Solid TumorPhase 1/2NCT01134250
Combination Therapy of F16IL2 and Paclitaxel in Solid Tumour Patients
A Phase 1/2 study testing F16IL2 in combination with paclitaxel in people with Solid Tumor and Breast Cancer, run by Philogen S.p.A. at 5 sites in Italy.
Trial summary
This Phase Ib/II study is an open label, multicenter study. The study is divided in two parts: Phase I: an open-label, dose escalation study of F16IL2 in combination with paclitaxel for patients with solid tumours, bladder cancer, breast cancer, metastatic melanoma, mesothelioma, NSCLC, prostate cancer and sarcoma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Breast Cancer, Metastatic Melanoma
- What is being tested?
- F16IL2 in combination with paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesItaly
- Study dates
- 6 Aug 2008to 7 Apr 2014
- 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
- For Phase I, cohorts 1 to 8, of the study:
- For patient of Phase I cohort 1, i.e. those patients receiving F16IL2 alone, patients must not be amenable to therapy with paclitaxel/taxanes but must be considered by the Principal Investigator to be suitable candidates for F16IL2 therapy alone.
- Histologically or cytologically confirmed solid cancer with/without evidence of locally advanced or metastatic disease.
- For advanced solid cancer patients, patients may have received previous chemotherapy or radiation therapy, but they must be amenable for paclitaxel treatment according to the discretion of the principal investigator.
- For Phase I, cohorts 9 onwards:
- Histologically or cytologically confirmed bladder cancer, breast cancer, unresectable metastatic (stage IV) non-uveal melanoma, mesothelioma, NSCLC, prostate cancer or sarcoma.
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- Prior therapies for metastatic disease are allowed, but patients must be amenable for paclitaxel treatment according to the discretion of the principal investigator.
- For breast cancer patients only: patients not suitable for trastuzumab therapy (i.e., no evidence of HER2-overexpressing disease, or trastuzumab therapy exhausted in HER2-overexpressing disease).
- For Phase II of the study:
- Histologically or cytologically confirmed breast cancer, unresectable metastatic (stage IV) non-uveal melanoma, or NSCLC.
- Prior therapies for metastatic disease are allowed, but patients must be amenable for paclitaxel treatment according to the discretion of the principal investigator.
- For breast cancer patients only: patients not suitable for trastuzumab therapy (i.e., no evidence of HER2-overexpressing disease, or trastuzumab therapy exhausted in HER2-overexpressing disease).
- For phase I and II of the study:
- Patients aged ≥ 18 years.
- Prior radiation therapy is allowed, if the irradiated area is not the only source of measurable or assessable disease.
- ECOG performance status ≤ 2
- Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria (see Section APPENDIX A). This lesion must not have been irradiated during previous treatments.
- 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) (v3.0) Grade ≤ 1.
- Sufficient hematologic, liver and renal function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, haemoglobin (Hb) ≥ 9.5 g/dl.
- Alkaline phosphatase (AP), alanine aminotransferase (ALT) and or aspartate aminotransferase ≤ 3 x upper limit of reference range (ULN), and total bilirubin ≤ 2.0 mg/gL unless liver involvement by the tumor, in which case the transaminase levels could be up to 5 x ULN.
- Creatinine ≤ 1.5 ULN or 24 h creatinine clearance ≥ 50 mL/min.
- Life expectancy of at least 12 weeks.
- Documented negative test for human immunodeficiency virus.
- 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 Ethics Committee-approved Informed Consent form 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.
Who cannot join
- For metastatic melanoma patients: Primary ocular melanoma
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, or any cancer curatively treated < 2 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, TIs \& TI).
- Presence of active infections (e.g. requiring antibiotic therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- Presence of known brain metastases. If patient is symptomatic, negative CT scan within two months before study beginning is required. However, presence of controlled brain metastases (i.e., evaluated as SD of PR after radiotherapy) is allowed.
- History of chronic hepatitis B or C, or chronic active hepatitis or active autoimmune diseases.
- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
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- Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
- Irreversible cardiac arrhythmias requiring permanent medication.
- LVEF </= 50% and/or abnormalities observed during baseline MUGA, ECHO or ECG investigations.
- Uncontrolled hypertension.
- Ischemic peripheral vascular disease (Grade IIb-IV).
- Severe rheumatoid arthritis.
- Severe diabetic retinopathy.
- History of allograft or stem cell transplantation.
- Major trauma including surgery within 4 weeks of administration of study treatment.
- Known history of allergy to IL-2, taxanes, or other intravenously administered human proteins/peptides/antibodies.
- Pregnancy or breast feeding. Female patient must agree to use effective contraception, or be surgically sterile or postmenopausal. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- Chemotherapy (standard or experimental) within 4 weeks of the administration of study treatment .
- Radiation therapy within 6 weeks of the administration of study treatment.
- Treatment with an investigational study drug within six weeks before beginning of treatment with F16-IL2.
- Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment.
- Growth factors or immunomodulatory agents within 7 days of the administration of study treatment.
- Neuropathy > Grade 1.
- The chronic administration of low dose corticosteroids is allowed: however the maximum allowed dose per day cannot exceed 5 mg of prednisone (or equivalent) and it is meant to address cancer symptoms (e.g., pain, dyspnoea, lack of appetite). A suspected presence of chronic inflammatory disease has to be considered an exclusion criterion.
- Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
A.O. UNIVERSITARIA OSPEDALI RIUNITI - OSPEDALE UMBERTO I DI ANCONA - ANCONA (AN) (Italy)
Ancona
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc)
Meldola
European Institute of Oncology
Milan, 20141
A.O. UNIVERSITARIA POLICLINICO DI MODENA (Italy)
Modena
Azienda Ospedaliera Universitaria Senese
Siena
About this study
Official title: Phase Ib/II Study of the Tumour-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Paclitaxel in Patients With Advanced Solid Tumours
This Phase Ib/II study is an open label, multicenter study.
The study is divided in two parts:
Phase I: an open-label, dose escalation study of F16IL2 in combination with paclitaxel for patients with solid tumours, bladder cancer, breast cancer, metastatic melanoma, mesothelioma, NSCLC, prostate cancer and sarcoma amenable to taxane therapy.
Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in combination with paclitaxel, equivalent to stage 1 of the Simon two-stage phase II design, for patients with metastatic melanoma, breast cancer and NSCLC amenable to taxane therapy.
Read the detailed description
Breast cancer is a major cause of cancer mortality, second only to lung cancer as a cause of cancer death in women. The five-year survival rate for localized breast cancer has increased from 80 percent in the 1950s to 98 percent today. However, the mortality rate in the most advanced forms remains unsatisfactory. Indeed, the extensive use of mammography within screening programs has led to cancers being detected earlier, when early treatments may be more effective. A greater understanding of the molecular biology and genetic expression of breast cancer has therefore led to new pre-surgical and post-surgical treatments, including hormone modulators and monoclonal antibodies. Many of these agents have led to decreased mortality and disease recurrence.
F16 is a human recombinant antibody fragment in the scFv (single chain Fragment variable) format that is directed against tenascin C, an angiogenesis marker common to most solid tumors independent of the tumor type. ScFv(F16) selectively localizes in tumor tissues in animal models as demonstrated both histologically and during mechanistic studies involving mice transfected with orthotopic human tumours.
IL2, the human cytokine interleukin-2, is a potent stimulator of the immune response. It has a central role in the regulation of T cell responses and effects on other immune cells such as natural killer cells, B cells, monocyte/macrophages and neutrophils (Smith, 1988). IL2 can induce tumor regression through its ability to stimulate a potent cell-mediated immune response in vivo (Rosenberg, 2000).
- Being tested
- F16IL2 in combination with paclitaxel
- Keywords
- Interleukin, IL2, F16, monoclonal, antibody, cytokine Paclitaxel, breast cancer,solid tumour, metastatic melanoma, non-small cell lung cancer (NSCLC)
- Medical subject headings
- Breast Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F16IL2 in combination with paclitaxelDrug
Intravenous (i.v.) infusions of F16IL2 (Dose escalation: from 5 to 35 MioIU, the dose could be further increased until MTD is reached, following a pharmacokinetic-guided design) on days 1, 8, 15, 29, 36 and 43 over 60 minutes via automated device (perfusor), followed by a 1 hour i.v. infusion of paclitaxel (Dose escalation: from 60 up to 90 mg/m2) on days 1, 8, 15, 29, 36 and 43.
Patients with objective tumor responses or stable disease will receive additional combination therapy for a maximum of 6 months, or until disease progression, unacceptable toxicity or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| F16IL2 in combination with paclitaxel | Experimental | Not described Receives: Drug: F16IL2 in combination with paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximum tolerated dose (MTD) and the recommended dose (RD) of F16IL2 when administered in combination with paclitaxel (Phase I).
Safety evaluations performed days 1 through 28, including AEs, SAEs and standard laboratory assessments graded according to the NCI-CTCAE, v3, will be used for determination of dose limiting toxicity (DLT).
Measured: 28 days
To investigate the efficacy of F16IL2, in terms of objective response rate in combination with paclitaxel in metastatic melanoma, breast cancer and NSCLC patients amenable to taxane therapy (Phase II)
The primary efficacy endpoint is the proportion of patients achieving a Tumour Response at week 8.
Measured: 8 weeks
Secondary outcomes (5)
To investigate the safety and tolerability of F16IL2 and paclitaxel when given as a combination (Phase I/II).
Safety and tolerability will be assessed through physical examinations, vital signs, laboratory tests (including serum chemistries, hematology parameters) and the recording of adverse events. Treatment emergent adverse events will be summarized by NCI-CTCAE, version 3. Laboratory values and change in vital signs will be summarized.
Measured: 8 weeks
Investigate pharmacokinetics of F16IL2 and paclitaxel when given as a combination.
In order to investigate the PK profile of F16IL2 and paclitaxel, blood samples for PK measurements in serum will be collected at defined time points during weeks 1 and 2 (after the first dose of study drug) in order to assess accumulation of F16IL2/paclitaxel. PK samples will be collected from all patients enrolled in the phase I part of the study (from cohort 9 onwards, pharmacokinetics of F16IL2 only will be performed), and from the first 5 patients in each indication enrolled in the phase II part of the study.
Measured: 2 weeks
Human anti-fusion protein antibodies
Phase I: To investigate the induction of human anti-fusion protein antibodies (HAFA).
Measured: 18 months
Antitumor activity
To investigate the antitumor activity of the combination of F16IL2 and paclitaxel in solid tumour patients, for cohorts 1 to 8, and in bladder cancer, breast cancer, metastatic melanoma, mesothelioma, non-small cell lung cancer (NSCLC), prostate cancer and sarcoma patients, for cohort 9 onward.
Measured: 12 months
Assessment of median progression-free survival and median overall survival.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study start6 Aug 2008
- Primary completion7 Apr 2014
- Study completion7 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chiara Matilde Catania, Dr, Principal investigator, European Institute of Oncology Milan (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134250
- Sponsor's protocol ID
- PH-F16IL2TAXO-05/07
- Other IDs
- 2007-006457-42
- Status last verified
- Apr 2022
- First submitted
- 25 May 2010
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study of the Tumour-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Paclitaxel in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT01134250
- Acronym / sponsor ID
- PH-F16IL2TAXO-05/07
- Keywords
- Interleukin, IL2, F16, monoclonal, antibody, cytokine Paclitaxel, breast cancer,solid tumour, metastatic melanoma, non-small cell lung cancer (NSCLC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2008 (actual)
- Primary completion
- 7 Apr 2014 (actual)
- Study completion
- 7 Apr 2014 (actual)
- First posted
- 31 May 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.
This Phase Ib/II study is an open label, multicenter study.
The study is divided in two parts:
Phase I: an open-label, dose escalation study of F16IL2 in combination with paclitaxel for patients with solid tumours, bladder cancer, breast cancer, metastatic melanoma, mesothelioma, NSCLC, prostate cancer and sarcoma amenable to taxane therapy.
Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in combination with paclitaxel, equivalent to stage 1 of the Simon two-stage phase II design, for patients with metastatic melanoma, breast cancer and NSCLC amenable to taxane therapy.
Detailed description
Breast cancer is a major cause of cancer mortality, second only to lung cancer as a cause of cancer death in women. The five-year survival rate for localized breast cancer has increased from 80 percent in the 1950s to 98 percent today. However, the mortality rate in the most advanced forms remains unsatisfactory. Indeed, the extensive use of mammography within screening programs has led to cancers being detected earlier, when early treatments may be more effective. A greater understanding of the molecular biology and genetic expression of breast cancer has therefore led to new pre-surgical and post-surgical treatments, including hormone modulators and monoclonal antibodies. Many of these agents have led to decreased mortality and disease recurrence.
F16 is a human recombinant antibody fragment in the scFv (single chain Fragment variable) format that is directed against tenascin C, an angiogenesis marker common to most solid tumors independent of the tumor type. ScFv(F16) selectively localizes in tumor tissues in animal models as demonstrated both histologically and during mechanistic studies involving mice transfected with orthotopic human tumours.
IL2, the human cytokine interleukin-2, is a potent stimulator of the immune response. It has a central role in the regulation of T cell responses and effects on other immune cells such as natural killer cells, B cells, monocyte/macrophages and neutrophils (Smith, 1988). IL2 can induce tumor regression through its ability to stimulate a potent cell-mediated immune response in vivo (Rosenberg, 2000).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F16IL2 in combination with paclitaxel | Experimental | Drug: F16IL2 in combination with paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- For patient of Phase I cohort 1, i.e. those patients receiving F16IL2 alone, patients must not be amenable to therapy with paclitaxel/taxanes but must be considered by the Principal Investigator to be suitable candidates for F16IL2 therapy alone.
- Histologically or cytologically confirmed solid cancer with/without evidence of locally advanced or metastatic disease.
- For advanced solid cancer patients, patients may have received previous chemotherapy or radiation therapy, but they must be amenable for paclitaxel treatment according to the discretion of the principal investigator.
- Histologically or cytologically confirmed bladder cancer, breast cancer, unresectable metastatic (stage IV) non-uveal melanoma, mesothelioma, NSCLC, prostate cancer or sarcoma.
- Prior therapies for metastatic disease are allowed, but patients must be amenable for paclitaxel treatment according to the discretion of the principal investigator.
Key exclusion criteria (25 listed)
- For metastatic melanoma patients: Primary ocular melanoma
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, or any cancer curatively treated < 2 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, TIs \& TI).
- Presence of active infections (e.g. requiring antibiotic therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- Presence of known brain metastases. If patient is symptomatic, negative CT scan within two months before study beginning is required. However, presence of controlled brain metastases (i.e., evaluated as SD of PR after radiotherapy) is allowed.
- History of chronic hepatitis B or C, or chronic active hepatitis or active autoimmune diseases.
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 |
|---|---|---|
| F16IL2 in combination with paclitaxelIntravenous (i.v.) infusions of F16IL2 (Dose escalation: from 5 to 35 MioIU, the dose could be further increased until MTD is reached, following a pharmacokinetic-guided design) on days 1, 8, 15, 29, 36 and 43 over 60 minutes via automated device (perfusor), followed by a 1 hour i.v. infusion of paclitaxel (Dose escalation: from 60 up to 90 mg/m2) on days 1, 8, 15, 29, 36 and 43. Patients with objective tumor responses or stable disease will receive additional combination therapy for a maximum of 6 months, or until disease progression, unacceptable toxicity or withdrawal of consent. | Drug | F16IL2 in combination with paclitaxel |
Primary outcome
To establish the maximum tolerated dose (MTD) and the recommended dose (RD) of F16IL2 when administered in combination with paclitaxel (Phase I).
Time frame: 28 days
Safety evaluations performed days 1 through 28, including AEs, SAEs and standard laboratory assessments graded according to the NCI-CTCAE, v3, will be used for determination of dose limiting toxicity (DLT).
To investigate the efficacy of F16IL2, in terms of objective response rate in combination with paclitaxel in metastatic melanoma, breast cancer and NSCLC patients amenable to taxane therapy (Phase II)
Time frame: 8 weeks
The primary efficacy endpoint is the proportion of patients achieving a Tumour Response at week 8.
5 secondary outcomes
To investigate the safety and tolerability of F16IL2 and paclitaxel when given as a combination (Phase I/II).
Time frame: 8 weeks
Investigate pharmacokinetics of F16IL2 and paclitaxel when given as a combination.
Time frame: 2 weeks
Human anti-fusion protein antibodies
Time frame: 18 months
Antitumor activity
Time frame: 12 months
Assessment of median progression-free survival and median overall survival.
Time frame: 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 15 Apr 2022.
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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.
Chiara Matilde Catania, Dr principal investigator
European Institute of Oncology Milan (Italy)
5 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 F16IL2 in combination with paclitaxel in people with Solid Tumor and Breast Cancer, run by Philogen S.p.A. at 5 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 28 inclusion and 25 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 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
To establish the maximum tolerated dose (MTD) and the recommended dose (RD) of F16IL2 when administered in combination with paclitaxel (Phase I). (time frame: 28 days). 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 15 Apr 2022.