Palbociclib With Cetuximab and IMRT for Locally Advanced Squamous Cell Carcinoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

July 19, 2017

Primary Completion Date

March 11, 2024

Study Completion Date

December 31, 2024

Conditions
Head and Neck CancerLocally Advanced
Interventions
DRUG

Palbociclib

Dose Level -1: 100 mg oral every other day 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).

DRUG

Palbociclib

Dose Level 1: 75 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).

DRUG

Palbociclib

Dose Level 2: 100 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).

DRUG

Palbociclib

Dose Level 3: 125 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).

DRUG

Cetuximab

All dose levels: 400 mg/m2 IV at 7 days before (day -7) starting radiation and then 250 mg/m2 IV weekly for 7 weeks.

RADIATION

Intensity Modulated Radiation Therapy

5 days on/2 days off with a total dose of 70 Gy for 33-35 fractions.

Trial Locations (1)

10400

Faculty of Medicine, Ramathibodi Hospital, Bangkok

All Listed Sponsors
lead

Mahidol University

OTHER

NCT03024489 - Palbociclib With Cetuximab and IMRT for Locally Advanced Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter