A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

October 19, 2012

Primary Completion Date

March 4, 2016

Study Completion Date

October 25, 2018

Conditions
NeoplasmsBreast Neoplasms
Interventions
DRUG

PD-0332991

PD-0332991 (100 mg or 125 mg) will be orally administered once a day for 3 weeks followed by 1 week off treatment, in the morning on an empty stomach. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.

DRUG

PD-0332991

PD-0332991, 125 mg, will be orally administered with food once a day for 3 weeks followed by 1 week off treatment. PD-0332991 will be administered once a day together with letrozole. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.

DRUG

letrozole

Letrozole, 2.5 mg, will be orally administered once a day in continuous daily dosing together with PD-0332991. Dose reduction of letrozole is not permitted, but dosing interruptions for letrozole-related toxicity are allowed as per investigator's medical judgement.

DRUG

PD-0332991

PD-0332991, 125 mg, will be orally administered with food once a day for 3 weeks followed by 1 week off treatment. PD-0332991 will be administered once a day together with letrozole. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.

DRUG

letrozole

Letrozole, 2.5 mg, will be orally administered once a day in continuous daily dosing together with PD-0332991. Dose reduction of letrozole is not permitted, but dosing interruptions for letrozole-related toxicity are allowed as per investigator's medical judgement.

Trial Locations (16)

464-8681

Aichi Cancer Center Hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

862-8655

Kumamoto Shinto General Hospital, Kumamoto

362-0806

Saitama Cancer Center, Kita-adachi-gun

104-0045

National Cancer Center Hospital, Chuo-Ku

260-8717

Chiba Cancer Center, Chiba

791-0280

National Hospital Organization Shikoku Cancer Center, Ehime

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

892-0833

Hakuaikai Medical Corporation Sagara Hospital, Kagoshima

860-8556

Kumamoto University Hospital, Kumamoto

862-8505

Kumamoto City Hospital, Kumamoto

606-8507

Kyoto University Hospital, Kyoto

020-8505

Iwate Medical University Hospital, Numakunai

540-0006

National Hospital Organization Osaka National Hospital, Osaka

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY