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New treatment option for Efficacy and Safety
Official title Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
ClinicalTrials.gov ID: NCT04518501
What this study is testing
What is Arsenic trioxide Tablet +Fuzuloparib Capsules?
Arsenic trioxide Tablet +Fuzuloparib Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for efficacy and safety.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ovarian cancer is the leading cause of death from gynecologic tumors in the western world. Most patients have relapses, and responses to subsequent therapies are generally short-lived.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 18-70years old;
- High grade (serous or endometrioid) epithelial ovarian cancers, fallopian tube or primary peritoneal carcinoma;
- Patients received at least two lines of platinum-containing chemotherapy, with recurrence occurring within six months after the last chemotherapy...
- Measurable disease as per RECIST 1.1
- ECOG 0-2;
You likely can't join if
- Prior treatment with PARP inhibitors except under specific conditions: 1. Patients who previously received PARP inhibitor (PARPi) therapy without...
- Patients who had previously received \>20% bone marrow radiotherapy in 1 week;
- Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;
- Uncontrolled systemic infection requiring anti-infective treatment;
- Allergies to the Fuzuloparib or Arsenic Trioxide or their excipients or intolerant patients;
- people with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
See the full eligibility criteria
- 18-70years old;
- High grade (serous or endometrioid) epithelial ovarian cancers, fallopian tube or primary peritoneal carcinoma;
- Patients received at least two lines of platinum-containing chemotherapy, with recurrence occurring within six months after the last chemotherapy dose, or were platinum-refractory patients who have undergone at least...
- Measurable disease as per RECIST 1.1
- ECOG 0-2;
- Life expectancy ≥12 weeks;
- Confirmation of BRCA1/2 mutation status;
- PARPi naive;
- LVEF ≥ 50%;
- Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L;
- Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or \<ULN 5times in the presence of liver metastasis; total...
- The childbearing age people must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative, non-lactating;
- Signed the informed consent;
- Prior treatment with PARP inhibitors except under specific conditions: 1. Patients who previously received PARP inhibitor (PARPi) therapy without disease progression during treatment, but discontinued due to reasons...
- Patients who had previously received \>20% bone marrow radiotherapy in 1 week;
- Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;
- Uncontrolled systemic infection requiring anti-infective treatment;
- Allergies to the Fuzuloparib or Arsenic Trioxide or their excipients or intolerant patients;
- people with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
- Researchers think it is not suitable for enrolling.
The study team makes the final eligibility decision.
Where it's taking place
- Zhejiang, Hangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhejiang, Hangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.