Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC)

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. Identifier: NCT00483080
Recruitment Status : Completed
First Posted : June 6, 2007
Last Update Posted : May 30, 2014
Information provided by (Responsible Party):
MolMed S.p.A.

Brief Summary:
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic colorectal cancer patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.

Condition or disease Intervention/treatment Phase
Colorectal Cancer (CRC) Drug: NGR-hTNF Phase 2

Detailed Description:
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, that will be conducted using Simon's two-stage design method.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NGR006: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Colorectal Cancer (CRC), Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan Based Regimens
Study Start Date : December 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: NGR-hTNF
iv q3W or q1W NGR-hTNF 0.8 μg/m²

Primary Outcome Measures :
  1. Antitumour activity defined as Progression Free Survival (PFS) [ Time Frame: during the study ]

Secondary Outcome Measures :
  1. Tumor Growth Control Rate (TGCR) according to RECIST criteria [ Time Frame: during the study ]
  2. Overall survival (OS) [ Time Frame: during the study ]
  3. Circulating tumor cells (CTCs) [ Time Frame: before and following the treatment ]
  4. Experimental imaging study (DCE-MRI) [ Time Frame: before and following the first cycle ]
  5. Pharmacokinetic in patients treated with weekly schedule [ Time Frame: before, during and following the treatment ]
  6. Safety [ Time Frame: during and following the treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients >18 years affected by advanced or metastatic colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, but not more than three lines of therapy. Adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy

    • ECOG Performance status 0 - 1
    • Patients in progression disease at study entry, CT documented
    • Adequate baseline bone marrow, hepatic and renal function, defined as follows:
  • Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
  • Bilirubin < 1.5 x ULN
  • AST and/or ALT < 2.5 x ULN in absence of liver metastases
  • AST and/or ALT < 5 x ULN in presence of liver metastases
  • Serum creatinine < 1.5 x ULN

    • Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or hemodilution could represent a risk for the patient (reference appendix "Technical data sheet human albumin")
    • Normal cardiac function and absence of uncontrolled hypertension
    • Patients must give written informed consent to participate in the study

Exclusion Criteria:

  • More than three lines of chemotherapy (except biological agents)
  • Concurrent anticancer therapy
  • Patients may not receive any other investigational agents while on study
  • Clinical signs of CNS involvement
  • Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
  • Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
  • Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e.menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00483080

Istituto Clinico Humanitas
Rozzano, Milan, Italy
Azienda Ospedaliera Universitaria "San Martino"
Genoa, Italy
Fondazione San Raffaele del Monte Tabor
Milan, Italy
Sponsors and Collaborators
MolMed S.p.A.
Principal Investigator: Federico Caligaris Cappio, MD Fondazione San Raffaele del Monte Tabor

Publications of Results:
Responsible Party: MolMed S.p.A. Identifier: NCT00483080     History of Changes
Other Study ID Numbers: NGR006
2006-005451-15 ( EudraCT Number )
First Posted: June 6, 2007    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by MolMed S.p.A.:

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases