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

• Sponsor: AGC Biologics S.p.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00483080
• Collaborator: (none)
• Enrollment: 46
• Locations: 3
• Arm: 1
• Duration (Months): 76
• Patients Per Site: 15.3
• Patients Per Site Per Month: 0.2

Study Details

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.

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 Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• 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: Dec 1, 2006
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A: NGR-hTNF NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every 3 weeks or weekly	Drug: NGR-hTNF; iv q3W or q1W NGR-hTNF 0.8 μg/m²

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [during the study]

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

Secondary Outcome Measures

1. Tumor Growth Control Rate (TGCR) [during the study]

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

2. Overall survival (OS) [during the study]

   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

3. Circulating tumor cells (CTCs) [before and following the treatment]

   To document modification of CTCs

4. Experimental imaging study (DCE-MRI) [before and following the first cycle]

   to document possible modifications on vessels permeability

5. 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)]

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

6. to evaluate Cmax 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)]

   to evaluate Cmax of NGR-hTNF administered weekly

7. Safety according to NCI-CTCAE criteria (version 3) [during and following the treatment]

   To evaluate safety profile related to NGR-hTNF

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Clinico Humanitas	Rozzano	Milan	Italy
2	Azienda Ospedaliera Universitaria "San Martino"	Genoa		Italy
3	Fondazione San Raffaele del Monte Tabor	Milan		Italy

Sponsors and Collaborators

• AGC Biologics S.p.A.

Investigators

• Principal Investigator: Federico Caligaris Cappio, MD, Fondazione San Raffaele del Monte Tabor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AGC Biologics S.p.A.
• ClinicalTrials.gov Identifier: NCT00483080
• Other Study ID Numbers: NGR006; 2006-005451-15
• First Posted: Jun 6, 2007
• Last Update Posted: Jan 16, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by AGC Biologics S.p.A.: NGR-hTNF; CRC
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Jan 16, 2019