Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04711161
Status:
SUSPENDED
Last Update Posted:
2024-01-23
First Post:
2020-12-24
Brief Title:
First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian Primary Peritoneal and Fallopian Tube Cancers
Sponsor:
Green3Bio Inc
Organization:
Green3Bio Inc
Study Overview
Official Title:
Ph 11B Evaluation of the Safety Pharmacokinetics and Efficacy of GRN-300 a Salt-inducible Kinase Inhibitor Alone and in Combination With Paclitaxel in Recurrent Ovarian Primary Peritoneal and Fallopian Tube Cancers
Status:
SUSPENDED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
BusinessCommercial Reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study consists of two parts based on the administration of single-agent GRN-300 or in combination with paclitaxel
Part 1 Phase IA will test the tolerability of continuous twice a day dosing of oral GRN-300 a salt-inducible kinase inhibitor with each cycle consisting of 28 days of treatment The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of dose limiting toxicities DLTs or adverse events
Part 2 Phase IB will test the tolerability of continuous 28-day cycles of GRN-300 in combination with weekly paclitaxel given 3 of 4 weeks per month x 3
Overall duration of the study will be approximately 48 months depending on the rate of enrollment and number of subjects enrolled
Part 1 Phase IA will test the tolerability of continuous twice a day dosing of oral GRN-300 a salt-inducible kinase inhibitor with each cycle consisting of 28 days of treatment The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of dose limiting toxicities DLTs or adverse events
Part 2 Phase IB will test the tolerability of continuous 28-day cycles of GRN-300 in combination with weekly paclitaxel given 3 of 4 weeks per month x 3
Overall duration of the study will be approximately 48 months depending on the rate of enrollment and number of subjects enrolled
Detailed Description:
Part 1 Phase 1A
Primary objectives
Determination of the maximum tolerated dose MTD if applicable and recommended Phase II dose RP2D of GRN-300 in the study population
To investigate the safety and tolerability of repeated 28-day cycles of oral GRN-300 therapy in subjects with persistent or recurrent locally non-resectable or metastatic ovarian fallopian tube and primary peritoneal cancer or other advanced solid tumors
Secondary objectives
To evaluate the pharmacokinetic PK profile of GRN-300 after oral administration of a single dose and at steady state
To estimate the clinical activity of GRN-300 monotherapy by determining the following
Overall response rate ORR per investigator assessment using RECIST v11 defined as the percentage of subjects having a best overall response BOR of complete response CR or partial response PR
Disease control rate DCR per investigator assessment using RECIST v11 defined as the percentage of subjects having a BOR of CR PR or stable disease SD 4 months 4 cycles 28 days each
Part 2 Phase 1B
Primary objectives
Determination of the RP2D of GRN-300 in combination with weekly paclitaxel given 3 of 4 weeks per month x 3 in the study population
To investigate the safety and tolerability of repeated 28-day cycles of daily oral GRN-300 therapy in combination with weekly paclitaxel x 3 in subjects with persistent or recurrent locally non-resectable or metastatic ovarian fallopian tube and primary peritoneal cancer where treatment with paclitaxel is appropriate
Secondary objectives
To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state
To estimate the clinical activity of GRN-300 in combination with paclitaxel by determining the following
Overall response rate ORR per investigator assessment using RECIST v11 defined as the percentage of subjects having a best overall response BOR of complete response CR or partial response PR
DCR per investigator assessment using RECIST v11 defined as the percentage of subjects having a BOR of CR PR or SD 4 months 4 cycles 28 days each
Exploratory Translational Objectives for Both Study Parts
To estimate progression free survival PFS per investigator assessment using RECIST v11 for subjects who received continuous GRN-300 and weekly paclitaxel x 3
Evaluate exploratory biomarkers of target engagement and treatment response
Primary objectives
Determination of the maximum tolerated dose MTD if applicable and recommended Phase II dose RP2D of GRN-300 in the study population
To investigate the safety and tolerability of repeated 28-day cycles of oral GRN-300 therapy in subjects with persistent or recurrent locally non-resectable or metastatic ovarian fallopian tube and primary peritoneal cancer or other advanced solid tumors
Secondary objectives
To evaluate the pharmacokinetic PK profile of GRN-300 after oral administration of a single dose and at steady state
To estimate the clinical activity of GRN-300 monotherapy by determining the following
Overall response rate ORR per investigator assessment using RECIST v11 defined as the percentage of subjects having a best overall response BOR of complete response CR or partial response PR
Disease control rate DCR per investigator assessment using RECIST v11 defined as the percentage of subjects having a BOR of CR PR or stable disease SD 4 months 4 cycles 28 days each
Part 2 Phase 1B
Primary objectives
Determination of the RP2D of GRN-300 in combination with weekly paclitaxel given 3 of 4 weeks per month x 3 in the study population
To investigate the safety and tolerability of repeated 28-day cycles of daily oral GRN-300 therapy in combination with weekly paclitaxel x 3 in subjects with persistent or recurrent locally non-resectable or metastatic ovarian fallopian tube and primary peritoneal cancer where treatment with paclitaxel is appropriate
Secondary objectives
To evaluate the PK profile of GRN-300 and paclitaxel following administration of a single dose of each and at steady state
To estimate the clinical activity of GRN-300 in combination with paclitaxel by determining the following
Overall response rate ORR per investigator assessment using RECIST v11 defined as the percentage of subjects having a best overall response BOR of complete response CR or partial response PR
DCR per investigator assessment using RECIST v11 defined as the percentage of subjects having a BOR of CR PR or SD 4 months 4 cycles 28 days each
Exploratory Translational Objectives for Both Study Parts
To estimate progression free survival PFS per investigator assessment using RECIST v11 for subjects who received continuous GRN-300 and weekly paclitaxel x 3
Evaluate exploratory biomarkers of target engagement and treatment response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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