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

NCT04488107 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2020-07-27

No results posted yet for this study

Summary

This is a multicenter, open, single arm dose escalation and dose expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of FCN-437c alone or in combination with letrozole in women with ER +/ HER2 - advanced breast cancer.

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.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • Ahon Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • Xichun Hu, M.D. · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488107 on ClinicalTrials.gov