Palbociclib and anastrozole for patients with estrogen receptor positive recurrent or metastatic endometrial cancer; a single arm phase 2 study.

All India Institute of Medical Sciences Dr BRA IRCH New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

试验速览

暂无简介。

•1.Histologically confirmed advanced (Stage 4B) or recurrent endometrioid endometrial cancer 2.Estrogen receptor (ER) positive, defined as more than or equal to 1% by IHC 3.Post menopausal women 4.ECOG PS 0-2 5.Measurable or evaluable disease with at least one target lesion which could be used for response evaluation as per RECIST 1.1 criteria. 6.The patient may have received adjuvant chemotherapy for stage 1 or 2 disease previously 7.The patient may have received any lines of chemotherapy for primary advanced disease (stage 3 or 4) or relapsed disease 8.The patient may have received external beam radiotherapy, brachytherapy or surgery 9.The patient may have received endocrine therapy before including medroxyprogesterone acetate/ megestrol or tamoxifen. 10.Adequate organ function: Hb more than or equal to 8g/dL, ANC more than or equal to 1000/uL and platelets > 100000/mm3, serum bilirubin <1.5 times institutional normal, AST/ALT <3 times ULN ( <5 if liver mets present) and ALP <3 times ULN ( <5 if liver mets present), serum creatinine <2 mg/dL; eGFR >45mL/min 11.Written informed consent

•1.Non endometrioid adenocarcinomas, sarcomas, small cell carcinoma with Neuroendocrine differentiation or non- epithelial cancers
•2.Patient with another malignancy before entering the study or a concomitant malignancy.
•3.Prior use of CDK 4/6 or aromatase inhibitors
•4.Uncontrolled severe comorbidities eg uncontrolled hypertension, cardiac arrythmias, unstable angina, MI Within 6 months, congestive heart failure > NYHA III, severe PAD, CTP B or C chronic liver disease, GI disorders that will impair the absorption of the study drug etc.
•5.Hypersensitivity of the drugs in trial
•6.Active chromic hepatitis B or C infections
•7.CNS involvement

发起方

All India Institute of Medical Sciences Dr BRA IRCH New Delhi