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Ovarian CancerPhase 3NCT04908787

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

A Phase 3 study testing BD0801, Paclitaxel and Topotecan in people with Ovarian Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 55 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
BD0801, Paclitaxel and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
421 participants
Where
55 sitesChina
Study dates
11 Jun 2021to 11 Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

China55 sites

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

  • Jilin Cancer Hospital

    Changchun, Jilin

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The Second Norman Bethune Hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning

  • Fukuang General Hospital of Liaoning Health Industry Group

    Fushun, Liaoning

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

  • Hainan General Hospital

    Haikou, Hainan

  • Hangzhou Cancer Hospital

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • The First Affiliated Hospital of USTC West District,Anhui Provincial Cancer Hospital

    Hefei, Anhui

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Shandong Cancer Hospital & Institute

    Jinan, Shandong

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong

  • Linyi Cancer Hospital

    Linyi, Shandong

  • Mianyang Central Hospital

    Mianyang, Sichuan

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Nanjing Women and Children's Healthcare Hospital, Women's Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute, Guangxi Cancer Hospital&Medical University School&Cancer Center

    Nanning, Guangxi

  • Nantong Cancer Hospital

    Nantong, Jiangsu

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center

    Shenzhen, Guangdong

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Center Hospital of Gynecology Obstetrics

    Tianjin, Tianjin Municipality

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • Xuzhou Central Hospital(Southeast University Affiliated Hospital)

    Xuzhou, Jiangsu

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

  • The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official 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.

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.

Conditions
Ovarian Cancer
Being tested
BD0801, Paclitaxel, Placebo, Topotecan, doxorubicin liposome
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BD0801Drug

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

  • PaclitaxelDrug

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

  • PlaceboDrug

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

  • TopotecanDrug

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

  • doxorubicin liposomeDrug

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

Study groups in NCT04908787
Study groupRoleWhat they receive
BD0801+chemotherapyExperimentalBD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Receives: Drug: BD0801; Drug: Paclitaxel; Drug: Topotecan; Drug: doxorubicin liposome
Placebo+chemotherapyPlacebo comparatorPlacebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Receives: Drug: Paclitaxel; Drug: Placebo; Drug: Topotecan; Drug: doxorubicin liposome

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 2 year

Secondary outcomes (14)

  1. Overall Survival (OS)

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

    Measured: 2.5 year

  2. PFS by investigator

    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

    Measured: 2 year

  3. Objective Response Rate (ORR) by investigator

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

    Measured: 2 year

  4. Disease Control Rate (DCR) by investigator

    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

    Measured: 2 year

  5. Objective Response Rate (DOR) by investigator

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

    Measured: 2 year

  6. ORR by BIRC

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

    Measured: 2 year

  7. DCR by BIRC

    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

    Measured: 2 year

  8. DOR by BIRC

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

    Measured: 2 year

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

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

    Measured: 2.5 year

  10. Quality Of Life (QoL)

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

    Measured: 2.5 year

  11. Quality Of Life (QoL)

    use EORTC-QLQ-OV28 questionnaire

    Measured: 2.5 year

  12. Serum drug concentrations of BD0801

    Serum drug concentrations of BD0801 will be calculated.

    Measured: 2 year

  13. rate of immunogenicity positive reaction

    Measured: 2 year

  14. duration of immunogenicity positive reaction

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start11 Jun 2021
  3. Primary completion8 Dec 2023
  4. Study completion11 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04908787
Sponsor's protocol ID
SIM-63-OC-301
Status last verified
Sep 2025
First submitted
27 May 2021
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BD0801, Paclitaxel and Topotecan in people with Ovarian Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 55 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival(PFS) by blinded independent review committee(BIRC) (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04908787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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