Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03509246|
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasm Epithelial High Grade Serous Carcinoma||Drug: Pegylated liposomal doxorubicin plus Bortezomib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial to Evaluate the Efficacy of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer|
|Actual Study Start Date :||May 15, 2018|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Experimental: Pegylated liposomal doxorubicin plus Bortezomib combination
At BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination therapy for six cycles.
Drug: Pegylated liposomal doxorubicin plus Bortezomib
Pegylated liposomal doxorubicin 40mg/m2 subcutaneous for 60 - 90 minutes at day 4 plus Bortezomib 1.3mg/m2 subcutaneous injection at day 1,4,8,11 for 6 cycles
- Overall response rate [ Time Frame: up to 6yr ]In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2
- Partial response rate [ Time Frame: up to 6yr ]The percentage of patients who received a confirmed treatment response over a partial response according to the RECIST criteria version 1.1 in the modified ITT analysis group. The evaluation is based on the researchers of each participating organization.
- Complete remission rate [ Time Frame: up to 6yr ]The proportion of subjects who had a confirmed complete response according to RECIST criteria version 1.1 in the modified ITT analysis group
- Progression-free survival [ Time Frame: up to 2yr ]Patients who have recurred disease after the end of the administration are identified and measured.
- Overall survival [ Time Frame: up to 6yr ]Patients who died from illness after the start of treatment were identified and measured.
- Response period [ Time Frame: up to 5yr ]duration of objective response period
- Quality of life [ Time Frame: up to 6yr ]Evaluation via Physicians Global Assessment to measure the quality of life and pain descriptive diary.
- Adverse drug reactions [ Time Frame: up to 6yr ]To be evaluated according to NCI CTCAE version 4.03 Frequency of occurrence of each drug adverse reaction and 95% confidence interval, grade 3 or higher, the frequency of adverse drug events and 95% confidence interval.
- Genetic susceptibility assessment [ Time Frame: up to 6yr ]Response rate in subjects with CCNE1 amplification.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509246
|Contact: Kidong Kimfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Bundang Hospital||Recruiting|
|Seongnam Si, Gyenggi DO, Korea, Republic of, 463707|
|Contact: KIDONG KIM, MD 82-31-787-7262 KIDONG.KIM.MD@GMAIL.COM|
|Principal Investigator: KIDONG KIM, MD|