Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

PHASE1RecruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

February 28, 2017

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2026

Conditions
Lung Cancer Squamous CellSolid TumorsHead & Neck CancerPancreatic Cancer
Interventions
DRUG

Palbociclib

Palbociclib will be administered orally once daily, 3 weeks out of every 4 in each cycle. The initial dose for part 1 of the study will be 100 mg daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. No pre-medications for palbociclib are required. It should be administered with food.

DRUG

Gedatolisib

Gedatolisib will be administered once weekly on the first day for each of the four weeks during the 4-week cycle. The initial dose for part 1 of the study will be 110 mg. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. No pre-medications for gedatolisib are required.

Trial Locations (3)

02114

NOT_YET_RECRUITING

Massachusetts General Hospital, Boston

02115

NOT_YET_RECRUITING

Beth Israel Deaconess Medical Center, Boston

RECRUITING

Dana Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER

NCT03065062 - Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors | Biotech Hunter | Biotech Hunter