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

NCT00483080 | Completed Phase 2

• 2 other identifiers: NGR0062006-005451-15
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Cancer (CRC)

Keywords

NGR-hTNF; CRC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)

  during the study

Secondary Outcomes (7)

• Tumor Growth Control Rate (TGCR)

  during the study

• Overall survival (OS)

  during the study

• Circulating tumor cells (CTCs)

  before and following the treatment

• Experimental imaging study (DCE-MRI)

  before and following the first cycle

• to evaluate AUC(tau) of NGR-hTNF in patients treated with weekly schedule

  during the first 6 weeks (time points: prior to infusion, 20 minutes, 60 minutes, 90 minutes, 120 minutes and 240 minutes after treatment start)

Study Arms (1)

A: NGR-hTNF

EXPERIMENTAL

NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every 3 weeks or weekly

Drug: NGR-hTNF

Interventions

NGR-hTNF DRUG

iv q3W or q1W NGR-hTNF 0.8 μg/m²

A: NGR-hTNF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AGC Biologics S.p.A.: lead

Study Sites (3)

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Location

Azienda Ospedaliera Universitaria "San Martino"

Genoa, Italy

Location

Fondazione San Raffaele del Monte Tabor

Milan, Italy

Location

Related Publications (1)

• 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. doi: 10.1016/j.ejca.2010.07.012. Epub 2010 Aug 12.

  PMID: 20708923 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tumor necrosis factor-alpha, CNGRC fusion protein, human

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Federico Caligaris Cappio, MD

  Fondazione San Raffaele del Monte Tabor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 6, 2007
• Study Start: December 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: April 1, 2013
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

IT (3)