A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IMMU 130
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, Colorectal Cancer, Rectal Cancer, previously treated
Eligibility Criteria
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, but with no single lesion measuring more than 10.0 cm
- At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities
- Adequate hematology without ongoing transfusional support (hemoglobin > 8 g/dL, ANC ≥ 1,500 per mm3, platelets > 100,000 per mm3)
- Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin within normal limits, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases)
- Otherwise, all acute toxicity at study entry ≤ Grade 1 by NCI CTC v4.0, or recovered to baseline
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. However, patients with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided that they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new enlarging CNS metastasis, (2) off steroids or on a stable dose of steroids.
- Patients with CEA plasma levels > 1000 ng/mL must be approved in advance by the Sponsor.
- Patients with active ≥ Grade 3 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, or are deemed at low risk for recurrence by his/her treating physician.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMMU 130
Arm Description
Outcomes
Primary Outcome Measures
Safety
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.
Secondary Outcome Measures
Assess PK
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01915472
Brief Title
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
Official Title
A Phase II Study of IMMU 130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
September 2013 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase II trial to study the safety and efficacy of IMMU-130. IMMU-130 is composed of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is a common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the immune system. They bind to substances that don't belong in the body to prevent harm to the body. The antibody in this study was designed to bind to a marker located on colorectal cancer tumors. The antibody was originally made from mouse proteins, but was changed in the laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is safe and effective.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic Colorectal Cancer, Colorectal Cancer, Rectal Cancer, previously treated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMMU 130
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IMMU 130
Other Intervention Name(s)
hMN14-SN38, Labetuzumab-SN38, antibody-drug conjugate
Intervention Description
This is a Phase II, open-label study of IMMU-130 administered every 14 days for a period of 24 weeks to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen.
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
Safety will be measured routinely during the 6 months of administration and afterwards during follow-up for up to 5 years
Secondary Outcome Measure Information:
Title
Assess PK
Description
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.
Time Frame
Efficacy will be measured every 8 weeks during treatment and every 3 months during the 1st year and then every 6 months up to 5 years thereafter.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, but with no single lesion measuring more than 10.0 cm
At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities
Adequate hematology without ongoing transfusional support (hemoglobin > 8 g/dL, ANC ≥ 1,500 per mm3, platelets > 100,000 per mm3)
Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin within normal limits, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases)
Otherwise, all acute toxicity at study entry ≤ Grade 1 by NCI CTC v4.0, or recovered to baseline
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. However, patients with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided that they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new enlarging CNS metastasis, (2) off steroids or on a stable dose of steroids.
Patients with CEA plasma levels > 1000 ng/mL must be approved in advance by the Sponsor.
Patients with active ≥ Grade 3 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, or are deemed at low risk for recurrence by his/her treating physician.
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.
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
We'll reach out to this number within 24 hrs