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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT00483080
First received: June 5, 2007
Last updated: January 28, 2013
Last verified: January 2013

June 5, 2007
January 28, 2013
December 2006
June 2009   (final data collection date for primary outcome measure)
Antitumour activity defined as Progression Free Survival (PFS) [ Time Frame: during the study ] [ Designated as safety issue: No ]
Antitumour activity defined as Progression Free Survival (PFS)
Complete list of historical versions of study NCT00483080 on ClinicalTrials.gov Archive Site
  • Tumor Growth Control Rate (TGCR) according to RECIST criteria [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Circulating tumor cells (CTCs) [ Time Frame: before and following the treatment ] [ Designated as safety issue: No ]
  • Experimental imaging study (DCE-MRI) [ Time Frame: before and following the first cycle ] [ Designated as safety issue: No ]
  • Pharmacokinetic in patients treated with weekly schedule [ Time Frame: before, during and following the treatment ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: during and following the treatment ] [ Designated as safety issue: Yes ]
Tumor Growth Control Rate (TGCR) according to RECIST criteria Overall survival (OS) Circulating tumor cells (CTCs) and circulating endothelial cells (CECs) Experimental imaging study (DCE-MRI) Adaptative immune response Safety
Not Provided
Not Provided
 
Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC)
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer (CRC)
Drug: NGR-hTNF
iv q3W or q1W NGR-hTNF 0.8 μg/m²
Experimental: A
Intervention: Drug: NGR-hTNF
Santoro A, Rimassa L, Sobrero AF, Citterio G, Sclafani F, Carnaghi C, Pessino A, Caprioni F, Andretta V, Tronconi MC, Finocchiaro G, Rossoni G, Zanoni A, Miggiano C, Rizzardi GP, Traversari C, Caligaris-Cappio F, Lambiase A, Bordignon C. Phase II study of NGR-hTNF, a selective vascular targeting agent, in patients with metastatic colorectal cancer after failure of standard therapy. Eur J Cancer. 2010 Oct;46(15):2746-52. Epub 2010 Aug 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
46
June 2013
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00483080
NGR006, 2006-005451-15
No
MolMed S.p.A.
MolMed S.p.A.
Not Provided
Principal Investigator: Federico Caligaris Cappio, MD Fondazione San Raffaele del Monte Tabor
MolMed S.p.A.
January 2013

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