Status:
WITHDRAWN
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Gilead Sciences
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 chemoth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01915472
Start Date
September 1 2013
End Date
August 1 2015
Last Update
August 19 2021
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