Health TrialsbyHealthPanel

A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.

ConditionPlatinum-resistant Recurrent Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

About this trial

To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who voluntarily participate in this study and sign informed consent form;

Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;

ECOG performance status of 0 or 1；

Expected survival > 12 weeks;

Disqualifiers

Subjects who have received prescribed treatment previously;

Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;

Subjects with known central nervous system metastasis and multiple bone metastasis;

Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;

Trial design

Design model

Parallel

Treatments tested in this trial

  • B013

    Drug

    B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.

  • Paclitaxel

    Drug

    Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.

  • Placebo

    Drug

    Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: B013Experimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

From the date of randomization to the date of progression disease or death , whichever occurred first.

Time frame
Approximately 2 years

Secondary outcomes

1

Objective response rate (ORR)

Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

Time frame
Approximately 2 years
2

Disease control rate (DCR)

DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease.

Time frame
Approximately 2 years
3

Duration of remission (DOR)

DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.

Time frame
Approximately 5 years
4

Overall Survival (OS)

Determination of the overall survival times of all participants.

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator

Source ClinicalTrials.gov
Apply now