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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04720807
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Platinum-resistant Recurrent Ovarian Cancer Drug: Letrozole combined with anlotinib hydrochloride Phase 2

Detailed Description:
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.The patient has undergone surgery and received ≥2 lines of platinum-containing chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Letrozole combined with anlotinib hydrochloride
Letrozole combined with anlotinib hydrochloride in the treatment of platinum-resistant recurrent ovarian cancer.
Drug: Letrozole combined with anlotinib hydrochloride
Letrozole combined with anlotinib hydrochloride in the treatment of platinum-resistant recurrent ovarian cancer.




Primary Outcome Measures :
  1. ORR [ Time Frame: 3 years ]
    objective response rate


Secondary Outcome Measures :
  1. PFS [ Time Frame: 3 years and 5 years ]
    progression-free survival time

  2. OS [ Time Frame: 3 years and 5 years ]
    Overall survival

  3. AE [ Time Frame: 3 years and 5 years ]
    Adverse event



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older;
  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  3. Histologically diagnosed epithelial ovarian cancer (high-grade serous, clear cell, endometrioid ovarian cancer), fallopian tube cancer or primary peritoneal cancer;
  4. 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;
  5. The patient has measurable lesions with imaging evidence;
  6. The expected survival period ≥ 3 months;
  7. Estrogen receptor (ER) is positive in immunohistochemistry of the first or the last surgical specimens;
  8. Adequate organ function at screening:

1) 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.

Exclusion Criteria:

  1. Patients with other malignant tumors at the same time except for recovery or tumors in a stable state.
  2. Pregnant or breast feeding women;
  3. Patients participated in other drug clinical trials within six months;
  4. Patients with many factors that affect oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
  5. Any bleeding event with a severity level of grade ≥ 3 in CTCAE 4.0 in the 4 weeks before screening;
  6. Patients with known central nervous system metastasis or a history of the metastasis before screening;
  7. 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;
  8. Long-term unhealed wounds or incomplete fractures;
  9. A previous history of organ transplantation;
  10. 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;
  11. 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;
  12. 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;
  13. Those who have a history of psychotropic drug abuse and can't be prevented or have mental disorders;
  14. Have a history of immunodeficiency, or have a history of organ transplantation;
  15. 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;
  16. Have a history of surgery within 28 days;
  17. A history of abdominal fistula or gastrointestinal perforation within 28 days;
  18. People who may receive other systemic anti-tumor treatments or plan to undergo ovarian cancer reduction surgery during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720807


Contacts
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Contact: Xipeng Wang, Doctor 86-021-25078999 wangxipeng@xinhuamed.com.cn

Locations
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China, Shanghai
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Xipeng Wang, Doctor    86-2507-8999    wangxipeng@xinhuamed.com.cn   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04720807    
Other Study ID Numbers: XH-21-001
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs