A Phase 2 interventional study of Apatinib and Etoposide in Ovarian Cancer, sponsored by Yang Zhijun. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-29.
Sponsored by Yang Zhijun · Phase 2, Interventional, and Treatment
It is a prospective multi-center trial, platinum-resistant ovarian cancer patients will be randomized in two groups, one group will be treated with Apatinib plus Etoposide, the other will be treated with Etoposide alone. It is aimed to see the efficacy and safety of Apatinib plus Etoposide for the platinum-resistant ovarian cancer patients
It is a randomized controlled trial, the aim is to see the efficacy and safety of Apatinib plus Etoposide treating platinum-resistant ovarian cancer. The main primary end point is DCR (disease control rate), the secondary endpoint is Duration of response（DOR），overall survival (OS), time to progression (TTP)，quality of life (QoL, according to EORTC QLQ-C30).The key safety indicators include the patients' vital signs, laboratory indicators, adverse events(AE),serious adverse events.
The data collection duration is from the day ICF assigned to the day(30 days after the end of the last medication).From the day ICF signed to the end of the study, all adverse events were recorded in the CRF. The severity of the adverse events will be evaluated according to the NCI CTCAE 4.0 standard.Each patient will receive a planned visit and specific data at different points will be recorded in the visit.
The patients will be followed up after quitting the trial because of disease progression or intolerance. The following parameters were recorded during follow-up: disease recurrence,metastasis,death time,SAE occurred during the study; survival (available with telephone follow-up, record required).
Adverse events that have not been recovered when the drug is discontinued should be tracked and finalized. All patients should undergo a 30-day follow-up after the last medication to find any new adverse events.
All cases should be recorded carefully and completely, the investigator should be responsible for the authenticity of the center's data.
During the clinical trial, the inspector should send the CRF to the data management unit (in batches), the data administrator will carry out the independent double entry, and carry out the double verification.
The trial as an exploratory test, using a small sample comparison, the test plans to enroll a total of 60 cases.
The statistical analysis plan includes case analysis,demographic data and baseline analysis,efficacy analysis and safety analysis.All statistical tests will be performed on both sides, the difference between the tests was considered statistically significant with a P value less than or equal to 0.05,
Baseline routine blood test and biochemical indicators meet the following criteria:
Exclusion Criteria:
Apatinib,500mg,PO.QD, continuous administration Etoposide,100mg, PO.QD，D1-D10, Q3W
Drug: Apatinib · Drug: Etoposide
Etoposide,100mg, PO.QD，D1-D10, Q3W
Drug: Etoposide
Apatinib, 500mg,po qd for continuous administration
Also known as: Aitan
Etoposide,100mg, PO.QD，D1-D10, Q3W
Disease Control Rate
the proportion of patients who had a best response rating of complete response, partial response, or stable disease
Time frame: through study completion, an average of 1.5 years
Duration of Response
the time course from the first time tumor assessed as CR or PR to the first time tumor assessed as progressive disease or death
Time frame: through study completion, an average of 1.5 years
Overall Survival
From the beginning of randomization to the cause of death for any reason
Time frame: through study completion, an average of 3 years
Time to Progression
From randomization to the onset of disease progression or death
Time frame: through study completion, an average of 1.5 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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