Study of the Safety of VB6-845 in Patients With Advanced Solid Tumours of Epithelial Origin

This study has been terminated.
(Corporate reasons unrelated to safety and efficacy)
Sponsor:
Information provided by:
Viventia Biotech
ClinicalTrials.gov Identifier:
NCT00481936
First received: May 31, 2007
Last updated: September 8, 2008
Last verified: September 2008
  Purpose

The purpose of this study is to determine the maximum tolerated dose (MTD) of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion to patients with advanced solid tumour of epithelial origin.


Condition Intervention Phase
Neoplasms, Glandular and Epithelial
Drug: VB6-845
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Phase I, Escalating Dose Study of VB6-845, a Recombinant Fusion Protein Targeting EpCAM, in Patients With Advanced Solid Tumours of Epithelial Origin

Resource links provided by NLM:


Further study details as provided by Viventia Biotech:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics, immunogenicity and exploratory efficacy of VB6-845 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: May 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: VB6-845
    Intravenous infusion once weekly for 4 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Disease Characteristics:

  • The patient must have locally advanced and/or metastatic solid tumour of epithelial origin for which standard therapy has failed or does not exist;
  • The patient must have immunohistochemically-confirmed EpCAM positive disease;

Patient Characteristics:

  • The patient must be male or female 18 years of age or older;
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and life expectancy ≥ 12 weeks
  • The patient must have adequate organ function, as defined by the protocol
  • Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the first dose of the study drug;

Other:

  • The patient must be able to understand and willing to sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
  • The patient must be willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • The patient has had treatment with any investigational agent within 4 weeks, or treatment with radiation therapy to a visceral organ, immunotherapy, biological therapy, or chemotherapy within 2 weeks prior to the first dose of study medication
  • The patient has not adequately recovered from the toxic effects of previous therapy, except treatment-related anemia otherwise meeting the inclusion requirements stated above in inclusion number 5 or alopecia;
  • The patient has known clinically significant brain metastases or leptomeningeal disease (baseline computed tomography [CT] or magnetic resonance imaging [MRI] of the brain is only required if there is clinical suspicion of central nervous system involvement);
  • The patient has experienced a previous significant hypersensitivity reaction;
  • The patient has known acquired immune deficiency disease or has active hepatitis virus C (HVC) or active hepatitis virus B (HVB);
  • The patient is pregnant or breast feeding; female patients will be required to be surgically sterile, agree to use double barrier contraception, or commit to abstinence during the period of therapy; male patients will be required to be surgically sterile, use double barrier contraception, or commit to abstinence during the period of therapy
  • The patient has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
  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: NCT00481936

Locations
Georgia
Chemotherapy and Immunotherapy clinic Medulla
Tbilisi, Georgia
Russian Federation
Blokhin Cancer Research Centre, Department of Clinical Pharmacology and Chemotherapy
Moscow, Russian Federation
Blokhin Cancer Research Centre, Department of Chemotherapy and Combined therapy
Moscow, Russian Federation
Moscow City Oncology Hospital #62
Moscow, Russian Federation
Non state Institution of Ministry of Health "Central Clinical Hospital #2 named after N.A. Semashko" of Open-joint stock company "Russian Railways"
Moscow, Russian Federation
Yaroslavi Regional Clinical Oncology Hospital
Yaroslav, Russian Federation
Sponsors and Collaborators
Viventia Biotech
Investigators
Study Director: Wendy Cuthbert Viventia Biotech
  More Information

No publications provided

Responsible Party: Wendy Cuthbert, Vice President, Clinical Development, Viventia Biotech Inc
ClinicalTrials.gov Identifier: NCT00481936     History of Changes
Other Study ID Numbers: VB6-845-01-I
Study First Received: May 31, 2007
Last Updated: September 8, 2008
Health Authority: Georgia: Ministry of Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by Viventia Biotech:
Neoplasms
Neoplasm, Epithelial
Neoplasm, Glandular

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 19, 2014