Colorectal Cancer (CRC)Phase 2NCT00483080
Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC)
A Phase 2 study testing NGR-hTNF in people with Colorectal Cancer (CRC), run by AGC Biologics S.p.A. at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- NGR-hTNF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesItaly
- Study dates
- Dec 2006to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Azienda Ospedaliera Universitaria "San Martino"
Genoa
Fondazione San Raffaele del Monte Tabor
Milan
Istituto Clinico Humanitas
Rozzano, Milan
About this study
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
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.
Read the 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)
- Being tested
- NGR-hTNF
- Keywords
- NGR-hTNF, CRC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGR-hTNFDrug
iv q3W or q1W NGR-hTNF 0.8 μg/m²
| Study group | Role | What they receive |
|---|---|---|
| A: NGR-hTNF | Experimental | NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every 3 weeks or weekly Receives: Drug: NGR-hTNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
Measured: during the study
Secondary outcomes (7)
Tumor Growth Control Rate (TGCR)
TGCR evaluated according to Response evaluation criteria in solid tumors (RECIST)
Measured: during the study
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
Measured: during the study
Circulating tumor cells (CTCs)
To document modification of CTCs
Measured: before and following the treatment
Experimental imaging study (DCE-MRI)
to document possible modifications on vessels permeability
Measured: before and following the first cycle
to evaluate AUC(tau) of NGR-hTNF in patients treated with weekly schedule
to evaluate AUC(tau) of NGR-hTNF administered weekly
Measured: 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 in patients treated with weekly schedule
to evaluate Cmax of NGR-hTNF administered weekly
Measured: during the first 6 weeks (time points: prior to infusion, 20 minutes, 60 minutes, 90 minutes, 120 minutes and 240 minutes after treatment start)
Safety according to NCI-CTCAE criteria (version 3)
To evaluate safety profile related to NGR-hTNF
Measured: during and following the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2009
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGC Biologics S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Federico Caligaris Cappio, MD, Principal investigator, Fondazione San Raffaele del Monte Tabor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483080
- Sponsor's protocol ID
- NGR006
- Other IDs
- 2006-005451-15
- Status last verified
- Jan 2019
- First submitted
- 5 Jun 2007
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20708923
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00483080
- Acronym / sponsor ID
- NGR006
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- NGR-hTNF, CRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AGC Biologics S.p.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A: NGR-hTNF | Experimental | Drug: NGR-hTNFNGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every 3 weeks or weekly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGR-hTNFiv q3W or q1W NGR-hTNF 0.8 μg/m² | Drug | A: NGR-hTNF |
Primary outcome
Progression Free Survival (PFS)
Time frame: during the study
PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
7 secondary outcomes
Tumor Growth Control Rate (TGCR)
Time frame: during the study
Overall survival (OS)
Time frame: during the study
Circulating tumor cells (CTCs)
Time frame: before and following the treatment
Experimental imaging study (DCE-MRI)
Time frame: before and following the first cycle
to evaluate AUC(tau) of NGR-hTNF in patients treated with weekly schedule
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)
to evaluate Cmax of NGR-hTNF in patients treated with weekly schedule
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)
Safety according to NCI-CTCAE criteria (version 3)
Time frame: during and following the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Results publication: PubMed 20708923Santoro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Caligaris Cappio, MD principal investigator
Fondazione San Raffaele del Monte Tabor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NGR-hTNF in people with Colorectal Cancer (CRC), run by AGC Biologics S.p.A. at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: during the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.