Status:
UNKNOWN
Arsenic Trioxide in Recurrent and Metastatic Ovarian Cancer and Endometrial Cancer With P53 Mutation
Lead Sponsor:
Ruijin Hospital
Conditions:
Ovarian Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is a Single-center, open, single-arm and non-randomized clinical trial in China. The aim of this study is to evaluate the efficacy, safety, and tolerability of Arsenic trioxide for injectio...
Detailed Description
The P53 mutation plays an important role in the development of ovarian cancer and endometrial cancer, which has been found to occur in more than 95% of high grade serous ovarian cancers, 25% of the en...
Eligibility Criteria
Inclusion
- Participants (or their legal Representatives/guardians) are required to sign an informed consent form, indicating that they understand the objectives of the study, necessary procedures and are willing to participate in the study.
- Women over 18 years of age with histologically confirmed recurrence or metastasis of ovarian cancer or endometrial cancer.
- Laboratory confirmed P53 Gene Mutation.
- Previously received no less than 1-line treatment in the past with disease recurrence or progression.
- Disease Recurrence or progression (based on clinical, tumor markers, or imaging findings) occurs less than 6 months after the last treatment.
- At least one measurable lesion was confirmed by independent central imaging, according to RECIST V1.1, or elevation of tumor markers.
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) score 0-1
- Estimated survival time ≥12 weeks.
- Sexually active, fertile subjects and their spouses have to agree to contraception throughout the study and within 90 days of the last study drug being given.
Exclusion
- Hematopoiesis or organ dysfunction (blood products, such as blood transfusions, should not be used until less than 14 days before the first dose of the drug is studied) .
- ANC (Absolute neutrophil count）\<1.5×10\^9/L.
- HGB（Hemoglobin）\< 8 g/dL.
- PLT (Platelet）\<100×10\^9/L.
- TBIL (Total bilirubin）\>1.5 × ULN（Upper limit of normal)
- AST（Aspartate transferase）and/or ALT（Alanine aminotransferase）\>3 × ULN，\>5 × ULN in subjects with liver metastases.
- Cr (Creatine) \>1.5 × ULN.
- INR (International normalized ratio)\>1.5 × ULN，aPTT (activated Partial thromboplastin time) \>1.5 × ULN, (INR is only applicable to subjects who have not received anticoagulation therapy).
- Radiation therapy less than 4 weeks before the first dose of study drug, or chemotherapy, biotherapy, endocrine therapy or small molecule targeted therapy before the first dose of study drug (elution ≥5 half-lives can be grouped).
- Toxic response to previous antitumor therapy has not yet recovered to 1 grade, according to NCI CTCAE V5.0, except for alopecia.
- Clinically significant active infection.
- Clinically significant active bleeding.
- Alcoholism or drug addiction.
- A history of clinically significant liver disease, including active viral or other hepatitis, alcohol abuse, or cirrhosis, except in subjects with a prior hepatitis which is inactive, confirmed by PCR (Polymerase chain reaction).
- HIV (Human immunodeficiency virus) infection.
- NYHA (The New York Heart Association) Class II or above Heart failure; History of myocardial infarction or unstable Angina within 6 months before treatment; History of myocardial infarction or unstable angina within 6 months before treatment.
- Pregnancy, breastfeeding or planning to become pregnant during the study period.
- Bowel obstruction within 12 weeks before the first dose of the drug.
- Received major surgery within 4 weeks before the first dose of the study drug.
- Received oral or intravenous Glutathione within 3 weeks before the start of treatment.
- Known to be allergic or hypersensitive to any ingredient of Arsenic trioxide.
- Subjects with poor adherence, or with any unsuitability to participate in this trial; Subjects with any clinical or laboratory abnormalities were not eligible to participate in this clinical study.
Key Trial Info
Start Date :
June 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04489706
Start Date
June 28 2020
End Date
November 1 2022
Last Update
July 28 2020
Active Locations (1)
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1
Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200011