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
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Cancer
Colon Cancer
Rectal Cancer
Drug: IMMU-130
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 104
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605318

Contacts
Contact: Pius Maliakal, PhD 973-605-8200 pmaliakal@immunomedics.com
Contact: Roman Gomez, CCRP 973-605-8200 rgomez@immunomedics.com

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Jamie Bendrick-Peart    720-848-0600    JAMIE.BENDRICK-PEART@UCDENVER.EDU   
Principal Investigator: Christopher\ Lieu, MD         
United States, Delaware
Helen F. Graham Cancer Center-Christiana Care Recruiting
Newark, Delaware, United States, 19713
Contact: Kathy Combs, RN, OCN       kcombs@christianacare.org   
Principal Investigator: Michael Guarino, MD         
United States, Indiana
IUHealth Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
Contact: Tracy Thorne, RN    574-364-2439    tthorne@iuhealth.org   
Principal Investigator: Alexander Starodub, MD         
United States, Pennsylvania
Fox Chase Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Alexis Dickens       Alexis.Dickens@fccc.edu   
Principal Investigator: Efrat Dotan, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Wendy VerMeulen, RN    800-811-8480    wendy.vermeulen@vanderbilt.edu   
Principal Investigator: Jordan Berlin, MD         
Sponsors and Collaborators
Immunomedics, Inc.
  More Information

Publications:
Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT01605318     History of Changes
Other Study ID Numbers: IM-T-IMMU-130-02
Study First Received: May 22, 2012
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:
metastatic colorectal cancer
colon cancer
rectal cancer
previously treated

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies
Irinotecan
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014