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Aribulin Combined With Carboplatin and Bevacizumab in the Treatment of Ovarian Cancer

Sponsor
Second Affiliated Hospital of Guangzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05965141
Collaborator
(none)
38
Enrollment
1
Arm
22
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a prospective phase II, single-center, single-arm clinical study of platinum-sensitive relapsed ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of Aribrine combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive relapsed ovarian cancer.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

This is a phase II prospective, single-center, single-arm clinical study for platinum-sensitive recurrent ovarian cancer. The main objective of this study is to evaluate the efficacy, safety and tolerability of alibulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.

Trial time plan: The inclusion time of the plan: 22 months. Planned trial duration: 24 months.

  1. Experimental drugs: Aribrine mesylate injection, carboplatin, bevacizumab.

  2. Administration regimen: Iribrine mesylate injection: 1.4mg/m2i.v. 30 min, d1 d8, every 21 days; Carboplatin: AUC=5~6 i.v. d1, every 21 days; Bevacizumab: 7.5mg/kg, i.v. 30-90 min,d1, every 21 days. The dose can be adjusted according to the state of the patient.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Prospective Single-arm Clinical Study of Aribulin Combined With Carboplatin and Bevacizumab in the First-line Treatment of Platinum-sensitive Recurrent Ovarian Cancer
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aribulin in combination with carboplatin and bevacizumab

This is a one-arm study without randomization. There was only one trial group of Aribulin combined with carboplatin and bevacizumab.

Drug: Aribulin;carboplatin;bevacizumab
Aribulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer.

Outcome Measures

Primary Outcome Measures

  1. Objective response rate [During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.]

    The proportion of subjects who achieved PR and CR.

Secondary Outcome Measures

  1. Disease control rate [During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.]

    Percentage of subjects who achieved PR, CR, and SD.

  2. Progression-free survival time [During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.]

    The time between the patient's first treatment date and any recorded tumor progression or death from any cause.

  3. Clinical benefit rate [During treatment, imaging examinations were performed ±3 days every 2 cycles and D0±1 days per cycle for CA-125. When the efficacy was evaluated as PR or CR, imaging was performed again at 6 weeks ±3 days.]

    Percentage of subjects who achieved PR, CR, and SD for at least 24 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients with measurable or immeasurable disease (RECIST v1.1) or CA 125 evaluable disease (GCIG criteria) or histologically confirmed diagnosis of recurrent ovarian cancer.

  • First disease recurrence after first-line platinum chemotherapy >6 months.

  • 18 years of age ≤75 years of female.

  • Expected survival ≥ 3 months.

Exclusion Criteria:

  • Partial tumor related symptoms.

  • Partial comorbidity.

  • Subjects developed new secondary malignancies.

  • other.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Second Affiliated Hospital of Guangzhou Medical University

Investigators

  • Study Chair: Jingqi Chen, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Second Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT05965141
Other Study ID Numbers:
  • 2022-LCYJ-YY01
First Posted:
Jul 28, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Bevacizumab
Carboplatin

Study Results

No Results Posted as of Jul 28, 2023