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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Recruitment Status : Withdrawn (No patients are enrolled in any studies conducted under this IND)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 : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Tracking Information
First Submitted Date  ICMJE May 22, 2012
First Posted Date  ICMJE May 24, 2012
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2020)
Evaluate the safety and tolerability of IMMU-130 [ Time Frame: Every 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
Safety [ Time Frame: The change safety at 8 and 12 weeks during treatment and every 3 months after treatment ]
Safety will be assessed by measuring the changes in safety labs or physical exam changes at 8 and 12 weeks during treatment and then every 3 months after treatment for up to 2 years.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2020)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
Efficacy [ Time Frame: measured at 8 & 12 weeks during treatment, then every 3 months after treatment ]
Efficacy will be measured by comparing the CT results from baseline to those done at 8 and 12 weeks during treatment and then every 3 months for up to 2 years or until progression of disease.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
Official Title  ICMJE A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: IMMU-130
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 8, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2012)
24
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01605318
Other Study ID Numbers  ICMJE IM-T-IMMU-130-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immunomedics, Inc.
Study Sponsor  ICMJE Immunomedics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: William Wegener Immunomedics, Inc.
PRS Account Immunomedics, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP