Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
|ClinicalTrials.gov Identifier: NCT01507545|
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : September 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer Colorectal Cancer||Drug: MORAb-004 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-controlled Study of the Efficacy & Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects With Chemorefractory Metastatic Colorectal Cancer|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||December 2013|
|Active Comparator: MORAb-004||
MORAb-004 8mg IV per kg once a week
|Placebo Comparator: Placebo||
Placebo - normal saline IV once a week
- Progression-free survival [ Time Frame: 16 wks after last patient enrolled ]after 107 subjects have experienced disease progression or died prior to exhibiting disease progression
- Timeframe between first treatment until death for all subjects [ Time Frame: 20 months ]Overall survival will be measured from first treatment until time to event (death).
- Number of subjects with adverse events [ Time Frame: 20 Months ]Safety and tolerability will be measured by number of adverse events, ECG results, vital sign assessments, and review of laboratory tests.
- Quality of Life [ Time Frame: 20 Months ]Quality of Life will be measured by reviewing responses on questionaaires about how the subject is feeling.
- Overall response rate based on RECIST criteria [ Time Frame: 20 Months ]Overall response rate will be measured by the investigator's assessment of how the subject is responding to the study treatment in regards to the RECISIT criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507545
Show 67 Study Locations
|Study Director:||John Heyburn||Morphotek|