scholarly journals Correction to: Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study

BMC Urology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Hiroji Uemura ◽  
Yosuke Koroki ◽  
Yuki Iwaki ◽  
Keiichiro Imanaka ◽  
Takeshi Kambara ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Skin Rash ◽  
Advanced Prostate Cancer ◽  
Phase 1 ◽  
Japanese Patients ◽  
Integrated Analysis ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Study ◽  
Label Study

An amendment to this paper has been published and can be accessed via the original article.

scholarly journals Skin Rash Following Administration of Apalutamide in Japanese Patients with Advanced Prostate Cancer: An Integrated Analysis of the Phase 3 SPARTAN and TITAN Studies and a Phase 1 Open-Label Study

2020 ◽  
Author(s):  
Hiroji Uemura ◽  
Yosuke Koroki ◽  
Yuki Iwaki ◽  
Keiichiro Imanaka ◽  
Takeshi Kambara ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Skin Rash ◽  
Phase 1 ◽  
Japanese Patients ◽  
Clinical Risk Factors ◽  
Integrated Analysis ◽  
Plasma Exposure ◽  
Phase 3 ◽  
Clinical Risk

Abstract Background: A higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC). Methods: This integrated analysis of data of Japanese patients from 2 global Phase 3 studies, SPARTAN (NCT01946204; patients with non‑metastatic castration-resistant PC [nmCRPC]) and TITAN (NCT02489318; patients with metastatic castration-sensitive PC [mCSPC]), and the Phase 1 study 56021927PCR1008 (NCT02162836; patients with metastatic CRPC [mCRPC]), assessed clinical risk factors of apalutamide-related skin rash as well as the potential correlation with plasma exposure to apalutamide. Kaplan-Meier method was used for time-to-event analyses. Clinical risk factors for skin rash were assessed using odds ratio. Results: Data from 68 patients ( SPARTAN: n=34, TITAN: n=28, 56021927PCR1008: n=6) receiving apalutamide 240 mg orally once-daily were analyzed. Rash (13 [19.1%]) and maculo-papular rash (11 [16.2%]) were the most frequently reported skin rash. All Grade and Grade 3 skin rash occurred in 35 (51.5%) and 10 (14.7%) patients, respectively. Most (85.7%) skin rash occurred within 4 months of apalutamide initiation and resolved in a median time of 1 month following the use of antihistamines, topical or systemic corticosteroids, with/without apalutamide dose interruptions/reductions. Median time-to-remission of first incidence of rash and maximum grade incidence of rash were 1.0 month (IQR: 0.36-1.81) and 1.0 month (IQR: 0.30-2.43), respectively. No significant clinical risk factors for the incidence of skin rash were observed. Areas under the curve (0-24 hours) (AUC 0-24, ss ) at steady‑state of plasma apalutamide concentration were numerically slightly higher in patients with skin rash than those without. Conclusions: No clinical risk factors for rash could be detected. There is a potential correlation between incidence of skin rash and plasma exposure to apalutamide. In general, apalutamide‑related skin rash is easily managed, with appropriate treatment with or without dose adjustment.

scholarly journals Skin Rash Following Administration of Apalutamide in Japanese Patients with Advanced Prostate Cancer: An Integrated Analysis of the Phase 3 SPARTAN and TITAN Studies and a Phase 1 Open-Label Study

2020 ◽  
Author(s):  
Hiroji Uemura ◽  
Yosuke Koroki ◽  
Yuki Iwaki ◽  
Keiichiro Imanaka ◽  
Takeshi Kambara ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Skin Rash ◽  
Phase 1 ◽  
Japanese Patients ◽  
Clinical Risk Factors ◽  
Integrated Analysis ◽  
Plasma Exposure ◽  
Phase 3 ◽  
Clinical Risk

Abstract Background A higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC).Methods This integrated analysis of data of Japanese patients from 2 global Phase 3 studies, SPARTAN (NCT01946204; patients with nonmetastatic castration-resistant PC [nmCRPC]) and TITAN (NCT02489318; patients with metastatic castration-sensitive PC [mCSPC]), and the Phase 1 study 56021927PCR1008 (NCT02162836; patients with metastatic CRPC [mCRPC]), assessed clinical risk factors of apalutamide-related skin rash as well as the potential correlation with plasma exposure to apalutamide. Kaplan-Meier method was used for time-to-event analyses. Clinical risk factors for skin rash were assessed using odds ratio.Results Data from 68 patients (SPARTAN: n = 34, TITAN: n = 28, 56021927PCR1008: n = 6) receiving apalutamide 240 mg orally once-daily were analysed. Rash (13 [19.1%]) and maculo-papular rash (11 [16.2%]) were the most frequently reported skin rash. All Grade and Grade 3 skin rash occurred in 35 (51.5%) and 10 (14.7%) patients, respectively. Most (85.7%) skin rash occurred within 4 months of apalutamide initiation and resolved in a median time of 1 month following the use of antihistamines, topical or systemic corticosteroids, with/without apalutamide dose interruptions/reductions. No significant clinical risk factors for the incidence of skin rash were observed. Areas under the curve (0–24 hours) (AUC0 − 24ss) at steadystate of plasma apalutamide concentration were numerically slightly higher in patients with skin rash than those without.Conclusions No clinical risk factors for rash could be detected. There is a potential correlation between incidence of skin rash and plasma exposure to apalutamide. In general, apalutamiderelated skin rash is easily managed, with appropriate treatment with or without dose adjustment.

scholarly journals Skin Rash Following Administration of Apalutamide in Japanese Patients with Advanced Prostate Cancer: An Integrated Analysis of the Phase 3 SPARTAN and TITAN Studies and a Phase 1 Open-Label Study

2020 ◽  
Author(s):  
Hiroji Uemura ◽  
Yosuke Koroki ◽  
Yuki Iwaki ◽  
Keiichiro Imanaka ◽  
Takeshi Kambara ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Skin Rash ◽  
Phase 1 ◽  
Japanese Patients ◽  
Clinical Risk Factors ◽  
Integrated Analysis ◽  
Plasma Exposure ◽  
Phase 3 ◽  
Clinical Risk

Abstract Background: A higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC). Methods: This integrated analysis of data of Japanese patients from 2 global Phase 3 studies, SPARTAN (NCT01946204; patients with non‑metastatic castration-resistant PC [nmCRPC]) and TITAN (NCT02489318; patients with metastatic castration-sensitive PC [mCSPC]), and the Phase 1 study 56021927PCR1008 (NCT02162836; patients with metastatic CRPC [mCRPC]), assessed clinical risk factors of apalutamide-related skin rash as well as the potential correlation with plasma exposure to apalutamide. Kaplan-Meier method was used for time-to-event analyses. Clinical risk factors for skin rash were assessed using odds ratio.Results: Data from 68 patients (SPARTAN: n=34, TITAN: n=28, 56021927PCR1008: n=6) receiving apalutamide 240 mg orally once-daily were analyzed. Rash (13 [19.1%]) and maculo-papular rash (11 [16.2%]) were the most frequently reported skin rash. All Grade and Grade 3 skin rash occurred in 35 (51.5%) and 10 (14.7%) patients, respectively. Most (85.7%) skin rash occurred within 4 months of apalutamide initiation and resolved in a median time of 1 month following the use of antihistamines, topical or systemic corticosteroids, with/without apalutamide dose interruptions/reductions. Median time-to-remission of first incidence of rash and maximum grade incidence of rash were 1.0 month (IQR: 0.36-1.81) and 1.0 month (IQR: 0.30-2.43), respectively. No significant clinical risk factors for the incidence of skin rash were observed. Areas under the curve (0-24 hours) (AUC0-24, ss) at steady‑state of plasma apalutamide concentration were numerically slightly higher in patients with skin rash than those without.Conclusions: No clinical risk factors for rash could be detected. There is a potential correlation between incidence of skin rash and plasma exposure to apalutamide. In general, apalutamide‑related skin rash is easily managed, with appropriate treatment with or without dose adjustment. Trial Registration: Retrospective pooled analysis of NCT01946204, NCT02489318, and NCT02162836

Abstract C37: A Phase 1 open‐label study evaluating pharmacokinetics, safety, and tolerability of linifanib in Japanese patients with solid tumors

2009 ◽  
Author(s):  
Tomohide Tamura ◽  
Noboru Yamamoto ◽  
Hiroshi Nokihara ◽  
Yasuhide Yamada ◽  
Hajime Asahina ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Phase 1 ◽  
Japanese Patients ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Adalimumab in Japanese patients with active ulcers of pyoderma gangrenosum: Twenty‐six‐week phase 3 open‐label study

2020 ◽  
Vol 47 (12) ◽  
pp. 1383-1390
Author(s):  
Kenshi Yamasaki ◽  
Keiichi Yamanaka ◽  
Yiwei Zhao ◽  
Shunsuke Iwano ◽  
Keiko Takei ◽  
...  
Keyword(s):  
Pyoderma Gangrenosum ◽  
Japanese Patients ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Study ◽  
Label Study

CA045-001: A phase III, randomized, open label study of bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO monotherapy in patients (pts) with previously untreated, unresectable or metastatic melanoma (MEL).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS9601-TPS9601 ◽  
Author(s):  
Nikhil I. Khushalani ◽  
Adi Diab ◽  
Paolo Antonio Ascierto ◽  
James M.G. Larkin ◽  
Shahneen Kaur Sandhu ◽  
...  
Keyword(s):  
Checkpoint Inhibitors ◽  
Phase 1 ◽  
Objective Response ◽  
Development Program ◽  
Life Assessment ◽  
Phase Iii ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Study ◽  
Label Study

TPS9601 Background: Standard of care for pts with previously untreated, unresectable or metastatic MEL includes checkpoint inhibitors. Bempegaldesleukin is a CD122-preferential IL-2 pathway agonist designed to provide sustained signaling through the IL-2 βγ receptor to activate and proliferate effector CD8+ T and NK cells over T-regulatory cells in the tumor (Hurwitz ME et al. ASCO GU 2017). In the dose-expansion phase of the phase 1/2 PIVOT-02 trial, bempegaldesleukin + NIVO was well tolerated at the recommended phase 2 dose (RP2D; bempegaldesleukin 0.006 mg/kg IV Q3W + NIVO 360 mg IV Q3W), and previously untreated pts with MEL receiving the RP2D achieved an objective response rate (ORR) of 20/38 (53%) and a complete response of 9/38 (24%) by independent radiology review (Diab A et al. SITC 2018). Presented is the design of the first phase 3 trial in the bempegaldesleukin + NIVO development program in pts with previously untreated, unresectable or metastatic MEL. Methods: This phase 3, randomized, open-label study aims to evaluate the effectiveness, safety, and tolerability of bempegaldesleukin + NIVO (NCT03635983). Eligible pts are ≥12 y with histologically confirmed stage III (unresectable) or stage IV MEL and ECOG PS ≤1 or Lansky PS ≥80% (minors 12-17 y). Pts are ineligible if they have active brain or leptomeningeal metastases, uveal MEL, or a recurrence within 6 mo of completing adjuvant treatment with any approved agent. Pts will be stratified by PD-L1 status (measured using PD-L1 IHC 28-8 pharmDx), BRAF mutation status, and lactate dehydrogenase level, and will be randomized to receive bempegaldesleukin 0.006 mg/kg IV Q3W + NIVO 360 mg IV Q3W or NIVO 360 mg IV Q3W up to 24 mo, or until progression or unacceptable toxicity (N ~ 764). Primary endpoints are ORR and progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS). Secondary endpoints include ORR and PFS by investigator, ORR and PFS by BICR in biomarker population, OS in biomarker population, and safety. Additional endpoints include pharmacokinetics and quality-of-life assessment. Clinical trial information: NCT03635983.

scholarly journals Efficacy, pharmacokinetics, and safety of icatibant for the treatment of Japanese patients with an acute attack of hereditary angioedema: A phase 3 open-label study

2020 ◽  
Vol 69 (2) ◽  
pp. 268-273 ◽  
Author(s):  
Michihiro Hide ◽  
Atsushi Fukunaga ◽  
Junichi Maehara ◽  
Kazunori Eto ◽  
James Hao ◽  
...  
Keyword(s):  
Hereditary Angioedema ◽  
Japanese Patients ◽  
Acute Attack ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Study ◽  
Label Study
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