"Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer (GLACIER)"

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

February 26, 2019

Primary Completion Date

August 30, 2019

Study Completion Date

November 12, 2019

Conditions
Breast Cancer
Interventions
DRUG

Hydroxychloroquine (HCQ)

All patients will receive HCQ at a dose of 600 mg orally twice daily. This dose is the same in both phase Ib and phase II portions of the protocol. Capsules of HCQ are available in 200 mg strength, thus patients will initially start with 3 capsules twice daily for a total of 6 capsules per day. HCQ will be administered in divided doses (BID). When taking HCQ twice daily, the two daily doses should be taken 12 hours apart as close to 9am and 9pm as possible. Patients receiving antacids, sucralfate, cholestyramine, and/or bicarbonate should have the HCQ drug dose administered at least 1 hour before or 2 hours after these medications. Hydroxychloroquine will be obtained from the UPENN Investigational Drug Service (IDS).

DRUG

Gedatolisib

"Gedatolisib will be administered intravenously on a weekly dosing schedule at 150 mg IV.~Within 3 days prior to GED dosing the patient must have an ANC \>1.0 x 109/L and platelet count \> 75 x 109/L. If hematologic toxicity persists, treatment should be delayed by one week and the complete blood cell count with differential and platelet count repeated. Treatment may be delayed for up to 4 consecutive weeks (28 days). If after 28 days of delay all hematologic toxicity has still not resolved to normal and non-hematologic toxicity has not resolved to \<grade 1 then any further treatment with GED should be stopped."

Trial Locations (1)

19104

Abramson Cancer Center of the University of Pennsylvania, Philadelphia

All Listed Sponsors
collaborator

Translational Breast Cancer Research Consortium

OTHER

collaborator

Pfizer

INDUSTRY

collaborator

Hoosier Cancer Research Network

OTHER

collaborator

Breast Cancer Research Foundation

OTHER

lead

Abramson Cancer Center at Penn Medicine

OTHER