Letrozole Combined With Anlotinib Hydrochloride in the Treatment of Platinum-resistant Recurrent Ovarian Cancer

NCT04720807 | Unknown Phase 2

• 1 other identifier: XH-21-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Platinum-resistant Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  3 years

Secondary Outcomes (3)

• PFS

  3 years and 5 years

• OS

  3 years and 5 years

• AE

  3 years and 5 years

Study Arms (1)

Letrozole combined with anlotinib hydrochloride

EXPERIMENTAL

Letrozole combined with anlotinib hydrochloride in the treatment of platinum-resistant recurrent ovarian cancer.

Drug: Letrozole combined with anlotinib hydrochloride

Interventions

Letrozole combined with anlotinib hydrochloride DRUG

Letrozole combined with anlotinib hydrochloride in the treatment of platinum-resistant recurrent ovarian cancer.

Letrozole combined with anlotinib hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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); 9. The patient has not been treated with other tyrosine kinase inhibitor (TKI) drugs; 10. The patient has not received tumor endocrine therapy; 11. Patients should have good compliance and the family members agree to cooperate in the survival follow-up.

You may not qualify if:

• 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;
• Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L); those with bleeding tendency (INR is normal without using anticoagulants in 14 days before randomization); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; under the condition of INR ≤ 1.5, Low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day) is permitted for preventive purposes;
• Arteriovenous thrombosis events occurred within one year before screening, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been cured), and pulmonary embolism;
• Those who have a history of psychotropic drug abuse and can't be prevented or have mental disorders;
• Have a history of immunodeficiency, or have a history of organ transplantation;
• According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study;

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Central Study Contacts

Xipeng Wang, Doctor

CONTACT

86-021-25078999; wangxipeng@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: September 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2023
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

CN (1)