Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01605318|
Recruitment Status : Withdrawn (No patients are enrolled in any studies conducted under this IND)
First Posted : May 24, 2012
Last Update Posted : August 19, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer Colon Cancer Rectal Cancer||Drug: IMMU-130||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||September 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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.
- Evaluate the safety and tolerability of IMMU-130 [ Time Frame: Every 3 months ]
- Obtain information on efficacy [ Time Frame: During treatment and the changes at 4, 8 and 12 weeks after treatment ]Efficacy will be evaluated from CT scans using RECIST criteria
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605318
|United States, California|
|UCLA Jonsson Comprehensive Cancer Center|
|Santa Monica, California, United States, 90404|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|United States, Delaware|
|Helen F. Graham Cancer Center-Christiana Care|
|Newark, Delaware, United States, 19713|
|United States, Indiana|
|IUHealth Goshen Center for Cancer Care|
|Goshen, Indiana, United States, 46526|
|United States, Ohio|
|The Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43202|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37212|
|Study Chair:||William Wegener||Gilead Sciences|
|Responsible Party:||Gilead Sciences|
|Other Study ID Numbers:||
|First Posted:||May 24, 2012 Key Record Dates|
|Last Update Posted:||August 19, 2021|
|Last Verified:||May 2020|
metastatic colorectal cancer
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological