1b, open-label, dose-escalation study of nivolumab at doses ranging from 0.1 to 10 mg/kg administered every 2 weeks (Q2W) in 306 patients with advanced malignancies, and quantitative analyses were performed to characterize D-R/E-R relationships for pharmacodynamic, safety, and efficacy endpoints. Results: A maximum tolerated dose for nivolumab was not identified, and the safety profile was similar across tumor types and dose levels (0.1-10 mg/kg). Objective response rates (ORRs) were similar across doses in melanoma and renal cell carcinoma (RCC), while higher ORRs were observed in non-small cell lung cancer (NSCLC) at 3 mg/kg and 10 mg/kg versus 1 mg/kg. Peripheral receptor occupancy was saturated at doses ≥ 0.3 mg/kg. In D-R/E-R analyses, a positive dose-dependent objective response trend was observed for each tumor type, but appeared to plateau at nivolumab doses of ≥ 1 mg/kg for melanoma and RCC, and at ≥ 3 mg/kg for NSCLC. Although there was no apparent relationship between tumor shrinkage rate and exposure, tumor progression rate appeared to decrease with increasing exposure up to a dose of 3 mg/kg Q2W for NSCLC. Conclusions: Nivolumab monotherapy at 3 mg/kg Q2W provides unified dosing across tumor types. This dose and schedule has been validated in several phase II/III studies in which overall survival was an endpoint. Integrating D-R/E-R relationships with efficacy data and a safety profile that is unique to I-O therapy is a rational approach for dose selection of these agents.
Language	English
Publishing date	2016
Publishing country	England
Document type	Journal Article
ZDB-ID	2719863-7
ISSN	2051-1426 ; 2051-1426
ISSN (online)	2051-1426
ISSN	2051-1426
DOI	10.1186/s40425-016-0177-2
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Article ; Online: Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2023 Volume 41, Issue 5, Page(s) 943–954

Abstract: Purpose: Programmed cell death 1 (PD-1) is an inhibitory receptor expressed by activated T cells that downmodulates effector functions and limits the generation of immune memory. PD-1 blockade can mediate tumor regression in a substantial proportion of ... ...

Abstract	Purpose: Programmed cell death 1 (PD-1) is an inhibitory receptor expressed by activated T cells that downmodulates effector functions and limits the generation of immune memory. PD-1 blockade can mediate tumor regression in a substantial proportion of patients with melanoma, but it is not known whether this is associated with extended survival or maintenance of response after treatment is discontinued. Patients and methods: Patients with advanced melanoma (N = 107) enrolled between 2008 and 2012 received intravenous nivolumab in an outpatient setting every 2 weeks for up to 96 weeks and were observed for overall survival, long-term safety, and response duration after treatment discontinuation. Results: Median overall survival in nivolumab-treated patients (62% with two to five prior systemic therapies) was 16.8 months, and 1- and 2-year survival rates were 62% and 43%, respectively. Among 33 patients with objective tumor regressions (31%), the Kaplan-Meier estimated median response duration was 2 years. Seventeen patients discontinued therapy for reasons other than disease progression, and 12 (71%) of 17 maintained responses off-therapy for at least 16 weeks (range, 16 to 56+ weeks). Objective response and toxicity rates were similar to those reported previously; in an extended analysis of all 306 patients treated on this trial (including those with other cancer types), exposure-adjusted toxicity rates were not cumulative. Conclusion: Overall survival following nivolumab treatment in patients with advanced treatment-refractory melanoma compares favorably with that in literature studies of similar patient populations. Responses were durable and persisted after drug discontinuation. Long-term safety was acceptable. Ongoing randomized clinical trials will further assess the impact of nivolumab therapy on overall survival in patients with metastatic melanoma.
Language	English
Publishing date	2023-02-07
Publishing country	United States
Document type	Journal Article ; Corrected and Republished Article
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.22.02272
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Article ; Online: BMS-986012, an Anti-Fucosyl-GM1 Monoclonal Antibody as Monotherapy or in Combination With Nivolumab in Relapsed/Refractory SCLC: Results From a First-in-Human Phase 1/2 Study.

Chu, Quincy / Leighl, Natasha B / Surmont, Veerle / van Herpen, Carla / Sibille, Anne / Markman, Ben / Clarke, Stephen / Juergens, Rosalyn A / Rivera, Mirelis Acosta / Andelkovic, Vladimir / Rudin, Charles M / Snow, Stephanie / Kim, Dong-Wan / Sanatani, Michael / Lin, Hongxia / Sanghavi, Kinjal / Tannenbaum-Dvir, Sarah / Basciano, Paul / Lathers, Deanne /

Urbanska, Katarzyna / Kollia, Georgia / He, Chunsheng / DiPiero, Andrew / Liu, Yu / Ready, Neal

JTO clinical and research reports

2022 Volume 3, Issue 11, Page(s) 100400

Abstract: Introduction: Fucosyl-GM1 is a monosialoganglioside with limited expression in healthy tissues and high expression on SCLC cells. BMS-986012 is a nonfucosylated, first-in-class, fully human immunoglobulin G1 monoclonal antibody that binds to fucosyl-GM1. ...

Abstract	Introduction: Fucosyl-GM1 is a monosialoganglioside with limited expression in healthy tissues and high expression on SCLC cells. BMS-986012 is a nonfucosylated, first-in-class, fully human immunoglobulin G1 monoclonal antibody that binds to fucosyl-GM1. Methods: CA001-030 is a phase 1/2, first-in-human study of BMS-986012 as monotherapy or in combination with nivolumab for adults with relapsed or refractory SCLC. Safety is the primary end point. Additional end points include objective response rate, duration of response, progression-free survival, pharmacokinetics, and overall survival. Results: Patients (BMS-986012 monotherapy, n = 77; BMS-986012 + nivolumab, n = 29) were predominantly of male sex (58%), 63 years old (mean), current or past tobacco users (97%), and treated previously with first-line systemic therapy (99%). The most common treatment-related adverse event was pruritus (n = 95 [90%]). Grade 4 treatment-related adverse events were reported in 2% (n = 2) of patients. The objective response rate (95% confidence interval [CI]) was higher with BMS-986012 plus nivolumab (38% [20.7%-57.7%]) than with monotherapy (4% [0.8%-11.0%]). Median (95% CI) duration of response with BMS-986012 plus nivolumab was 26.4 (4.4-not reached) months. Progression-free survival (95% CI) at 24 weeks with monotherapy and BMS-986012 plus nivolumab was 12.2% (6.0%-20.7%) and 39.3% (21.7%-56.5%), respectively. The pharmacokinetics profile of monotherapy and BMS-986012 plus nivolumab suggested dose proportionality across the tested dose range. Median overall survival (95% CI) with monotherapy and BMS-986012 plus nivolumab was 5.4 (4.0-7.3) and 18.7 (8.2-37.3) months, respectively. Conclusions: BMS-986012 in combination with nivolumab represents a well-tolerated, potential new therapy for relapsed or refractory SCLC. BMS-986012 is currently being explored in combination with carboplatin, etoposide, and nivolumab as a first-line therapy in extensive-stage SCLC (NCT04702880).
Language	English
Publishing date	2022-08-27
Publishing country	United States
Document type	Journal Article
ISSN	2666-3643
ISSN (online)	2666-3643
DOI	10.1016/j.jtocrr.2022.100400
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Article: BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extraterminal Domain Proteins, in Patients with Selected Advanced Solid Tumors: Results from a Phase 1/2a Trial.

Cancers

2022 Volume 14, Issue 17

Abstract: This phase 1/2a, open-label study (NCT02419417) evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of BMS-986158, a selective bromodomain and extraterminal domain (BET) inhibitor. Dose escalation was performed with 3 BMS- ... ...

Abstract	This phase 1/2a, open-label study (NCT02419417) evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of BMS-986158, a selective bromodomain and extraterminal domain (BET) inhibitor. Dose escalation was performed with 3 BMS-986158 dosing schedules: A (5 days on, 2 days off; range, 0.75-4.5 mg), B (14 days on, 7 days off; 2.0-3.0 mg), and C (7 days on, 14 days off; 2.0-4.5 mg). Eighty-three patients were enrolled and received ≥1 BMS-986158 dose. Diarrhea (43%) and thrombocytopenia (39%) were the most common treatment-related adverse events (TRAEs). A lower incidence of TRAEs was found with schedules A (72%) and C (72%) vs. B (100%). Stable disease was achieved in 12 (26.1%), 3 (37.5%), and 9 (31.0%) patients on schedules A, B, and C, respectively. Two patients on schedule A with a 4.5-mg starting dose (ovarian cancer, n = 1; nuclear protein in testis [NUT] carcinoma, n = 1) experienced a partial response. BMS-986158 demonstrated rapid-to-moderate absorption (median time to maximum observed plasma concentration, 1-4 h). As expected with an epigenetic modifier, expression changes in select BET-regulated genes occurred with BMS-986158 treatment. Schedule A dosing (5 days on, 2 days off) yielded tolerable safety, preliminary antitumor activity, and a dose-proportional PK profile.
Language	English
Publishing date	2022-08-23
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers14174079
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Article ; Online: Lack of effect of brivanib on the pharmacokinetics of midazolam, a CYP3A4 substrate, administered intravenously and orally in healthy participants.

Syed, Shariq / Clemens, Pamela L / Lathers, Deanne / Kollia, Georgia / Dhar, Arindam / Walters, Ian / Masson, Eric

Journal of clinical pharmacology

2011 Volume 52, Issue 6, Page(s) 914–921

Abstract: Brivanib alaninate is the orally available prodrug of brivanib, a dual inhibitor of fibroblast growth factor and vascular endothelial growth factor signaling pathways that is under therapeutic investigation for various malignancies. Brivanib alaninate ... ...

Abstract	Brivanib alaninate is the orally available prodrug of brivanib, a dual inhibitor of fibroblast growth factor and vascular endothelial growth factor signaling pathways that is under therapeutic investigation for various malignancies. Brivanib alaninate inhibits CYP3A4 in vitro, and thus there is potential for drug-drug interaction with CYP3A4 substrates, such as midazolam. The present study evaluated pharmacokinetic parameters and safety/tolerability upon coadministration of brivanib alaninate and midazolam. Healthy participants received intravenous (IV) or oral midazolam with and without oral brivanib alaninate. Blood samples for pharmacokinetic analysis were collected up to 12 hours after midazolam and up to 48 hours after brivanib alaninate. Twenty-four participants were administered study drugs; 21 completed the trial. No clinically relevant effect of brivanib alaninate on the overall exposure to midazolam following IV or oral administration was observed. Orally administered brivanib alaninate was generally well tolerated in the presence of IV or oral midazolam. The lack of a pharmacokinetic interaction between brivanib and midazolam indicates that brivanib alaninate does not influence either intestinal or hepatic CYP3A4 and confirms that brivanib alaninate may be safely coadministered with midazolam and other CYP3A4 substrates.
MeSH term(s)	Administration, Oral ; Adult ; Alanine/adverse effects ; Alanine/analogs & derivatives ; Alanine/blood ; Alanine/pharmacokinetics ; Alanine/pharmacology ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/blood ; Antineoplastic Agents/pharmacokinetics ; Antineoplastic Agents/pharmacology ; Cross-Over Studies ; Cytochrome P-450 CYP3A/metabolism ; Cytochrome P-450 CYP3A Inhibitors ; Dose-Response Relationship, Drug ; Drug Interactions ; Female ; Fibroblast Growth Factors/antagonists & inhibitors ; Half-Life ; Humans ; Injections, Intravenous ; Intestines/drug effects ; Intestines/enzymology ; Liver/drug effects ; Liver/enzymology ; Male ; Metabolic Detoxication, Phase I ; Midazolam/administration & dosage ; Midazolam/adverse effects ; Midazolam/blood ; Midazolam/pharmacokinetics ; Middle Aged ; Patient Dropouts ; Prodrugs/adverse effects ; Prodrugs/pharmacokinetics ; Prodrugs/pharmacology ; Receptors, Vascular Endothelial Growth Factor/antagonists & inhibitors ; Triazines/adverse effects ; Triazines/blood ; Triazines/pharmacokinetics ; Triazines/pharmacology
Chemical Substances	Antineoplastic Agents ; Cytochrome P-450 CYP3A Inhibitors ; Prodrugs ; Triazines ; Fibroblast Growth Factors (62031-54-3) ; brivanib (DDU33B674I) ; Cytochrome P-450 CYP3A (EC 1.14.14.1) ; CYP3A4 protein, human (EC 1.14.14.55) ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1) ; Alanine (OF5P57N2ZX) ; Midazolam (R60L0SM5BC)
Language	English
Publishing date	2011-06-09
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1177/0091270011407495
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Article ; Online: Lack of food effect on single-dose pharmacokinetics of brivanib, and safety and efficacy following multiple doses in subjects with advanced or metastatic solid tumors.

LoRusso, Patricia / Shapiro, Geoffrey I / Hurwitz, Herbert / Pilat, Mary Jo / Chemidlin, Janice / Kollia, Georgia / Syed, Shariq / Fischer, Bruce / Masson, Eric

Cancer chemotherapy and pharmacology

2011 Volume 68, Issue 6, Page(s) 1377–1385

Abstract: Purpose: Brivanib alaninate, an orally available prodrug of brivanib, is currently under evaluation for the treatment of several malignancies. This study aimed to (1) investigate effects of a high-fat meal on single-dose pharmacokinetics of brivanib in ... ...

Abstract	Purpose: Brivanib alaninate, an orally available prodrug of brivanib, is currently under evaluation for the treatment of several malignancies. This study aimed to (1) investigate effects of a high-fat meal on single-dose pharmacokinetics of brivanib in subjects with advanced/metastatic solid tumors and (2) assess the safety and preliminary efficacy of single and multiple doses of brivanib alaninate in this population. Methods: A two-part study was conducted consisting of a single-dose phase (Part A) and a multiple-dose phase (Part B). In Part A, subjects received a single dose of brivanib alaninate (800 mg) either in a fasting state or following ingestion of a high-fat meal (approximately 951 kcal [15% protein, 33% carbohydrate, 52% fat]); serial blood samples were collected for pharmacokinetic analysis up to 48 h post-dosing. In Part B, subjects received brivanib alaninate (800 mg) once daily until discontinuation. Throughout both phases, subjects were evaluated for adverse events (AEs) and best clinical response. Results: No clinically significant differences in brivanib exposure were observed between fed and fasting subjects in Part A; C (max) was unchanged and AUC(INF) decreased marginally when administered in a fed versus fasted state. In Part A, the incidence of treatment-emergent AEs was broadly similar in a fed or fasted state. Brivanib alaninate was generally well tolerated throughout the study and showed preliminary evidence of antitumor activity. Conclusions: Consumption of a high-fat meal had no significant effect on brivanib pharmacokinetics. The study further demonstrates the acceptable safety/tolerability profile and antitumor potential of brivanib in patients with advanced malignancies.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Alanine/administration & dosage ; Alanine/adverse effects ; Alanine/analogs & derivatives ; Alanine/pharmacokinetics ; Antineoplastic Agents/pharmacokinetics ; Cross-Over Studies ; Female ; Food ; Humans ; Male ; Middle Aged ; Neoplasm Metastasis ; Neoplasms/drug therapy ; Triazines/administration & dosage ; Triazines/adverse effects ; Triazines/pharmacokinetics
Chemical Substances	Antineoplastic Agents ; Triazines ; brivanib (DDU33B674I) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2011-12
Publishing country	Germany
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	6820-2
ISSN	1432-0843 ; 0344-5704 ; 0943-9404
ISSN (online)	1432-0843
ISSN	0344-5704 ; 0943-9404
DOI	10.1007/s00280-011-1603-2
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Article ; Online: Repeatability of 18F-FDG PET in a multicenter phase I study of patients with advanced gastrointestinal malignancies.

Velasquez, Linda M / Boellaard, Ronald / Kollia, Georgia / Hayes, Wendy / Hoekstra, Otto S / Lammertsma, Adriaan A / Galbraith, Susan M

Journal of nuclear medicine : official publication, Society of Nuclear Medicine

2009 Volume 50, Issue 10, Page(s) 1646–1654

Abstract: Unlabelled: (18)F-FDG PET is often used to monitor tumor response in multicenter oncology clinical trials. This study assessed the repeatability of several semiquantitative standardized uptake values (mean SUV [SUV(mean)], maximum SUV [SUV(max)], peak ... ...

Abstract	Unlabelled: (18)F-FDG PET is often used to monitor tumor response in multicenter oncology clinical trials. This study assessed the repeatability of several semiquantitative standardized uptake values (mean SUV [SUV(mean)], maximum SUV [SUV(max)], peak SUV [SUV(peak)], and the 3-dimensional isocontour at 70% of the maximum pixel value [SUV(70%)]) as measured by repeated baseline (18)F-FDG PET studies in a multicenter phase I oncology trial. Methods: Double-baseline (18)F-FDG PET studies were acquired for 62 sequentially enrolled patients. Tumor metabolic activity was assessed by SUV(mean), SUV(max), SUV(peak), and SUV(70%). The effect on SUV repeatability of compliance with recommended image-acquisition guidelines and quality assurance (QA) standards was assessed. Summary statistics for absolute differences relative to the average of baseline values and repeatability analysis were performed for all patients and for a subgroup that passed QA, in both a multi- and a single-observer setting. Intrasubject precision of baseline measurements was assessed by repeatability coefficients, intrasubject coefficients of variation (CV), and confidence intervals on mean baseline differences for all SUV parameters. Results: The mean differences between the 2 SUV baseline measurements were small, varying from -2.1% to 1.9%, and the 95% confidence intervals for these mean differences had a maximum half-width of about 5.6% across the SUV parameters assessed. For SUV(max), the intrasubject CV varied from 10.7% to 12.8% for the QA multi- and single-observer datasets and was 16% for the full dataset. The 95% repeatability coefficients ranged from -28.4% to 39.6% for the QA datasets and up to -34.3% to 52.3% for the full dataset. Conclusion: Repeatability results of double-baseline (18)F-FDG PET scans were similar for all SUV parameters assessed, for both the full and the QA datasets, in both the multi- and the single-observer settings. Centralized quality assurance and analysis of data improved intrasubject CV from 15.9% to 10.7% for averaged SUV(max). Thresholds for metabolic response in the multicenter multiobserver non-QA settings were -34% and 52% and in the range of -26% to 39% with centralized QA. These results support the use of (18)F-FDG PET for tumor assessment in multicenter oncology clinical trials.
MeSH term(s)	Adult ; Aged ; Female ; Fluorodeoxyglucose F18/metabolism ; Gastrointestinal Neoplasms/diagnostic imaging ; Gastrointestinal Neoplasms/metabolism ; Gastrointestinal Neoplasms/pathology ; Humans ; Male ; Middle Aged ; Positron-Emission Tomography ; Quality Control ; Reproducibility of Results ; Research Design
Chemical Substances	Fluorodeoxyglucose F18 (0Z5B2CJX4D)
Language	English
Publishing date	2009-10
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	80272-4
ISSN	1535-5667 ; 0097-9058 ; 0161-5505 ; 0022-3123
ISSN (online)	1535-5667
ISSN	0097-9058 ; 0161-5505 ; 0022-3123
DOI	10.2967/jnumed.109.063347
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Article ; Online: The effects of liver impairment on the pharmacokinetics of brivanib, a dual inhibitor of fibroblast growth factor receptor and vascular endothelial growth factor receptor tyrosine kinases.

El-Khoueiry, Anthony / Posey, James A / Castillo Ferrando, Juan Ramón / Krishnamurthi, Smitha S / Syed, Shariq / Kollia, Georgia / Walters, Ian / Fischer, Bruce S / Masson, Eric

Cancer chemotherapy and pharmacology

2013 Volume 72, Issue 1, Page(s) 53–64

Abstract: Purpose: Hepatic impairment may impede tyrosine kinase inhibitor metabolism. This phase I study compared the pharmacokinetics of brivanib in patients with hepatocellular carcinoma (HCC) and varying levels of hepatic impairment with those with non-HCC ... ...

Abstract	Purpose: Hepatic impairment may impede tyrosine kinase inhibitor metabolism. This phase I study compared the pharmacokinetics of brivanib in patients with hepatocellular carcinoma (HCC) and varying levels of hepatic impairment with those with non-HCC malignancies and normal liver function. Methods: Patients were assigned to the following groups: Groups A, B, and C (HCC plus mild, moderate, or severe hepatic impairment, respectively) and Group D (non-HCC malignancy and normal hepatic function). Brivanib alaninate (brivanib prodrug) doses were 400 mg in Groups A, B, and D and 200 mg in Group C. Brivanib exposure was determined on day 1 (single dose) and day 28 (multiple doses). Results: Twenty-four patients participated in the study. After a single brivanib alaninate dose, brivanib exposure was comparable between Groups A, B, and D. Area under the concentration-time curve was 50 % higher in Group C versus Group D. There were not enough data to draw conclusions on multiple doses. Safety profile in Groups A, B, and D was consistent with previous brivanib monotherapy experience. Tolerability could not be assessed in Group C because of dose interruptions and discontinuations, generally due to the disease natural history. Conclusions: Brivanib exposure was similar in patients with HCC and mild or moderate hepatic impairment (Child-Pugh [CP] A or B status) and those with non-HCC malignancies and normal hepatic function, suggesting dose adjustment is unnecessary with CP A or B status. Experience with HCC and severe hepatic impairment (CP C status) is insufficient to recommend brivanib use in this population.
MeSH term(s)	Aged ; Aged, 80 and over ; Alanine/administration & dosage ; Alanine/adverse effects ; Alanine/analogs & derivatives ; Alanine/pharmacokinetics ; Alanine/therapeutic use ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/pharmacokinetics ; Antineoplastic Agents/therapeutic use ; Carcinoma, Hepatocellular/blood ; Carcinoma, Hepatocellular/complications ; Carcinoma, Hepatocellular/metabolism ; Carcinoma, Hepatocellular/physiopathology ; Cohort Studies ; Dose-Response Relationship, Drug ; Female ; Half-Life ; Hepatic Insufficiency/blood ; Hepatic Insufficiency/complications ; Hepatic Insufficiency/etiology ; Hepatic Insufficiency/physiopathology ; Humans ; Liver/drug effects ; Liver/metabolism ; Liver/physiopathology ; Liver Neoplasms/blood ; Liver Neoplasms/complications ; Liver Neoplasms/metabolism ; Liver Neoplasms/physiopathology ; Male ; Metabolic Clearance Rate ; Middle Aged ; Patient Dropouts ; Prodrugs/administration & dosage ; Prodrugs/adverse effects ; Prodrugs/pharmacokinetics ; Prodrugs/therapeutic use ; Protein Kinase Inhibitors/administration & dosage ; Protein Kinase Inhibitors/adverse effects ; Protein Kinase Inhibitors/pharmacokinetics ; Protein Kinase Inhibitors/therapeutic use ; Receptors, Fibroblast Growth Factor/antagonists & inhibitors ; Receptors, Vascular Endothelial Growth Factor/antagonists & inhibitors ; Severity of Illness Index ; Triazines/administration & dosage ; Triazines/adverse effects ; Triazines/pharmacokinetics ; Triazines/therapeutic use
Chemical Substances	Antineoplastic Agents ; Prodrugs ; Protein Kinase Inhibitors ; Receptors, Fibroblast Growth Factor ; Triazines ; brivanib (DDU33B674I) ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2013-07
Publishing country	Germany
Document type	Clinical Trial, Phase I ; Controlled Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	6820-2
ISSN	1432-0843 ; 0344-5704 ; 0943-9404
ISSN (online)	1432-0843
ISSN	0344-5704 ; 0943-9404
DOI	10.1007/s00280-013-2168-z
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Article: Pharmacokinetics and tolerability of intramuscular, oral and intravenous aripiprazole in healthy subjects and in patients with schizophrenia.

Boulton, David W / Kollia, Georgia / Mallikaarjun, Suresh / Komoroski, Bernard / Sharma, Anjali / Kovalick, Lawrence J / Reeves, Richard A

Clinical pharmacokinetics

2008 Volume 47, Issue 7, Page(s) 475–485

Abstract: Background and objective: Patients with schizophrenia or bipolar disorder who are experiencing acute behavioural emergencies often require intramuscular injection of antipsychotics for rapid symptom resolution. The efficacy and tolerability of ... ...

Abstract	Background and objective: Patients with schizophrenia or bipolar disorder who are experiencing acute behavioural emergencies often require intramuscular injection of antipsychotics for rapid symptom resolution. The efficacy and tolerability of intramuscular aripiprazole injection has been established in agitated inpatients with schizophrenia or bipolar I disorder. The main objective of the two clinical pharmacology studies reported here was to evaluate the pharmacokinetics of aripiprazole after intramuscular dosing in healthy subjects and in patients with schizophrenia, and after intravenous and oral dosing in healthy subjects. Subjects and methods: Study 1 was an open-label, randomized, three-treatment crossover study in healthy subjects (n = 18) to assess the bioavailability and pharmacokinetics of intramuscular aripiprazole 5 mg and oral aripiprazole 5 mg relative to intravenous aripiprazole 2 mg. Study 2 was an open-label, nonrandomized, escalating-dose study in patients with schizophrenia (n = 32) to evaluate the pharmacokinetics of intramuscular aripiprazole across a range of doses (from 1 mg to 45 mg). Main outcome measures: The noncompartmental pharmacokinetic parameters for plasma concentrations of aripiprazole and its active metabolite dehydro-aripiprazole were determined. Safety and tolerability data are also summarized. Results: In study 1, the geometric mean values for the absolute bioavailability of aripiprazole following oral and intramuscular administration were 0.85 and 0.98, respectively. Intramuscular aripiprazole demonstrated more rapid attainment of plasma aripiprazole concentrations than oral aripiprazole (78% and 5% of peak plasma concentration [C(max)] values at 0.5 hours postdose, respectively). The area under the plasma concentration-time curve (AUC) in the first 2 hours was 90% higher after intramuscular administration than after oral administration. For dehydro-aripiprazole, the AUC over the collection interval values were higher, the times to reach the C(max) values were later and the C(max) values were similar for the intramuscular and oral formulations. In study 2, the proportionality of the C(max) and AUC to doses ranging from 1 mg to 45 mg suggests a linear pharmacokinetic profile for intramuscular aripiprazole. Conclusion: More rapid absorption was observed following intramuscular aripiprazole injection than following oral dosing. These results support the recently reported efficacy of intramuscular aripiprazole for managing agitation in patients with schizophrenia or bipolar I disorder.
MeSH term(s)	Administration, Oral ; Adolescent ; Adult ; Antipsychotic Agents/administration & dosage ; Antipsychotic Agents/adverse effects ; Antipsychotic Agents/pharmacokinetics ; Area Under Curve ; Aripiprazole ; Biological Availability ; Biotransformation ; Cross-Over Studies ; Dose-Response Relationship, Drug ; Female ; Humans ; Injections, Intramuscular ; Injections, Intravenous ; Male ; Middle Aged ; Piperazines/administration & dosage ; Piperazines/adverse effects ; Piperazines/pharmacokinetics ; Quinolones/administration & dosage ; Quinolones/adverse effects ; Quinolones/pharmacokinetics ; Schizophrenia/drug therapy ; Schizophrenia/metabolism ; Young Adult
Chemical Substances	Antipsychotic Agents ; Piperazines ; Quinolones ; Aripiprazole (82VFR53I78)
Language	English
Publishing date	2008-06-19
Publishing country	Switzerland
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	197627-8
ISSN	1179-1926 ; 0312-5963
ISSN (online)	1179-1926
ISSN	0312-5963
DOI	10.2165/00003088-200847070-00004
Database	MEDical Literature Analysis and Retrieval System OnLINE

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