CancerPhase 1/2NCT01240720
A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer
A Phase 1/2 study testing 131I-F16SIP Radioimmunotherapy (RIT) in people with Cancer, run by Philogen S.p.A. at 6 sites in Italy.
Trial summary
The aim of this Study Protocol is to provide a basis for the clinical development of 131I-F16SIP as an anti-cancer therapeutic agent. The study follows and is greatly motivated by the promising results of a Phase I/II study with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- 131I-F16SIP Radioimmunotherapy (RIT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 6 sitesItaly
- Study dates
- Sep 2008to Apr 2013
- Phase
- Phase 1/2
- 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
- Phase I:
- Patients with cancer, with progressive disease in pre-study period, refractory to conventional standard treatments.
- Solid Tumor: Histologically/cytologically confirmed diagnosis of cancer, preferably lung cancer, prostate cancer or colorectal cancer (CRC). At least one measurable (minimum 2.0 cm), non irradiated lesion defined according to modified RECIST criteria i.e. whenever the measurable disease is restricted to a solitary lesion, its neoplastic nature need not be confirmed by cytology/histology.
- Lymphoproliferative Diseases: Histologically/cytologically confirmed diagnosis of lymphoproliferative disease. At least one measurable (minimum 2.0 cm) non irradiated lesion defined according to modified RECIST criteria, i.e. whenever the measurable disease is restricted to a solitary lesion; its neoplastic nature needs to be confirmed by cytology/histology.
- Phase II:
- Patients with lymphoma, breast cancer or lung cancer with progressive disease in pre-study period, refractory to conventional standard treatments, will be enrolled in the study. Presence of brain metastases at time of screening does not represent an exclusion criterion. Lesions will be evaluated according to RECIST for solid tumors or to the Revised response criteria for malignant lymphoma (Cheson BD, JCO 2007, 25, 579-58) for lymphomas.
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- ECOG performance status grade 0 or 1.
- Age ≥18.
- Adequate haematological, liver and renal function (haemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1.50 x 109/L; platelets ≥ 100 x 109/L, bilirubin within UNL; alkaline phosphatase≤ 2.5 x UNL; ALT, AST ≤ UNL or ≤ 2.5 x UNL in case of liver metastases; albumin ≥ 2.5 g/dL; creatinine ≤ UNL.
- All acute toxic effects (excluding alopecia) of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.3.0) Grade ≤ 1.
- Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.
- If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.
- Evidence of a personally signed and dated IEC-approved Informed Consent indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Life expectancy of at least 3 months.
- Signed and dated informed consent.
Who cannot join
- Chemotherapy, radiation, hormonotherapy or immunotherapy or participation in any investigational drug study within 4 weeks of RIT treatment at the RD (6 weeks in case of prior nitroureas chemotherapy).
- Prior radiation dose > 30% of bone marrow volume.
- Presence of cirrhosis or active hepatitis.
- Presence of serious cardiac (congestive heart failure, heart insufficiency > grade II NYHA, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorders.
- Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
- Recovery from major trauma including surgery within 4 weeks of administration of study treatment.
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- Pregnancy or lactation or unwillingness to use adequate method of birth control.
- Active infection or incomplete wound healing.
- Known history of allergy to intravenously administered proteins / peptides / antibodies.
- Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Policlinico S. Orsola-Malpighi- Azienda Ospedaliero-Universitaria di Bologna
Bologna
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc)
Meldola
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli
Naples
University Hospital Pisa
Pisa, Tuscany, 56126
ASUR Zona Territoriale 9, Medicina Nucleare Ospedale di Macerata
Province of Macerata
Arcispedale Santa Maria Nuova Di Reggio Emilia
Reggio Emilia
About this study
Official title: A Phase I/II Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer
The aim of this Study Protocol is to provide a basis for the clinical development of 131I-F16SIP as an anti-cancer therapeutic agent.
The study follows and is greatly motivated by the promising results of a Phase I/II study with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian centers.
Read the detailed description
The F16SIP antibody is a fully human antibody, capable of preferential localization around tumour blood vessels while sparing normal tissues. The formation of new blood vessels is a rare event in the adult (exception made for the female reproductive cycle), but is a pathological feature of most aggressive types of cancer. The study aims at determining the therapeutic potential of the F16 antibody in SIP format,labelled with the radionuclide 131I, for the treatment of patients with different cancer types.
- Conditions
- Cancer
- Being tested
- 131I-F16SIP Radioimmunotherapy (RIT)
- Keywords
- I131, F16, antibody, monoclonal, tumor targeting, radioimmunotherapy, lymphoma, breast and lung cancer, Patients with different cancer types
- Medical subject headings
- Neoplasms, Lymphoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131I-F16SIP Radioimmunotherapy (RIT)Drug
- Dosimetric evaluation with 131I-F16SIP or 124I-F16SIP will be performed to assess eligibility for Radioimmunotherapy.
- Patients eligible for Radioimmunotherapy will receive 55.5 mCi/m2 as established in the Phase I part of the study. A single dose of 5 to 10 mg of 131I-F16SIP will be administered intravenously (I.V).
| Study group | Role | What they receive |
|---|---|---|
| I131-F16SIP | Experimental | Phase I: Multicentre, open-label, two-step singlearm dose escalation study in sequential cohorts of patients with cancer.
Phase II: Prospective, open-label, single-arm, multicentre study of 131I-F16SIP, given at the RD of 55.5 mCi/m2, as determined in phase I. Receives: Drug: 131I-F16SIP Radioimmunotherapy (RIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum tolerated Dose
Establishment of the maximum tolerated dose (MTD), a recommended dose (RD) for the phase II part, and the safety of dosimetric and therapeutic administration of escalating dosages of the human radiolabeled antibody 131I-F16SIP.
Measured: 4 weeks
Phase II: Antitumour activity
Investigation of the antitumour activity of 131I-F16SIP at the RD.
Measured: 14 months
Secondary outcomes (5)
Phase I: Study of the variation of radioactivity of 131I or 124I in whole blood, at several time intervals (Pharmacokinetics)
Evaluation of the pharmacokinetics of 131I-F16SIP and 124I-F16SIP.
Measured: 2 days
Phase II: Adverse Events as a Measure of Safety
Determination of the overall safety profile of the iodinated antibody characterized by type, frequency, severity, timing and relationship to study therapy of adverse events and laboratory abnormalities in the first and eventual following administrations in all patients receiving a therapeutic dose.
Measured: 30 days/ administration
Phase II: Overall Response Rate (ORR)
Evaluation of the overall Response Rate (ORR) for all patients having received a therapeutic dose.
Measured: 6 and 12 months
Phase II: Progression free survival (PFS)
Evaluation of the progression free survival (PFS) for all patients having received a therapeutic dose.
Measured: 6 and 12 months
Phase II: Survival rate
Evaluation of the survival rate at 6 and 12 months and overall survival time for all patients having received a therapeutic dose.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startSep 2008
- Primary completionNov 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eudax S.r.l.
- Responsible party
- Sponsor
- Investigators
- Maddalena Sansovini, Dr, Principal investigator, IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240720
- Sponsor's protocol ID
- PH-F16SIPI131-06/07
- Status last verified
- Feb 2014
- First submitted
- 27 Oct 2010
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer
- ClinicalTrials.gov ID
- NCT01240720
- Acronym / sponsor ID
- PH-F16SIPI131-06/07
- Conditions
- Cancer
- Keywords
- I131, F16, antibody, monoclonal, tumor targeting, radioimmunotherapy, lymphoma, breast and lung cancer, Patients with different cancer types
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Eudax S.r.l.
- Study start
- Sep 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Nov 2010 (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 aim of this Study Protocol is to provide a basis for the clinical development of 131I-F16SIP as an anti-cancer therapeutic agent.
The study follows and is greatly motivated by the promising results of a Phase I/II study with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian centers.
Detailed description
The F16SIP antibody is a fully human antibody, capable of preferential localization around tumour blood vessels while sparing normal tissues. The formation of new blood vessels is a rare event in the adult (exception made for the female reproductive cycle), but is a pathological feature of most aggressive types of cancer. The study aims at determining the therapeutic potential of the F16 antibody in SIP format,labelled with the radionuclide 131I, for the treatment of patients with different cancer types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I131-F16SIP | Experimental | Drug: 131I-F16SIP Radioimmunotherapy (RIT)Phase I: Multicentre, open-label, two-step singlearm dose escalation study in sequential cohorts of patients with cancer. Phase II: Prospective, open-label, single-arm, multicentre study of 131I-F16SIP, given at the RD of 55.5 mCi/m2, as determined in phase I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Phase I:
- Patients with cancer, with progressive disease in pre-study period, refractory to conventional standard treatments.
- Solid Tumor: Histologically/cytologically confirmed diagnosis of cancer, preferably lung cancer, prostate cancer or colorectal cancer (CRC). At least one measurable (minimum 2.0 cm), non irradiated lesion defined according to modified RECIST criteria i.e. whenever the measurable disease is restricted to a solitary lesion, its neoplastic nature need not be confirmed by cytology/histology.
- Lymphoproliferative Diseases: Histologically/cytologically confirmed diagnosis of lymphoproliferative disease. At least one measurable (minimum 2.0 cm) non irradiated lesion defined according to modified RECIST criteria, i.e. whenever the measurable disease is restricted to a solitary lesion; its neoplastic nature needs to be confirmed by cytology/histology.
- Patients with lymphoma, breast cancer or lung cancer with progressive disease in pre-study period, refractory to conventional standard treatments, will be enrolled in the study. Presence of brain metastases at time of screening does not represent an exclusion criterion. Lesions will be evaluated according to RECIST for solid tumors or to the Revised response criteria for malignant lymphoma (Cheson BD, JCO 2007, 25, 579-58) for lymphomas.
Key exclusion criteria (10 listed)
- Chemotherapy, radiation, hormonotherapy or immunotherapy or participation in any investigational drug study within 4 weeks of RIT treatment at the RD (6 weeks in case of prior nitroureas chemotherapy).
- Prior radiation dose > 30% of bone marrow volume.
- Presence of cirrhosis or active hepatitis.
- Presence of serious cardiac (congestive heart failure, heart insufficiency > grade II NYHA, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorders.
- Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
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 |
|---|---|---|
| 131I-F16SIP Radioimmunotherapy (RIT)* Dosimetric evaluation with 131I-F16SIP or 124I-F16SIP will be performed to assess eligibility for Radioimmunotherapy. * Patients eligible for Radioimmunotherapy will receive 55.5 mCi/m2 as established in the Phase I part of the study. A single dose of 5 to 10 mg of 131I-F16SIP will be administered intravenously (I.V). | Drug | I131-F16SIP |
Primary outcome
Phase I: Maximum tolerated Dose
Time frame: 4 weeks
Establishment of the maximum tolerated dose (MTD), a recommended dose (RD) for the phase II part, and the safety of dosimetric and therapeutic administration of escalating dosages of the human radiolabeled antibody 131I-F16SIP.
Phase II: Antitumour activity
Time frame: 14 months
Investigation of the antitumour activity of 131I-F16SIP at the RD.
5 secondary outcomes
Phase I: Study of the variation of radioactivity of 131I or 124I in whole blood, at several time intervals (Pharmacokinetics)
Time frame: 2 days
Phase II: Adverse Events as a Measure of Safety
Time frame: 30 days/ administration
Phase II: Overall Response Rate (ORR)
Time frame: 6 and 12 months
Phase II: Progression free survival (PFS)
Time frame: 6 and 12 months
Phase II: Survival rate
Time frame: 6 and 12 months
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 25 Feb 2014.
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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.
Maddalena Sansovini, Dr principal investigator
IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 131I-F16SIP Radioimmunotherapy (RIT) in people with Cancer, run by Philogen S.p.A. at 6 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 16 inclusion and 10 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 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined 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.
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?
Phase I: Maximum tolerated Dose (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2014.