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

NCT ID: NCT00483080

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2013-04-30

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.

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.

Conditions

Colorectal Cancer (CRC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: NGR-hTNF

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

Group Type: EXPERIMENTAL

NGR-hTNF

Intervention Type: DRUG

iv q3W or q1W NGR-hTNF 0.8 μg/m²

Interventions

NGR-hTNF

iv q3W or q1W NGR-hTNF 0.8 μg/m²

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AGC Biologics S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Federico Caligaris Cappio, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione San Raffaele del Monte Tabor

Locations

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Azienda Ospedaliera Universitaria "San Martino"

Genoa, , Italy

Fondazione San Raffaele del Monte Tabor

Milan, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 20708923 (View on PubMed)

Other Identifiers

2006-005451-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NGR006

Identifier Type: -

Identifier Source: org_study_id