A Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites
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|ClinicalTrials.gov Identifier: NCT03736122|
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Malignant pleural effusion and/ or malignant ascites is generally defined by presence of malignant cells in the effusion fluid. The first-line therapies are mostly intrusive, medically demanding and inefficient, and therefore, it is important to study and develop new therapeutic option to address the unmet need.
This protocol for BSG-001 is developed for the treatment of malignant pleural effusion and/ or malignant ascites. BSG-001 is an immune-modulator primarily exerts its effect via Toll-like receptor.
The purpose of this study is to assess the safety and tolerability of BSG-001. All eligible subjects will receive BSG-001 for at least 12 weeks (3 cycles).
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Effusion Malignant Ascites||Drug: BSG-001||Phase 1 Phase 2|
This study is a phase 1/2a, single arm study with main purpose to evaluate the safety, tolerability and efficacy of BSG-001 in subjects with cancer that causes an abnormal amount of fluid to collect between the thin layers of tissue (pleura) lining the outside of the lung and the wall of the chest cavity, namely malignant pleural effusion and/ or subjects with cancer that causes the accumulation of fluid in the peritoneal cavity, causing abdominal swelling, namely malignant ascites.
The study aims to recruit 9 - 18 subjects in phase 1, and once the safety, tolerability and the preliminary efficacy of BSG-001 reach an optimal target exposure for recommended dose (RD), phase 2a will be opened for enrolment of approximately 40 subjects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Inhalation route, daily
BSG-001 is in solution form, 4mg per vial (2mg/mL) with Inhalation as route of administration using nebulizer.
BSG-001 will be administrated as an approximately 5 - 30 minutes inhalation session daily for 3 cycles (in repeated 28 days cycle).
- Safety and Tolerability of BSG-001 assessed with incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs [ Time Frame: From start of treatment throughout 12 weeks dosing ]Treatment-Emergent Adverse Events (AEs) and Serious AEs will be assessed by CTCAE v4.0 or higher version
- Efficacy of BSG-001 assessed with change in fluid volume of Malignant Pleural Effusion and/or Malignant Ascites [ Time Frame: From start of treatment throughout 12 weeks dosing, until disease progression and onward survival follow up up to 6 months or study completion, whichever came first. ]Efficacy of BSG-001 will be assessed with change in frequency and total change volume (for subjects require paracentesis and/or thoracentesis) and assessed by radiographic imaging (CT/ ultrasound) (for subjects without catheter drainage)
- Recommended dose (RD) of BSG-001 [ Time Frame: Start of treatment throughout 28-day DLT dosing period ]RD will be assessed with incidence of BSG-001-related Adverse Events Grading during the dose limiting toxicity (DLT) period
- Subjects' reported quality of life [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-30), version 3] [ Time Frame: From screening/ baseline, followed by Day 1 of every cycle prior to other procedures (each cycle is 28 days) for 3 cycles. ]Reported quality of life will be assessed through EORTC QLQ-30 questionnaire score change from baseline, by a four-point scale (first 28 questions) and a 7-point scale (last 2 questions) total of 30 questions, where higher score represents higher (better) response level. Calculation is based on linear transformation to standardise the raw score, so that scores range from 0 to 100.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736122
|Contact: Grace Khoo Koay||(65) 6926 email@example.com|
|Australia, South Australia|
|Flinders Medical Centre||Not yet recruiting|
|Adelaide, South Australia, Australia, 5042|
|Contact: Kathrina Bartolay +61 8 8404 2201 Kathrina.Bartolay@sa.gov.au|
|Principal Investigator: Anand Rose, MD|
|Study Director:||Lietao Li, MD||BioSyngen Australia Pty Ltd|