Letrozole Combined With Anlotinib Hydrochloride in the Treatment of Platinum-resistant Recurrent Ovarian Cancer: a Prospective, Single-arm, Open Label, Exploratory Phase 2 Clinical Trial.

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country30 target enrollmentSeptember 1, 2020

ConditionsPlatinum-resistant Recurrent Ovarian Cancer

InterventionsLetrozole combined with anlotinib hydrochloride

DrugsLetrozole combined with anlotinib hydrochloride

Overview

Phase: Phase 2
Intervention: Letrozole combined with anlotinib hydrochloride
Conditions: Platinum-resistant Recurrent Ovarian Cancer
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment: 30
Locations: 1
Primary Endpoint: ORR
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a prospective, single-arm, open label, exploratory phase 2 clinical trial, which aims to study the therapeutic effect of letrozole combined with anlotinib hydrochloride in platinum-resistant recurrent ovarian cancer.

Detailed Description

Registry

clinicaltrials.gov

Start Date

September 1, 2020

End Date

September 30, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years of age or older;
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
•Histologically diagnosed epithelial ovarian cancer (high-grade serous, clear cell, endometrioid ovarian cancer), fallopian tube cancer or primary peritoneal cancer;
•The patient has undergone surgery and received ≥2 lines of platinum-containing chemotherapy. During the treatment period of the platinum-containing regimen (from the beginning of the treatment to 1 month after the last chemotherapy), the curative effect is non-PD, and the disease relapse/progress within 6 months after the treatment；
•The patient has measurable lesions with imaging evidence;
•The expected survival period ≥ 3 months;
•Estrogen receptor (ER) is positive in immunohistochemistry of the first or the last surgical specimens;
•Adequate organ function at screening:
•Adequate bone marrow function at screening: Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil ≥1.5×109/L; Platelets ≥80×109/L; 2) Biochemical test: Total bilirubin≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT or AST ≤ 5×ULN; Serum creatinine ≤ 1.5×ULN or endogenous creatinine clearance ≥ 50ml/min (Cockcroft-Gault formula);
•The patient has not been treated with other tyrosine kinase inhibitor (TKI) drugs;

Exclusion Criteria

•Patients with other malignant tumors at the same time except for recovery or tumors in a stable state.
•Pregnant or breast feeding women;
•Patients participated in other drug clinical trials within six months;
•Patients with many factors that affect oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
•Any bleeding event with a severity level of grade ≥ 3 in CTCAE 4.0 in the 4 weeks before screening;
•Patients with known central nervous system metastasis or a history of the metastasis before screening;
•Patients with hypertension who cannot be well controlled by antihypertensive drugs (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg); those with a history of unstable angina; those who are newly diagnosed with angina within 3 months before screening or Myocardial infarction occurred within 6 months before screening; arrhythmia requires long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ II cardiac insufficiency;
•Long-term unhealed wounds or incomplete fractures;
•A previous history of organ transplantation;
•Imaging shows that the tumor has invaded important blood vessels or the researcher has judged that the patient's tumor is highly likely to invade important blood vessels to induce fatal bleeding during treatment;