BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT01669798|
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer||Drug: BIBF 1120||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 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|
|Actual 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
- Percentage of Patients Who Survive Progression-free [ Time Frame: 6 months ]Measure of Progression Free Survival (PFS) by the percentage 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 (Response Evaluation Criteria in Solid Tumors) 1.1 [ Time Frame: 1 year ]Evaluating the percentage of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.
- Duration of Progression-Free Survival [ Time Frame: Through study completion, on average 2 years ]The duration of progression-free survival and overall survival measured in months; 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 ]The proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria which is: "A response according to CA 125 has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days.".
- 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.
- Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response [ Time Frame: 1 year ]Correlating baseline and on treatment levels of additional growth factors measured in picograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment
- Coagulation and Endothelial Cell Activation Markers [ 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.
- VEGF Levels Correlated With Treatment Outcome [ Time Frame: 1 year ]Baseline levels of VEGF were correlated with treatment outcome. Results are stratified in groups: "Partial Response (PR) or Stable Disease (SD)" and "Progressive Disease (PD)"
- Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response [ Time Frame: 1 year ]Correlating baseline and on treatment levels of additional growth factors measured in nanograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment
- Concentration of VCAM-1 Reported as a Function of Treatment Response [ Time Frame: 1 year ]Correlating baseline and on treatment levels of VCAM-1 measured in micrograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment
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|