Study of IMMU-130 in Patients With Relapsed/Refractory Colorectal Cancer
|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: NCT01270698|
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : January 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: IMMU-130||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of IMMU-130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Colorectal Cancer.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
IMMU-130 will be administered intravenously every 2 weeks for up to 6 months or longer.
Other Name: hMN14-SN38
- Safety [ Time Frame: Safety will be measured routinely during the 6 months of administration and afterwards during follow-up for up to 5 years ]The primary outcome measured will be safety of IMMU-130 administered at different dose levels. Safety will be assessed by reviewing the number of adverse events and overall toxicity.
- efficacy [ Time Frame: Efficacy will be measured every 8-12 weeks during treatment and every 6 months during the 2nd year and then annually up to 5 years thereafter. ]The secondary objectives are to assess pharmacokinetics and immunogenicity, and to obtain preliminary information on efficacy with this dosing schedule. Efficacy will be assessed using CT scan imaging.
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): NCT01270698
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|