Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles, once or 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 these dosing schedules and to obtain preliminary information on its efficacy.
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/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer.|
- Safety [ Time Frame: Safety during treatment and every 3 months after treatment ] [ Designated as safety issue: Yes ]Safety and tolerability will be evaluated from adverse events, standard safety laboratories (CBC with differential and platelet count, serum chemistries, urinalysis), physical examination, vital signs, and EKG. Adverse events will be classified according to the MedDRA system of preferred terms and system organ class, and all adverse events and abnormal laboratories will be classified for severity using NCI CTCAE v4.0 toxicity grades. Descriptive statistics will be used to characterize adverse events, cytopenias, and other abnormal laboratories.
- Efficacy [ Time Frame: measured every 8 weeks during treatement & every 3 months after treatment ] [ Designated as safety issue: No ]CT (chest, abdomen, pelvis; other if needed) and serum CEA are done every 8 weeks after first dose until the end of treatment or progression of disease and then every 3 months during follow up. CT may be obtained more frequently at the physician discretion to assess disease status.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)|
All patients receive IMMU-130 administered in 21-day treatment cycles consisting of once or twice weekly for 2 consecutive weeks followed by a 1-week rest period. Treatment can be continued in the absence of unacceptable toxicity for a period of up to 8 cycles until the first documentation of Progressive Disease by CT (physician discretion), but must terminate study treatment upon the second documentation of Progressive Disease.
This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles, once or 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.
|Contact: Pius Maliakal, PhDemail@example.com|
|Contact: Roman Gomez, CCRPfirstname.lastname@example.org|
|United States, Delaware|
|Helen F. Graham Cancer Center-Christiana Care||Recruiting|
|Newark, Delaware, United States, 19713|
|Contact: Kathy Combs, RN, OCN email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Alexander Starodub, MD|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19111|
|Contact: Alexis Dickens Alexis.Dickens@fccc.edu|
|Principal Investigator: Efrat Dotan, MD|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Contact: Wendy VerMeulen, RN 800-811-8480 email@example.com|
|Principal Investigator: Jordan Berlin, MD|