BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT01669798|
Recruitment Status : Active, not recruiting
First Posted : August 21, 2012
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer||Drug: BIBF 1120||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of BIBF 1120 in the Treatment of Bevacizumab-Resistant, Persistent, or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||September 10, 2017|
|Estimated Study Completion Date :||February 2018|
Experimental: BIBF 1120
BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.
Drug: BIBF 1120
PO 200mg BID
- Progression Free Survival [ Time Frame: 6 months ]To assess the activity of BIBF 1120 as measured by the proportion of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Objective Tumor Response via RECIST 1.1 [ Time Frame: 1 year ]To determine the proportion of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.
- Duration of Progression-Free Survival [ Time Frame: 1 year ]To characterize the duration of progression-free survival and overall survival; Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.
- Objective Tumor Response Based on GCIG CA-125 Criteria [ Time Frame: 1 year ]To determine the proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria.
- VEGF Levels Correlated With Treatment Outcome [ Time Frame: 1 year ]To measure baseline levels of VEGF and correlate with treatment outcome
- Additional Growth Factor Correlation with Treatment Response [ Time Frame: 1 year ]To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment
- Coagulation and Endothelial Cell Activation Markers [ Time Frame: 1 year ]To measure baseline and on treatment levels of coagulation and endothelial cell activation markers that may predict thrombotic or bleeding risks related to treatment
- Adverse Event Frequency and Severity [ Time Frame: 1 year ]To determine frequency and severity of adverse events as assessed using NCI Common Toxicity Criteria version 4.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669798
|United States, North Carolina|
|Duke Cancer Institute|
|Durham, North Carolina, United States, 27710|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Virginia Oncology Associates|
|Norfolk, Virginia, United States, 23502|
|Principal Investigator:||Angeles A Secord, MD||Duke University|