Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer (TRC105)
|ClinicalTrials.gov Identifier: NCT01326481|
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: TRC105 Drug: Capecitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
All patients received TRC105 + capecitabine
- Determine Maximum Tolerated Dose of TRC105 in Combination with Capecitabine [ Time Frame: 1.5 years ]Assess safety and dose limiting toxicity by dose cohort.
- TRC105 pharmacokinetic concentrations [ Time Frame: 1.5 years ]Peak and trough concentrations will be evaluated.
- Immune response to TRC105 [ Time Frame: 1.5 years ]Serial blood samples will be tested for immune response to TRC105.
- Objective response according to RECIST 1.1 [ Time Frame: 1.5 years ]The best response according to RECIST 1.1 for each patient with measurable disease who received at least one dose of study drug will be listed by cohort and tumor type
- Angiogenic biomarker sample analysis [ Time Frame: 1.5 years ]Serial blood samples will be tested for change in angiogenic biomarkers.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326481
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3300|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14201|