A randomised, partially double-blind, controlled, parallel group study to evaluate the efficacy, safety and tolerability of pumactant 240mg in the prevention of the formation of peritoneal adhesions following abdominal surgery

Start Date01 Apr 2001

Sponsor / Collaborator-

100 Clinical Results associated with Pumactant

100 Translational Medicine associated with Pumactant

100 Patents (Medical) associated with Pumactant

Literatures (Medical) associated with Pumactant

01 Apr 2024·Journal of Clinical Psychology

Treatment of Alec: “History does not have to repeat itself”

Article

Author: Weinberg, Igor

AbstractTreatment of patients with pathological narcissism presents several challenges and there is paucity of published case reports that document meaningful and durable change in patients suffering from this condition. Using descriptive and atheoretical language, this paper presents a treatment of a young man in his transition from young adulthood to middle adulthood while he was negotiating complex residues of his experiences of growing up along with developmental challenges related to work and love. Against the backdrop of these transitions, the patient was working through various aspects of functioning related to pathological narcissism. Initially, given academic pressures and past romantic disappointments, he was confronting issues related to perfectionism, self‐criticism, and avoidance. While he was able to move past some of these dynamics and function academically, later challenges related to becoming an independent adult led to a retreat into an avoidant state of futility and pessimism. Working through painful family dynamics related to not being seen and controlled, along with a deepening attachment in therapy as well as confrontation with realities of his life, led him to take steps toward greater independence. Thereafter, his treatment focused on learning from life experiences such as a newly developed career and romantic life, accepting the complexity of self and others, and tolerating disillusionments.

01 Jan 2023·Frontiers in oncology

Therapeutic drug monitoring guided dosing versus standard dosing of alectinib in advanced ALK positive non-small cell lung cancer patients: Study protocol for an international, multicenter phase IV randomized controlled trial (ADAPT ALEC).

Article

Author: van der Wekken, Anthonie J ; Dingemans, Anne-Marie C ; Timens, Wim ; Hashemi, Sayed M S ; Sikkema, Barend J ; Retèl, Valesca P ; Mathijssen, Ron H J ; Muntinghe-Wagenaar, M Benthe ; Huitema, Alwin D R ; Croes, Sander ; Meertens, Marinda ; Hendriks, Lizza E L ; van Boven, Job F M ; van den Heuvel, Michel M ; de Langen, Adrianus J ; Paats, Marthe S ; Touw, Daan J ; Steeghs, Neeltje ; Schuuring, Ed ; Ter Heine, Rob ; Lopez-Yurda, Marta ; Smit, Egbert F

BackgroundAlectinib is first-line therapy in patients with stage IV non-small cell lung carcinoma (NSCLC) and an anaplastic lymphoma kinase (ALK) fusion. A shorter median progression-free survival (mPFS) was observed when alectinib minimum plasma concentrations during steady state (C_min,SS) were below 435 ng/mL. This may suggest that patients should have an alectinib C_min,SS ≥ 435 ng/mL for a more favorable outcome. This potential target could be attained by using therapeutic drug monitoring (TDM), i.e. adjusting the dose based on measured plasma trough concentrations. Hypothetically, this will increase mPFS, but this has not yet been evaluated in a randomized controlled trial (RCT). Therefore, the ADAPT ALEC trial is designed, with the primary objective to prolong mPFS in NSCLC patients treated with alectinib by using TDM.MethodsADAPT ALEC is a multicenter, phase IV RCT, in which patients aged ≥ 18 years with advanced ALK positive (+) NSCLC eligible for alectinib in daily care are enrolled. Participants will be randomized (1:1 ratio) into intervention arm A (TDM) or B (control), stratified by brain metastases and prior ALK treatments. Starting dose in both arms is the approved flat fixed dose of alectinib 600 mg taken twice daily with food. In case of alectinib C_min,SS < 435 ng/mL, arm A will receive increased doses of alectinib till C_min,SS ≥ 435 ng/mL when considered tolerable. The primary outcome is mPFS, where progressive disease is defined according to RECIST v1.1 or all-cause death and assessed by CT-scans and MRI brain. Secondary endpoints are feasibility and tolerability of TDM, patient and physician adherence, overall response rate, median overall survival, intracranial PFS, quality of life, toxicity, alectinib-M4 concentrations and cost-effectiveness of TDM. Exploratory endpoints are circulating tumor DNA and body composition.DiscussionThe ADAPT ALEC will show whether treatment outcomes of patients with advanced ALK+ NSCLC improve when using TDM-guided dosing of alectinib instead of fixed dosing. The results will provide high quality evidence for deciding whether TDM should be implemented as standard of care and this will have important consequences for the prescribing of alectinib.Clinical trial registrationClinicalTrials.gov, identifier NCT05525338.

01 Mar 2021·European Journal of CancerQ1 · MEDICINE

Sequential therapy of crizotinib followed by alectinib for non-small cell lung cancer harbouring anaplastic lymphoma kinase rearrangement (WJOG9516L): A multicenter retrospective cohort study

Q1 · MEDICINE

Article

Author: Nakamura, Atsushi ; Yamanaka, Takeharu ; Kobayashi, Haruki ; Yokoi, Takashi ; Hayashi, Hidetoshi ; Akamatsu, Hiroaki ; Yamamoto, Nobuyuki ; Tamura, Atsuhisa ; Seto, Takashi ; Hataji, Osamu ; Kubo, Akihito ; Azuma, Koji ; Fujimoto, Daichi ; Fukui, Tomoya ; Suzuki, Kensuke ; Tanaka, Kentaro ; Oya, Yuko ; Miura, Satoru ; Sakata, Shinya ; Ito, Kentaro ; Hontsu, Shigeto ; Nishino, Kazumi ; Watanabe, Satoshi ; Bessho, Akihiro ; Aoki, Takuya ; Daga, Haruko ; Yokoyama, Toshihide ; Hirano, Katsuya ; Maeno, Ken ; Hattori, Yoshihiro ; Nakagawa, Kazuhiko ; Kozuki, Toshiyuki ; Okuno, Motoyasu ; Mori, Masahide ; Azuma, Koichi

BACKGROUNDThe data of sequential therapy of anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) in clinical practice have been limited.METHODSWe reviewed the clinical data of patients with ALK-rearranged non-small cell lung cancer who received crizotinib (CRZ) or alectinib (ALEC) between May 2012 and December 2016. Patients were divided into two groups based on the first-administered ALK-TKI, the CRZ or ALEC group. The combined time-to-treatment failure (TTF) was defined as the sum of the 'TTF of CRZ' plus the 'TTF of ALEC' if patients were treated with CRZ followed by ALEC in the CRZ group. The primary end-point is the comparison between the combined TTF and the TTF of ALEC in the ALEC group.RESULTSOf 864 patients enrolled from 61 institutions, 840 patients were analysed. There were 535 of 305 patients in the CRZ/ALEC groups. The combined TTF in the CRZ group was significantly longer than TTF in the ALEC group (median, 34.4 versus 27.2 months; hazard ratio [HR], 0.709; P = 0.0044). However, there was no significant difference in overall survival (OS) between the patients who received ALEC after CRZ in the CRZ group and the patients in the ALEC group (median, 88.4 months versus. not reached; HR, 1.048; P = 0.7770). In the whole population, the CRZ group had a significantly shorter OS than the ALEC group (median, 53.6 months versus not reached; HR, 1.821, P < 0.0001).CONCLUSIONThe combined TTF in the CRZ group was significantly longer than the TTF in the ALEC group; however, OS benefit of sequential therapy against ALEC as the first ALK-TKI was not shown.

100 Deals associated with Pumactant

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	GB	Britannia Pharmaceuticals Ltd.	-
Respiratory Distress Syndrome, Adult	Phase 3	-	airPharma LLC	-
Respiratory Distress Syndrome, Adult	Phase 3	-	Genus Pharmaceuticals Ltd.	-
Surgical Adhesion	Phase 3	GB	Britannia Pharmaceuticals Ltd.	-
Surgical Adhesion	Phase 3	AU	Britannia Pharmaceuticals Ltd.	-

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