BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer
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|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.
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): 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|