Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer (TRC105)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
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): 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|