Back to results

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

Primary Purpose

Colorectal Cancer (CRC)

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

NGR-hTNF

About this trial

This is an interventional treatment trial for Colorectal Cancer (CRC) focused on measuring NGR-hTNF, CRC

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istituto Clinico Humanitas
Azienda Ospedaliera Universitaria "San Martino"
Fondazione San Raffaele del Monte Tabor

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A: NGR-hTNF

Arm Description

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

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

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

Secondary Outcome Measures

Tumor Growth Control Rate (TGCR)

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

Overall survival (OS)

Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive

Circulating tumor cells (CTCs)

To document modification of CTCs

Experimental imaging study (DCE-MRI)

to document possible modifications on vessels permeability

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

to evaluate AUC(tau) of NGR-hTNF administered weekly

to evaluate Cmax of NGR-hTNF in patients treated with weekly schedule

to evaluate Cmax of NGR-hTNF administered weekly

Safety according to NCI-CTCAE criteria (version 3)

To evaluate safety profile related to NGR-hTNF

Full Information

NCT ID

NCT00483080

First Posted

June 5, 2007

Last Updated

January 14, 2019

Sponsor

AGC Biologics S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT00483080

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AGC Biologics S.p.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer (CRC)

Keywords

NGR-hTNF, CRC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: NGR-hTNF

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

NGR-hTNF

Intervention Description

iv q3W or q1W NGR-hTNF 0.8 μg/m²

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

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

Time Frame

during the study

Secondary Outcome Measure Information:

Title

Tumor Growth Control Rate (TGCR)

Description

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

Time Frame

during the study

Title

Overall survival (OS)

Description

Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive

Time Frame

during the study

Title

Circulating tumor cells (CTCs)

Description

To document modification of CTCs

Time Frame

before and following the treatment

Title

Experimental imaging study (DCE-MRI)

Description

to document possible modifications on vessels permeability

Time Frame

before and following the first cycle

Title

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

Description

to evaluate AUC(tau) of NGR-hTNF administered weekly

Time Frame

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

Title

to evaluate Cmax of NGR-hTNF in patients treated with weekly schedule

Description

to evaluate Cmax of NGR-hTNF administered weekly

Time Frame

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

Title

Safety according to NCI-CTCAE criteria (version 3)

Description

To evaluate safety profile related to NGR-hTNF

Time Frame

during and following the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Federico Caligaris Cappio, MD

Organizational Affiliation

Fondazione San Raffaele del Monte Tabor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Clinico Humanitas

City

Rozzano

State/Province

Milan

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria "San Martino"

City

Genoa

Country

Italy

Facility Name

Fondazione San Raffaele del Monte Tabor

City

Milan

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

20708923

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs