Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer

Sponsor

Gilead Sciences (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01605318

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer Colon Cancer Rectal Cancer	Drug: IMMU-130	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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.

Actual Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMMU-130 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.	Drug: IMMU-130 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. Other Names: hMN14-SN38 Labetuzumab-SN38 Antibody-Drug Conjugate

Arm

Intervention/Treatment

Experimental: IMMU-130

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.

Drug: IMMU-130

Other Names:

hMN14-SN38

Labetuzumab-SN38

Antibody-Drug Conjugate

Outcome Measures

Primary Outcome Measures

Evaluate the safety and tolerability of IMMU-130 [Every 3 months]

Secondary Outcome Measures

Obtain information on efficacy [During treatment and the changes at 4, 8 and 12 weeks after treatment]
Efficacy will be evaluated from CT scans using RECIST criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients, ≥ 18 years of age, able to understand and give written informed consent.
Histologically or cytologically confirmed colorectal adenocarcinoma.
Stage IV (metastatic) disease.
Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer.
Adequate performance status (ECOG 0 or 1). (Appendix 1)
Expected survival > 6 months.
CEA plasma levels > 5 ng/mL.
Measurable disease by CT or MRI.
At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities.
At least 2 weeks beyond corticosteroids.
Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
Otherwise, all toxicity at study entry ≤ Grade 1 by NCI CTC v4.0.

Exclusion Criteria:

Women who are pregnant or lactating.
Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
Patients with Gilbert's disease or known CNS metastatic disease.
Patients with CEA plasma levels > 1000 ng/mL are excluded during dose escalation, but may be included after the MTD is determined.
Presence of bulky disease (defined as any single mass > 10 cm in its greatest dimension).
Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
Infection requiring intravenous antibiotic use within 1 week.
Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Jonsson Comprehensive Cancer Center	Santa Monica	California	United States	90404
2	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045
3	Helen F. Graham Cancer Center-Christiana Care	Newark	Delaware	United States	19713
4	IUHealth Goshen Center for Cancer Care	Goshen	Indiana	United States	46526
5	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43202
6	Fox Chase	Philadelphia	Pennsylvania	United States	19111
7	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37212