Colon CancerPhase 2NCT00675012
NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing NGR-hTNF, Oxaliplatin and capecitabine in people with Colon Cancer, run by AGC Biologics S.p.A. at 1 site in Italy.
Trial summary
The main objective of the trial is to document the safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- NGR-hTNF, Oxaliplatin and capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2007to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years with metastatic colorectal cancer (CRC) treated with no more than three standard systemic regimens (including biologic agents) for metastatic disease
- Life expectancy more than 3 months
- ECOG Performance status 0-1
- 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
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- AST and/or ALT <2.5 x ULN in absence of liver metastasis
- AST and/or ALT <5 x ULN in presence of liver metastasis
- Serum creatinine <1.5 x ULN
- Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min
- Patients may have had prior therapy providing the following conditions are met:
- Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days before start treatment
- Surgery: wash-out period of 14 days before start treatment
- Patients must give written informed consent to participate in the study
Who cannot join
- Concurrent anticancer therapy
- Patients must not receive any other investigational agents while on study
- Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension
- Prolonged QTc interval (congenital or acquired)
- Patient with significant peripheral vascular disease
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- 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
- Symptomatic peripheral neuropathy ≥ grade 1 according the NCI CTCAE v.3.0.
- Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
- Known hypersensitivity/allergic reaction or contraindications to platinum compounds or fluoropyrimidines
- 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
1 site in 1 country.
About this study
Official title: NGR005: Pilot Study of NGR-hTNF Administered at Low and High Doses in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer
The main objective of the trial is to document the safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments
Read the detailed description
Phase II, open-label, non-randomized study that will be conducted in two sequential cohorts of patients. Patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments are planned to be enrolled.
- Conditions
- Colon Cancer
- Being tested
- NGR-hTNF, Oxaliplatin, capecitabine
- Keywords
- NGR-hTNF, Capecitabine, Oxaliplatin, Colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGR-hTNFDrug
iv 0.8 or 45 mcg/sqm q3W
OxaliplatinDrug
iv q3W 100 mg/sqm 60 minutes after NGR-hTNF infusion
capecitabineDrug
orally 825 mg/sqm 2qDx14
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: NGR-hTNF; Drug: Oxaliplatin; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility and safety of NGRhTNF administered at low (0.8 mcg/sqm) and high (45 mcg/sqm) doses in combination with a standard oxaliplatin-based regimen in two sequential cohorts of patients with metastatic colorectal cancer.
Measured: during the study
Secondary outcomes (2)
Document the preliminary antitumor activity in terms of objective response rate (according to RECIST criteria) and progression-free survival
Measured: during the study
Evaluate the pharmacokinetic profile of NGRhTNF and to measure plasma levels of sTNF-RI and sTNF-RII
Measured: before 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 posted8 May 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2010
- Study completionMay 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 Colon CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGC Biologics S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Sobrero, MD, Principal investigator, Azienda Ospedaliera Universitaria San Martino Genoa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675012
- Sponsor's protocol ID
- NGR005
- Other IDs
- 2007-003668-24
- Status last verified
- May 2014
- First submitted
- 5 May 2008
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mammoliti S, Andretta V, Bennicelli E, Caprioni F, Comandini D, Fornarini G, Guglielmi A, Pessino A, Sciallero S, Sobrero AF, Mazzola G, Lambiase A, Bordignon C. Two doses of NGR-hTNF in combination with capecitabine plus oxaliplatin in colorectal cancer patients failing standard therapies. Ann Oncol. 2011 Apr;22(4):973-978. doi: 10.1093/annonc/mdq436. Epub 2010 Sep 20.
PubMed 20855468
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NGR005: Pilot Study of NGR-hTNF Administered at Low and High Doses in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00675012
- Acronym / sponsor ID
- NGR005
- Conditions
- Colon Cancer
- Keywords
- NGR-hTNF, Capecitabine, Oxaliplatin, Colon cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AGC Biologics S.p.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 May 2008 (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 safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments
Detailed description
Phase II, open-label, non-randomized study that will be conducted in two sequential cohorts of patients. Patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments are planned to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NGR-hTNF, Drug: Oxaliplatin, Drug: capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients ≥ 18 years with metastatic colorectal cancer (CRC) treated with no more than three standard systemic regimens (including biologic agents) for metastatic disease
- Life expectancy more than 3 months
- ECOG Performance status 0-1
- Adequate baseline bone marrow, hepatic and renal function, defined as follows:
- Patients may have had prior therapy providing the following conditions are met:
Key exclusion criteria (15 listed)
- Concurrent anticancer therapy
- Patients must not receive any other investigational agents while on study
- Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension
- Prolonged QTc interval (congenital or acquired)
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 0.8 or 45 mcg/sqm q3W | Drug | A |
| Oxaliplatiniv q3W 100 mg/sqm 60 minutes after NGR-hTNF infusion | Drug | A |
| capecitabineorally 825 mg/sqm 2qDx14 | Drug | A |
Primary outcome
To determine the feasibility and safety of NGRhTNF administered at low (0.8 mcg/sqm) and high (45 mcg/sqm) doses in combination with a standard oxaliplatin-based regimen in two sequential cohorts of patients with metastatic colorectal cancer.
Time frame: during the study
2 secondary outcomes
Document the preliminary antitumor activity in terms of objective response rate (according to RECIST criteria) and progression-free survival
Time frame: during the study
Evaluate the pharmacokinetic profile of NGRhTNF and to measure plasma levels of sTNF-RI and sTNF-RII
Time frame: before 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 30 May 2014.
- Results publication: PubMed 20855468Mammoliti S, Andretta V, Bennicelli E, Caprioni F, Comandini D, Fornarini G, Guglielmi A, Pessino A, Sciallero S, Sobrero AF, Mazzola G, Lambiase A, Bordignon C. Two doses of NGR-hTNF in combination with capecitabine plus oxaliplatin in colorectal cancer patients failing standard therapies. Ann Oncol. 2011 Apr;22(4):973-978. doi: 10.1093/annonc/mdq436. Epub 2010 Sep 20.
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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.
Alberto Sobrero, MD principal investigator
Azienda Ospedaliera Universitaria San Martino Genoa, Italy
1 site 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, Oxaliplatin and capecitabine in people with Colon Cancer, run by AGC Biologics S.p.A. at 1 site 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 14 inclusion and 15 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 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine the feasibility and safety of NGRhTNF administered at low (0.8 mcg/sqm) and high (45 mcg/sqm) doses in combination with a standard oxaliplatin-based regimen in two sequential cohorts of patients with metastatic colorectal cancer. (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 NCT00675012, 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 30 May 2014.