Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03736122
Status:
UNKNOWN
Last Update Posted:
2018-11-08
First Post:
2018-10-30
Brief Title:
A Study of Syngenon BSG-001 for Inhalation in Subjects With Malignant Pleural Effusion andor Malignant Ascites
Sponsor:
BioSyngen Pte Ltd
Organization:
BioSyngen Pte Ltd
Study Overview
Official Title:
A Phase IIIa Study of Syngenon BSG-001 for Inhalation in Subjects With Malignant Pleural Effusion andor Malignant Ascites
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This study is a phase 12a 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None