Clinical Trials /

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

NCT01605318

Description:

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.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
  • 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.

Clinical Trial IDs

  • ORG STUDY ID: IM-T-IMMU-130-02
  • NCT ID: NCT01605318

Conditions

  • Metastatic Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer

Interventions

DrugSynonymsArms
IMMU-130hMN14-SN38, Labetuzumab-SN38, Antibody-Drug ConjugateIMMU-130

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.

Trial Arms

NameTypeDescriptionInterventions
IMMU-130ExperimentalAll 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.
  • IMMU-130

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety
Time Frame:Safety during treatment and every 3 months after treatment
Safety Issue:
Description: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

Measure:Efficacy
Time Frame:measured every 8 weeks during treatement & every 3 months after treatment
Safety Issue:
Description: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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Immunomedics, Inc.

Trial Keywords

  • metastatic colorectal cancer
  • colon cancer
  • rectal cancer
  • previously treated

Last Updated

March 18, 2016