Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    50
  • sponsor
    Xing Xie
Updated on 25 March 2022

Summary

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. Currently, the population that can benefit from PARPi is mainly focusing on BRCAm, then homologous-recombination deficiency patients. Limited data revealed the ORR was only 3-4% in homologous recombination proficiency patients with PARPi therapy. New treatments are urgently needed to improve patient outcomes.

To explore the efficacy and safety of Fuzuloparib in combination with Arsenic trioxide therapy in platinum-resistance relapsed Ovarian cancer patients.

Description

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. Currently, the population that can benefit from PARPi is mainly focusing on BRCAm, then homologous-recombination deficiency patients. Limited data revealed the ORR was only 3-4% in homologous recombination proficiency patients with PARPi therapy. New treatments are urgently needed to improve patient outcomes.

The investigators' studies have shown that combination therapy with Fuzuloparib and Arsenic trioxide demonstrated a synergistic anti-tumor effect in BRCAness/HR-proficiency ovarian cancer cells:

Firstly, CCK8 and clone formation assays showed that the combination of Fuzuloparib and Arsenic trioxide produced notable tumor cell growth inhibition than either single agent in SKOV3 and CAOV3 cells.

Further, the combination therapy resulted in significantly increased level of γ-H2AX and decreased level of RAD51 by IF.The investigators also found that combination therapy could remarkably induced cell apoptosis, which is associated with induction of cleave-PARP and reduction of p-AKT, when compared with either single drug. (Data not published) Therefore, the investigators hypothesis is that for those platinum-resistance relapsed patients who have received at least twice platinum-based chemotherapy, patients with combinate therapy will get 25% of ORR. And platinum-resistance in combination with Arsenic trioxide therapy is well tolerated.

Details
Condition Efficacy and Safety
Treatment Arsenic trioxide Tablet +Fuzuloparib Capsules
Clinical Study IdentifierNCT04518501
SponsorXing Xie
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

-70years old
High grade (serous or endometrioid) epithelial ovarian cancers, fallopian tube or primary peritoneal carcinoma
Recurrent disease within 6 months of the last receipt of platinum-based chemotherapy
Measurable disease as per RECIST 1.1
ECOG 0-2
Life expectancy ≥12 weeks
Confirmation of BRCA1/2 mutation and homologous recombination 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 bilirubin (TBil) level≤ ULN 1.5 times, or ≤ ULN 2.5times if Gilbert's syndrome are present
The childbearing age subjects 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

Exclusion Criteria

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
Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03
Researchers think it is not suitable for enrolling
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