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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Immunomedics, Inc.
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT01605318
First received: May 22, 2012
Last updated: January 22, 2014
Last verified: January 2014

May 22, 2012
January 22, 2014
September 2012
September 2014   (final data collection date for primary outcome measure)
Safety [ Time Frame: Safety during treatment and every 3 months after treatment ] [ Designated as safety issue: Yes ]
Safety and tolerability will be evaluated from adverse events, standard safety laboratories (CBC with differential and platelet count, serum chemistries, urinalysis), physical examination, vital signs, and EKG. Adverse events will be classified according to the MedDRA system of preferred terms and system organ class, and all adverse events and abnormal laboratories will be classified for severity using NCI CTCAE v4.0 toxicity grades. Descriptive statistics will be used to characterize adverse events, cytopenias, and other abnormal laboratories.
Safety [ Time Frame: The change safety at 8 and 12 weeks during treatment and every 3 months after treatment ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01605318 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: measured every 8 weeks during treatement & every 3 months after treatment ] [ Designated as safety issue: No ]
CT (chest, abdomen, pelvis; other if needed) and serum CEA are done every 8 weeks after first dose until the end of treatment or progression of disease and then every 3 months during follow up. CT may be obtained more frequently at the physician discretion to assess disease status.for up to 2 years or until progression of disease.
Efficacy [ Time Frame: measured at 8 & 12 weeks during treatment, then every 3 months after treatment ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer.

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
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
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
104
December 2015
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Pius Maliakal, PhD 973-605-8200 pmaliakal@immunomedics.com
Contact: Roman Gomez, CCRP 973-605-8200 rgomez@immunomedics.com
United States
 
NCT01605318
IM-T-IMMU-130-02
No
Immunomedics, Inc.
Immunomedics, Inc.
Not Provided
Not Provided
Immunomedics, Inc.
January 2014

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