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

Simcere

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: BD0801; Drug: Paclitaxel; Drug: doxorubicin liposome; Drug: Topotecan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04908787

SIM-63-OC-301

Details and patient eligibility

About

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.

Enrollment: 421 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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421 participants in 2 patient groups, including a placebo group

BD0801+chemotherapy

Experimental group

Description:

BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.

Treatment:

Drug: Topotecan

Drug: doxorubicin liposome

Drug: Paclitaxel

Drug: BD0801

Placebo+chemotherapy

Placebo Comparator group

Description:

Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.

Treatment:

Drug: Placebo

Drug: Topotecan

Drug: doxorubicin liposome

Drug: Paclitaxel