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Completed

NCT Number: NCT04908787

A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer

The standard systemic treatment for ovarian cancer is platinum-based chemotherapy. However, majority of patients relapse and eventually progress to platinum resistance. In patients with platinum-resistant or refractory ovarian cancer, effective treatment options are limited and the prognosis is very poor. Angiogenesis is essential for tumor growth and metastasis, and VEGF/VEGF receptor(VEGFR) signaling pathway is the most promising angiogenic target. This study aim to assess the efficacy and safety of the combination BD0801 and chemotherapy in patients with platinum-resistant recurrent ovarian cancer.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female patients, >/=18 years of age;
  • epithelial ovarian, fallopian tube or primary peritoneal cancer;
  • platinum-resistant disease (disease progression within <6 months of platinum therapy)
  • Eastern Cooperative Oncology Group（ECOG）performance status of 0-1

Exclusion criteria

  • non-epithelial tumours
  • ovarian tumours with low malignant potential
  • Received 1 line of systemic therapy for ovarian cancer following platinum resistance and/or > 1 line of non-platinum systemic therapy prior to platinum resistance.
  • prior radiotherapy to the pelvis or abdomen

Treatment and study plan

BD0801

Drug

Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg

paclitaxel

Drug

Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2

Placebo

Drug

Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg

Topotecan

Drug

Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2

doxorubicin liposome

Drug

Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2

Primary outcomes

  1. Progression free survival(PFS) by blinded independent review committee(BIRC)

    Time frame: 2 year

    PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the IRC according to the RECIST 1.1 criteria

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 2.5 year

    OS is the time interval from the date of randomization to death from any cause.

  2. PFS by investigator

    Time frame: 2 year

    PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigator according to the RECIST1.1 criteria

  3. Objective Response Rate (ORR) by investigator

    Time frame: 2 year

    Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria

  4. Disease Control Rate (DCR) by investigator

    Time frame: 2 year

    Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria

  5. Objective Response Rate (DOR) by investigator

    Time frame: 2 year

    Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

  6. ORR by BIRC

    Time frame: 2 year

    Proportion of subjects who have a complete or partial response relative to baseline as assessed by BIRC according to RECIST 1.1 criteria

  7. DCR by BIRC

    Time frame: 2 year

    Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by BIRC according to RECIST 1.1 criteria

  8. DOR by BIRC

    Time frame: 2 year

    Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

  9. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 2.5 year

    Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0

  10. Quality Of Life (QoL)

    Time frame: 2.5 year

    use European Organisation for Research and Treatment of Cance（EORTC）- QLQ-C30 questionnaire

  11. Quality Of Life (QoL)

    Time frame: 2.5 year

    use EORTC-QLQ-OV28 questionnaire

  12. Serum drug concentrations of BD0801

    Time frame: 2 year

    Serum drug concentrations of BD0801 will be calculated.

  13. rate of immunogenicity positive reaction

    Time frame: 2 year

  14. duration of immunogenicity positive reaction

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Shanghai Xianxiang Medical Technology Co., Ltd.

Registry information

Official study title

A Randomized, Double-blind, Phase III Study of BD0801 Injection Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Patients With Recurrent, Platinum-resistant Epithelial Ovarian, Fallopian Tube , or Primary Peritoneal Cancer.

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 1, 2021
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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