This is a randomized, open-label study. Patients will be screened within 28 days prior to
the study drug administration. Patients will be randomly assigned to 1 of 2 treatment
arms prior to study drug administration.
Approximately 40 patients will be randomized in a 1:1 ratio to the following treatment
arms:
- GPC-100 in combination with propranolol; or
- GPC-100 in combination with propranolol and G-CSF. To characterize the safety and
clinical activity of GPC-100, the study will employ a Bayesian Optimal Phase II
(BOP2) design to enroll patients for each arm.
All patients will receive via IV 3.14 mg/kg GPC-100 (Burixafor) at least 2 hours prior to
leukapheresis sessions from Days 7-8 (Days 9-11 optional) and 30 mg propranolol (3 x 10
mg tablets) twice daily at 8:30 AM (+/- 1 hr) and 4:00 PM (+/- 1 hr) local time from Days
1 to 8 (and on Days 9-11, if applicable). Patients will administer the first dose of
propranolol onsite on Day 1. Patients will be provided with doses of propranolol for
self-administration at time points when they are not otherwise required to be onsite.
Sites should contact patients via telephone to confirm propranolol administration for
doses administered outside of clinic.
Additional locations may be listed on ClinicalTrials.gov for NCT05561751.
Locations matching your search criteria
United States
Florida
Gainesville
UF Health Cancer Institute - GainesvilleStatus: Active
Name Not Available
This is a randomized, open-label study. Patients will be screened within 28 days prior to
the study drug administration. Patients will be randomly assigned to 1 of 2 treatment
arms prior to study drug administration.
Approximately 40 patients will be randomized in a 1:1 ratio to the following treatment
arms:
- GPC-100 in combination with propranolol; or
- GPC-100 in combination with propranolol and G-CSF. To characterize the safety and
clinical activity of GPC-100, the study will employ a Bayesian Optimal Phase II
(BOP2) design to enroll patients for each arm.
All patients via IV 3.14 mg/kg GPC-100 (Burixafor) at least 2 hours prior to
leukapheresis sessions from Days 7-8 (Days 9-11 optional) and 30 mg propranolol (3 x 10
mg tablets) twice daily at 8:30 AM (+/- 1 hr) and 4:00 PM (+/- 1 hr) local time from Days
1 to 8 (and on Days 9-11, if applicable). Patients will administer the first dose of
propranolol onsite on Day 1. Patients will be provided with doses of propranolol for
self-administration at time points when they are not otherwise required to be onsite.
Sites should contact patients via telephone to confirm propranolol administration for
doses administered outside of clinic.
Only patients randomized to the treatment arm receiving GPC-100 in combination with
propranolol and G-CSF will receive SC injections of 10 microgram/kg/day G-CSF at 5:00 PM
(+/- 3 hr) local time on Days 3 to 7. Patients in this arm will receive G-CSF injections
on Days 8-10 at 5:00 PM (+/- 3 hr) local time only if they will undergo the optional
third-fifth days of mobilization/collection (Days 9-11) at the Investigator's discretion.
On Days 7 and 8 (and on Days 9-11, if applicable), the patient will receive a morning 30
mg propranolol dose (3 x 10 mg tablets) followed immediately by a 3.14 mg/kg dose of
GPC-100 free base (active ingredient) and will start collection of CD34+ stem cells via
leukapheresis.
Lead OrganizationGPCR Therapeutics, Inc.