Dose Finding Study of Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
This is a Phase I, open-label study of IMMU-130 administered in 21-day treatment cycles, twice weekly for 2 consecutive weeks followed by one week of rest to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen. The study is being done to evaluate whether the study drug is safe and tolerable at different dose levels with this dosing schedule.
Metastatic Colorectal Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Twice Weekly IMMU-130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Colorectal Cancer.|
- Safety [ Time Frame: The change safety at 8 and 12 weeks during treatment and every 3 months after treatment ] [ Designated as safety issue: Yes ]Safety will be assessed by measuring the changes in safety labs or physical exam changes at 8 and 12 weeks during treatment and then every 3 months after treatment for up to 2 years.
- Efficacy [ Time Frame: measured at 8 & 12 weeks during treatment, then every 3 months after treatment ] [ Designated as safety issue: No ]Efficacy will be measured by comparing the CT results from baseline to those done at 8 and 12 weeks during treatment and then every 3 months for up to 2 years or until progression of disease.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
This is a Phase I, open-label study of IMMU-130 administered in 21-day treatment cycles, twice weekly for 2 consecutive weeks followed by one week of rest to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen. Up to 4 treatment cycles will be given.
|Contact: Jonathan Rojo, MDfirstname.lastname@example.org|
|Contact: Susan Garl, RNemail@example.com|
|United States, Delaware|
|Helen F. Graham Cancer Center-Christiana Care||Recruiting|
|Newark, Delaware, United States, 19713|
|Contact: Kathy Combs, RN, OCN firstname.lastname@example.org|
|Principal Investigator: Michael Guarino, MD|
|United States, Indiana|
|IUHealth Goshen Center for Cancer Care||Recruiting|
|Goshen, Indiana, United States, 46526|
|Contact: Tracy Thorne, RN 574-364-2439 email@example.com|
|Principal Investigator: Alexander Starodub, MD|
|United States, Pennsylvania|
|Fox Chase||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator: Efrat Dotan, MD|