Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT04711161
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.
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 v1.1 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 v1.1 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 v1.1 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 v.1.1 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 v1.1 for subjects who received continuous GRN-300 and weekly paclitaxel x 3.
* Evaluate exploratory biomarkers of target engagement and treatment response
Study:
NCT04711161
Study Brief:
Protocol Section:
NCT04711161