Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT02345265|
Recruitment Status : Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : October 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Serous Adenocarcinoma High Grade Ovarian Serous Adenocarcinoma Ovarian Endometrioid Tumor Primary Peritoneal Serous Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Drug: Cediranib Maleate Drug: Olaparib Other: Questionnaire Administration||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Olaparib and Cediranib for the Treatment of Recurrent Ovarian Cancer|
|Actual Study Start Date :||December 4, 2015|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Treatment (olaparib and cediranib maleate)
Patients receive olaparib PO BID and cediranib maleate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cediranib Maleate
Other: Questionnaire Administration
- Progression-free survival [ Time Frame: Interval from start of treatment to documented disease progression per Response Evaluation Criteria in Solid Tumors or death from any cause, whichever occurs first, assessed up to 1 year ]Will be summarized using the Kaplan-Meier product-limit estimator with 95% confidence bands derived using Greenwood's formula.
- Objective response rate (platinum-resistant cohort) [ Time Frame: Up to 1 year ]Will be defined as confirmed complete response or partial response under Response Evaluation Criteria in Solid Tumors 1.1. Clinical activity will be determined using objective response rate.
- Biomarker signature development [ Time Frame: Up to 30 days post-treatment ]Will summarize the distribution of all candidate markers using descriptive statistics and non-parametric tests of their association with patient and disease characteristics. Biomarker profiles will be explored using unsupervised hierarchical clustering of all analytes and patients. The association of each candidate marker to progression-free survival will be evaluated by Cox proportional hazard models using a two-sided alpha = 0.05, while estimating the false discovery rate for any sets of identified markers by the Benjamini-Hochberg step-up procedure.
- Overall survival [ Time Frame: Up to 1 year ]Will be summarized using the Kaplan-Meier product-limit estimator with 95% confidence bands derived using Greenwood's formula.
- Genetic alterations [ Time Frame: Baseline ]Will be detected by the BROCA-homologous recombination assay. Descriptive statistics will be used to summarize the genetic alterations detected by the BROCA-homologous recombination assay and Bioinformatics Pipeline. The prevalence of each genetic alteration will be reported overall, and within stratum defined by platinum-sensitive and platinum-resistant disease using binomial exact 95% confidence intervals. The primary analysis will associate BRCA mutations (germline or somatic) and other homologous recombination gene mutation (as a pooled group) with/against progression-free survival as a time-to-event endpoint, using Kaplan-Meier product-limit estimates and stratified logrank test using a two-sided alpha of 0.05.
- Change in circulating endothelial cells/circulating endothelial precursor cells [ Time Frame: Baseline to day 3 ]Will determine if there is an association between levels of circulating endothelial cells at baseline, or the change in circulating endothelial cells from baseline to day 3, and progression-free survival in patients receiving cediranib maleate/olaparib trial, and to determine if there are significant changes from baseline to day 3 in the levels of circulating endothelial cells. Will use a paired t-test. In addition, if the paired differences in values are not normally distributed (p < 0.05 by a Shapiro-Wilk test), then a Wilcoxon signed rank test will be used instead of a paired t-test.
- Prevalence of genetic alteration using whole exome sequencing [ Time Frame: Baseline ]The prevalence of each genetic alteration will be reported overall, and within platinum-sensitive and platinum-resistant cohorts using binomial exact 95% confidence intervals. Exploratory analyses will associate alterations of a single-gene against progression-free survival as a time-to-event endpoint, using Kaplan-Meier product-limit estimates and logrank test using a nominal two-sided alpha of 0.05.
- Perceived usability and satisfaction of ecediranib-olaparib application from patients [ Time Frame: Up to 1 year ]Significance testing of data from patients and healthcare professionals will be done using a one tailed Wilcoxon signed rank test (alpha = 0.05).
- Perceived usability and satisfaction of ecediranib-olaparib application from health care professionals [ Time Frame: Up to 1 year ]Significance testing of data from patients and healthcare professionals will be done using a one tailed Wilcoxon signed rank test (alpha = 0.05).
- Ecediranib-olaparib application web portal metrics [ Time Frame: Up to 1 year ]Web portal metrics will be summarized using descriptive statistics. The metrics will include: number of patients who accessed the app, number of diarrhea events reported, % blood pressure values entered compared to the % expected, number of follow-up blood pressure measures entered compared to the number recommended, number and type of blood pressure events reported, average duration of blood pressure event and diarrhea event in days, number of other symptoms reported (headache, change in vision, shortness of breath, chest pain, uncontrolled diarrhea, cramping, blood in stool), number and type of email alerts generated to the study team.
- Incidence of ecediranib-olaparib application user support call [ Time Frame: Up to 1 year ]User support calls will be summarized including: number of calls and the reason for contacting ecediranib-olaparib application user support (patients and study team).
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): NCT02345265
|Principal Investigator:||Joyce F Liu||Dana-Farber - Harvard Cancer Center LAO|