Safety, Tolerability, Pharmacokinetics and Antitumor Activity of FCN-437c

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

February 14, 2019

Primary Completion Date

December 31, 2021

Study Completion Date

June 30, 2022

Conditions
Breast Neoplasms
Interventions
DRUG

FCN-437c

\- FCN-437c is a selective and potent CDK4/6 dual inhibitor, with broad antitumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic (PK) properties, and acceptable toxicity profile in nonclinical studies.

DRUG

Letrozole 2.5mg

"* Letrozole is the latest generation of aromatase inhibitor. Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.~* Letrozole is used to treat breast cancer in postmenopausal women. It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years."

Trial Locations (1)

Unknown

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

Sponsors
All Listed Sponsors
collaborator

Fudan University

OTHER

collaborator

Zhejiang Cancer Hospital

OTHER

collaborator

Sir Run Run Shaw Hospital

OTHER

lead

Ahon Pharmaceutical Co., Ltd.

OTHER