Advanced Solid TumorsPhase 1NCT00419328
A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors
A Phase 1 study testing NGR-hTNF in people with Advanced Solid Tumors, run by AGC Biologics S.p.A. at 1 site in Italy.
Trial summary
The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- 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
- 16 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2005to Sep 2007
- Phase
- Phase 1
- 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 old with proven advanced solid tumors not amenable to any clinical improvement by current standard treatments. Tumors recognized to be highly vascularized (e.g. renal, colon thyroid and head and neck cancers), will be included.
- ECOG Performance status 0 - 2
- Patients may have had prior therapy providing the following conditions are met:
- Chemo, radio, hormonal or immunotherapy: wash-out period of 28 days
- Surgery: wash-out period of 14 days
- Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Show all 14Show fewer
- 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 haemodilution 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
- 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
1 site in 1 country.
About this study
Official title: NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose
The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media.
Read the detailed description
This is a modified phase I Single arm, open, non randomized trial of NGR-hTNF in advanced solid tumors for the definition of an optimal biological
- Conditions
- Advanced Solid Tumors
- Being tested
- NGR-hTNF
- Keywords
- solid tumors NGR-hTNF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGR-hTNFDrug
Also called iv q3W escalating dose up 1.6 mcg/sqm
Drug: NGR-hTNF
NGR-hTNF was administered every 3 weeks by a 1 hour intravenous iv infusion. NGR-hTNF in PBS was diluted in 0.9% NaCl, containing human serum albumin.
Step 1:
- starting dose: 0.2 μg/m2
- following doses: 0.4, 0.8 and 1.6 μg/m2.
- number of patients: 4 per dose level
Step 2:
- starting dose: 3.2 μg/m2
- following doses: 6.4 and 12.8 μg/m2
- number of patients: 3 per dose level
Step 3:
- starting dose: 19.2 μg/m2
- following doses: 28.8, 43.2 and 64.8 μg/m2
- number of patients: 3 per dose level
Step 4:
- starting dose: 86.2 μg/m2
- following doses: 114.6 and 152.4 μg/m2
- number of patients: 3 per dose level
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm A | Experimental | Patients were scheduled to receive a 1 hour intravenous (iv) infusion of NGR-hTNF every 3weeks.- The dose of administered NGR-hTNF was: 0.2, 0.4, 0.8, 1.6 μg/m2 (step 1); 3.2, 6.4, 12.8 μg/m2 (step 2); 19.2, 28.8, 43.2 64.8 μg/m2 (step 3); 86.2, 114.6, 152.4 μg/m2 (step 4) Receives: Drug: NGR-hTNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify safety of escalating doses of NGR-hTNF
To verify safety of escalating doses of NGR-hTNF
Measured: during and following the treatment
Secondary outcomes (2)
To document possible modifications on vessels permeability
To document possible modifications on vessels permeability
Measured: before and following the first treatment
To document signs of anticancer activity
To document signs of anticancer activity
Measured: every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startMar 2005
- Primary completionSep 2007
- Study completionSep 2007
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 Advanced Solid TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGC Biologics S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Lambiase, MD, Study director, AGC Biologics S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419328
- Sponsor's protocol ID
- NGR002
- Other IDs
- 2004-002194-23, 2004
- Status last verified
- Jan 2013
- First submitted
- 5 Jan 2007
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Gregorc V, Citterio G, Vitali G, Spreafico A, Scifo P, Borri A, Donadoni G, Rossoni G, Corti A, Caligaris-Cappio F, Del Maschio A, Esposito A, De Cobelli F, Dell'Acqua F, Troysi A, Bruzzi P, Lambiase A, Bordignon C. Defining the optimal biological dose of NGR-hTNF, a selective vascular targeting agent, in advanced solid tumours. Eur J Cancer. 2010 Jan;46(1):198-206. doi: 10.1016/j.ejca.2009.10.005.
PubMed 19900802
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose
- ClinicalTrials.gov ID
- NCT00419328
- Acronym / sponsor ID
- NGR002
- Conditions
- Advanced Solid Tumors
- Keywords
- solid tumors NGR-hTNF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AGC Biologics S.p.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 8 Jan 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 explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media.
Detailed description
This is a modified phase I Single arm, open, non randomized trial of NGR-hTNF in advanced solid tumors for the definition of an optimal biological
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm A | Experimental | Drug: NGR-hTNFPatients were scheduled to receive a 1 hour intravenous (iv) infusion of NGR-hTNF every 3weeks.- The dose of administered NGR-hTNF was: 0.2, 0.4, 0.8, 1.6 μg/m2 (step 1); 3.2, 6.4, 12.8 μg/m2 (step 2); 19.2, 28.8, 43.2 64.8 μg/m2 (step 3); 86.2, 114.6, 152.4 μg/m2 (step 4) |
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 old with proven advanced solid tumors not amenable to any clinical improvement by current standard treatments. Tumors recognized to be highly vascularized (e.g. renal, colon thyroid and head and neck cancers), will be included.
- ECOG Performance status 0 - 2
- Patients may have had prior therapy providing the following conditions are met:
- 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
Key exclusion criteria (7 listed)
- 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
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-hTNFAlso: iv q3W escalating dose up 1.6 mcg/sqmDrug: NGR-hTNF NGR-hTNF was administered every 3 weeks by a 1 hour intravenous iv infusion. NGR-hTNF in PBS was diluted in 0.9% NaCl, containing human serum albumin. Step 1: * starting dose: 0.2 μg/m2 * following doses: 0.4, 0.8 and 1.6 μg/m2. * number of patients: 4 per dose level Step 2: * starting dose: 3.2 μg/m2 * following doses: 6.4 and 12.8 μg/m2 * number of patients: 3 per dose level Step 3: * starting dose: 19.2 μg/m2 * following doses: 28.8, 43.2 and 64.8 μg/m2 * number of patients: 3 per dose level Step 4: * starting dose: 86.2 μg/m2 * following doses: 114.6 and 152.4 μg/m2 * number of patients: 3 per dose level | Drug | Experimental Arm A |
Primary outcome
To verify safety of escalating doses of NGR-hTNF
Time frame: during and following the treatment
To verify safety of escalating doses of NGR-hTNF
2 secondary outcomes
To document possible modifications on vessels permeability
Time frame: before and following the first treatment
To document signs of anticancer activity
Time frame: every 6 weeks
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 21 Jul 2022.
- Results publication: PubMed 19900802Gregorc V, Citterio G, Vitali G, Spreafico A, Scifo P, Borri A, Donadoni G, Rossoni G, Corti A, Caligaris-Cappio F, Del Maschio A, Esposito A, De Cobelli F, Dell'Acqua F, Troysi A, Bruzzi P, Lambiase A, Bordignon C. Defining the optimal biological dose of NGR-hTNF, a selective vascular targeting agent, in advanced solid tumours. Eur J Cancer. 2010 Jan;46(1):198-206. doi: 10.1016/j.ejca.2009.10.005.
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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.
Antonio Lambiase, MD study director
AGC Biologics S.p.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NGR-hTNF in people with Advanced Solid Tumors, 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 7 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 21 Jul 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 verify safety of escalating doses of NGR-hTNF (time frame: during and following the treatment). 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 NCT00419328, 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 21 Jul 2022.