Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer (ANLOLA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04566952|
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Ovarian and Fallopian Tube Cysts and Neoplasms Neoplasms by Site Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Ovarian Epithelial Ovarian Diseases Adnexal Diseases Genital Diseases, Female Carcinoma Anlotinib PARP Inhibitors BRCA1 Mutation Angiogenesis Antineoplastic Agents BRCA2 Mutation||Drug: Anlotinib Drug: Olaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single-arm, Single-center, Exploratory Phase II Study to Evaluate the Efficacy and Safety of Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer|
|Actual Study Start Date :||October 28, 2020|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||October 1, 2023|
Experimental: Anlotinib combined With dose-reduced olaparib
Anlotinib-olaparib combination therapy until disease progression
Anlotinib will be treated with its minimum dose that is orally 8 mg daily on days 1-14 of a 21-days cycle.
Other Name: FOCUS V
Olaparib will be treated with a total daily dose of 450 or 300mg.
Other Name: Lynparza
- Progression Free Survival (PFS) [ Time Frame: Through study completion, an average of 1 year ]PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.
- Adverse events (AEs) [ Time Frame: Through study completion, an average of 1 year ]Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 to further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants.
- Overall Response Rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.
- Disease Control Rate (DCR) [ Time Frame: Through study completion, an average of 1 year ]DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.
- Overall survival (OS) [ Time Frame: Through study completion, an average of 1 year ]OS is defined as time from randomisation to the first occurrence of death from any cause.
- Time from enrollment to first subsequent treatment (TFST) [ Time Frame: Through study completion, an average of 1 year ]TFST is defined as time from enrollment to first subsequent treatment.
- Quality of Life(QoL) [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 1 year ]EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30) is used to evaluate the quality of life. Scores range from 0 to 100, with higher scores indicating better health-related quality of life
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): NCT04566952
|Contact: Xiaoxiang Chen, MD,PhD||+86 firstname.lastname@example.org|
|Contact: Jing Ni, MD||+86 email@example.com|
|Study Chair:||Xiaoxiang Chen, MD,PhD||Jiangsu Cancer Institute & Hospital|