LeiomyosarcomaPhase 2FIBROSARC USNCT03420014
Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)
A Phase 2 study testing Doxorubicin and L19TNF plus doxorubicin in people with Leiomyosarcoma, run by Philogen S.p.A. at 8 sites in United States.
Trial summary
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Leiomyosarcoma
- What is being tested?
- Doxorubicin and L19TNF plus doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Dec 2018to Dec 2025
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be included in the study if they meet all of the following criteria:
- Age ≥ 16 years. Patients under 18 years, should be fully grown (proof of fused growth plates).
- Patients with histological evidence of stage IV metastatic high-grade leiomyosarcoma (grade 2 - 3 according to the Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) grading system) not amenable to curative treatment with surgery or radiotherapy.
- Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1. If only 1 lesion is present at screening this lesion should not have been irradiated during previous treatments.
- Life expectancy of at least 3 months in the judgment of the investigator.
- ECOG ≤ 1.
Show all 12Show fewer
- Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
- Female patients: negative serum pregnancy test for women of childbearing potential (WOCBP)* within 14 days of starting treatment. WOCBP must agree to use, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
- Male patients: Male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g., condom with spermicidal gel). Double-barrier contraception is required.
- Informed consent signed and dated to participate in the study.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
Who cannot join
- Patients will be excluded from participating in this study if they meet one or more of the following criteria:
- Prior therapy (except surgery and radiation) for unresectable or metastatic malignant soft tissue sarcoma (STS).
- Patients with primary tumor localized to the extremities and a single resectable synchronous distant metastatic lesion.
- Patients eligible for neoadjuvant preoperative treatment.
- Previous treatment with anthracycline-containing chemotherapy.
- Radiotherapy within 4 weeks prior to start of therapy.
Show all 35Show fewer
- Known history of allergy to TNFα, anthracyclines or other intravenously (IV) administered human proteins/peptides/antibodies.
- Absolute neutrophil count (ANC) < 1.5 x 109/L, platelets < 100 x 109/L and haemoglobin (Hb) < 9.0 g/dl.
- Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN.
- Inadequate liver function (ALT, AST, GGT, ALP or total bilirubin ≥ 1.5 x ULN) or total bilirubin ≥ 1.5 x ULN).
- International normalized ratio (INR) > 1.5 ULN.
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- History within the last year of cerebrovascular disease and/or acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- Heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
- Left Ventricular Ejection Fraction (LVEF) < 50%.
- Clinically significant cardiac arrhythmias or requiring permanent medication.
- Abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current, or a history of QT/QTc prolongation would be excluded. In particular:
- patients with a marked prolongation of QT/QTc interval (e.g., repeated demonstration of QTc >480 milliseconds using Fredricia's QT correction formula) are excluded;
- patients with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of prolonged QT syndrome) are excluded;
- patients who require the use of concomitant medications that prolong the QT/QTc interval are excluded.
- Uncontrolled hypertension, despite optimal therapy.
- Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
- Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
- Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
- Pregnancy or breast-feeding.
- Requirement of chronic administration of corticosteroids or other immunosuppressant drugs. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
- Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- Known active or latent tuberculosis (TB).
- Concurrent malignancies other than soft tissue sarcoma (STS), unless the patient has been disease-free for at least 2 years.
- Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
- Serious, non-healing wound, ulcer or bone fracture.
- Allergy to study medication or excipients in study medication.
- Concurrent therapy with anticoagulants.
- Concurrent use of other anti-cancer treatments or agents other than study medication.
- Any recent live vaccination within 4 weeks prior to treatment or plan to receive vaccination during the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43202
David A Liebner, MD
- Recruiting
Mayo Clinic Hospital
Jacksonville, Florida, 32224
Steven Attia, MD, 904-953-7292, Attia.steven@mayo.edu
- Recruiting
Rutgers Cancer Institute of New Jersey 195 Little Albany Street New Brunswick, NJ 08901 Room 2031
New Brunswick, New Jersey, 08901
Sarah Weiss, MD
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Mahesh Seetharam, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Scott Okuno, MD
- Recruiting
Sarcoma Oncology Research Center (SORC) Cancer Center of Southern California
Santa Monica, California, 90403
Sant P Chawla, MD
- Recruiting
Seattle Cancer Care Alliance 825 Eastlake Ave. E. Seattle, WA 98109 Mail Stop CE2-128
Seattle, Washington, 98109
Lee Cranmer, MD
- Recruiting
Washington University
St Louis, Missouri, 63110
Mia Weiss, MD
About this study
Official title: A Randomized Study Comparing the Efficacy of the Combination of Doxorubicin and the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF to Doxorubicin Alone as First-line Therapy in Patients With Metastatic Leiomyosarcoma
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients.
Read the detailed description
In the study, 122 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2).
The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for metastatic leiomyosarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1).
Anti-cancer activity will be assessed every 6 weeks during therapy and every 12 weeks thereafter.
- Conditions
- Leiomyosarcoma
- Being tested
- Doxorubicin, L19TNF plus doxorubicin
- Medical subject headings
- Leiomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
75 mg/m2 doxorubicin will be administered once every 3 weeks (Day 1 of every 21-days cycle).
L19TNF plus doxorubicinCombination product
13 μg/kg L19TNF will be administered on day 1, 3 and 5 of every 21-days cycle in combination with 60 mg/m2 doxorubicin on day 1 of every 21-days cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Doxorubicin | Active comparator | Patients will receive a fixed dose doxorubicin, administered as a 15 ± 5 minutes i.v. infusion. Receives: Drug: Doxorubicin |
| Arm 2: L19TNF plus doxorubicin | Experimental | Patients will receive a fixed dose of L19TNF in combination with a fixed dose doxorubicin.
Doxorubicin will be administered as a 15 ± 5 minutes i.v. infusion on day 1 of each 21-day cycle followed by at least 30 minutes pause before starting infusion of L19TNF. Receives: Combination Product: L19TNF plus doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression-free survival PFS in a time-to-event analysis in the L19TNF plus Doxorubicin control group (Arm 2) versus the Doxorubicin alone treatment group (Arm 1).
Measured: From randomization up to week 72
Secondary outcomes (19)
Overall survival (OS)
Overall survival (OS) in the L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1) will be evaluated in time to event analysis.
Measured: From week 1 up to week 72, every 6 weeks; from week 73 up to week 144, every 12 weeks;
Overall response rate (ORR)
Overall Response Rate (ORR) assessed by BIRC, i.e. rate of CR and PR of L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1).
Measured: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.
Duration of response (DOR)
Duration of Response (DOR) assessed by BIRC in the L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1).
Measured: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.
Progression-free survival (PFS) rate
PFS rate of L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1).
Measured: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.
Overall survival (OS) rates
Overall survival (OS) rates in the L19TNF plus Doxorubicin treatment group (Arm 2) versus Doxorubicin alone (Arm 1).
Measured: From week 1 up to week 144.
Number of patients with adverse events (AEs).
Measured: From week 1 up to week 72.
Percentage of participants with worst on-study hematological and chemistry abnormalities.
Measured: From week 1 up to week 72.
Percentage of participants with Electrocardiogram (ECG) and Echocardiogram (ECHO) abnormality findings.
Measured: From week 1 up to week 72, every 6 weeks.
Number of Participants With Clinically Significant Abnormalities in Vital Signs (Systolic and Diastolic Blood Pressure, Temperature, Heart Rate).
Measured: From week 1 up to week 72.
Number of Participants With Clinically Significant Physical Examination Abnormalities (General Appearance, Skin, Eyes, Ears-Nose-Throat, Breast, Head and Neck, Lungs, Heart, Abdomen, Lymph Nodes, Musculoskeletal)
Measured: From week 1 up to week 72.
Human anti-fusion protein antibodies (HAFA) levels against L19TNF.
Measured: At day 1 of week 1 and week 2; at day 1 from week 4 up to week 18, every 3 weeks; at week 22-23 (EoT); at week 23-24 (first follow-up visit)
Maximum drug concentration [Cmax].
Pharmacokinetics assessment of L19TNF through blood sampling.
Measured: At day 1, 2 ,3 and 5 of week 1
Time to reach maximum drug concentration [Tmax].
Pharmacokinetics assessment of L19TNF through blood sampling.
Measured: At day 1, 2 ,3 and 5 of week 1
Terminal half-life [t1/2].
Pharmacokinetics assessment of L19TNF through blood sampling.
Measured: At day 1, 2 ,3 and 5 of week 1
Area under the drug concentration-time curve, extrapolated to infinity [AUC].
Pharmacokinetics assessment of L19TNF through blood sampling.
Measured: At day 1, 2 ,3 and 5 of week 1
Maximum drug concentration [Cmax].
Pharmacokinetics assessment of doxorubicin through blood sampling.
Measured: At day 1, 2 ,3 and 5 of week 1
Time to reach maximum drug concentration [Tmax].
Pharmacokinetics assessment of doxorubicin through blood sampling.
Measured: At day 1, 2 ,3 and 5 of week 1
Terminal half-life [t1/2].
Pharmacokinetics assessment of doxorubicin through blood sampling.
Measured: At day 1, 2 ,3 and 5 of week 1
Area under the drug concentration-time curve, extrapolated to infinity [AUC].
Pharmacokinetics assessment of doxorubicin through blood sampling.
Measured: At day 1, 2 ,3 and 5 of week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start27 Dec 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyosarcomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott H. Okuno, M.D., Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420014
- Sponsor's protocol ID
- PH-L19TNFDOX2-02/17
- Acronym
- FIBROSARC US
- Status last verified
- Oct 2023
- First submitted
- 12 Jan 2018
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing the Efficacy of the Combination of Doxorubicin and the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF to Doxorubicin Alone as First-line Therapy in Patients With Metastatic Leiomyosarcoma
- ClinicalTrials.gov ID
- NCT03420014
- Acronym / sponsor ID
- FIBROSARC US / PH-L19TNFDOX2-02/17
- Conditions
- Leiomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Feb 2018 (actual)
- 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 present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients.
Detailed description
In the study, 122 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2).
The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for metastatic leiomyosarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1).
Anti-cancer activity will be assessed every 6 weeks during therapy and every 12 weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Doxorubicin | Active comparator | Drug: DoxorubicinPatients will receive a fixed dose doxorubicin, administered as a 15 ± 5 minutes i.v. infusion. |
| Arm 2: L19TNF plus doxorubicin | Experimental | Combination Product: L19TNF plus doxorubicinPatients will receive a fixed dose of L19TNF in combination with a fixed dose doxorubicin. Doxorubicin will be administered as a 15 ± 5 minutes i.v. infusion on day 1 of each 21-day cycle followed by at least 30 minutes pause before starting infusion of L19TNF. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 16 years. Patients under 18 years, should be fully grown (proof of fused growth plates).
- Patients with histological evidence of stage IV metastatic high-grade leiomyosarcoma (grade 2 - 3 according to the Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) grading system) not amenable to curative treatment with surgery or radiotherapy.
- Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1. If only 1 lesion is present at screening this lesion should not have been irradiated during previous treatments.
- Life expectancy of at least 3 months in the judgment of the investigator.
- ECOG ≤ 1.
Key exclusion criteria (35 listed)
- Patients will be excluded from participating in this study if they meet one or more of the following criteria:
- Prior therapy (except surgery and radiation) for unresectable or metastatic malignant soft tissue sarcoma (STS).
- Patients with primary tumor localized to the extremities and a single resectable synchronous distant metastatic lesion.
- Patients eligible for neoadjuvant preoperative treatment.
- Previous treatment with anthracycline-containing chemotherapy.
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 |
|---|---|---|
| Doxorubicin75 mg/m2 doxorubicin will be administered once every 3 weeks (Day 1 of every 21-days cycle). | Drug | Arm 1: Doxorubicin |
| L19TNF plus doxorubicin13 μg/kg L19TNF will be administered on day 1, 3 and 5 of every 21-days cycle in combination with 60 mg/m2 doxorubicin on day 1 of every 21-days cycle. | Combination product | Arm 2: L19TNF plus doxorubicin |
Primary outcome
Progression free survival (PFS)
Time frame: From randomization up to week 72
Progression-free survival PFS in a time-to-event analysis in the L19TNF plus Doxorubicin control group (Arm 2) versus the Doxorubicin alone treatment group (Arm 1).
19 secondary outcomes
Overall survival (OS)
Time frame: From week 1 up to week 72, every 6 weeks; from week 73 up to week 144, every 12 weeks;
Overall response rate (ORR)
Time frame: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.
Duration of response (DOR)
Time frame: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.
Progression-free survival (PFS) rate
Time frame: 1) From week 1 up to week 18, every 6 weeks; 2) from week 19 up to week 72, every 12 weeks (Maintenance); 3) EoT: at week 22/23 (only Induction) and at week 72 (Maintenance); 4) Follow-up: from week 22/23 (EoT) up to week 72, every 12 weeks.
Overall survival (OS) rates
Time frame: From week 1 up to week 144.
Number of patients with adverse events (AEs).
Time frame: From week 1 up to week 72.
Percentage of participants with worst on-study hematological and chemistry abnormalities.
Time frame: From week 1 up to week 72.
Percentage of participants with Electrocardiogram (ECG) and Echocardiogram (ECHO) abnormality findings.
Time frame: From week 1 up to week 72, every 6 weeks.
Number of Participants With Clinically Significant Abnormalities in Vital Signs (Systolic and Diastolic Blood Pressure, Temperature, Heart Rate).
Time frame: From week 1 up to week 72.
Number of Participants With Clinically Significant Physical Examination Abnormalities (General Appearance, Skin, Eyes, Ears-Nose-Throat, Breast, Head and Neck, Lungs, Heart, Abdomen, Lymph Nodes, Musculoskeletal)
Time frame: From week 1 up to week 72.
Human anti-fusion protein antibodies (HAFA) levels against L19TNF.
Time frame: At day 1 of week 1 and week 2; at day 1 from week 4 up to week 18, every 3 weeks; at week 22-23 (EoT); at week 23-24 (first follow-up visit)
Maximum drug concentration [Cmax].
Time frame: At day 1, 2 ,3 and 5 of week 1
Time to reach maximum drug concentration [Tmax].
Time frame: At day 1, 2 ,3 and 5 of week 1
Terminal half-life [t1/2].
Time frame: At day 1, 2 ,3 and 5 of week 1
Area under the drug concentration-time curve, extrapolated to infinity [AUC].
Time frame: At day 1, 2 ,3 and 5 of week 1
Maximum drug concentration [Cmax].
Time frame: At day 1, 2 ,3 and 5 of week 1
Time to reach maximum drug concentration [Tmax].
Time frame: At day 1, 2 ,3 and 5 of week 1
Terminal half-life [t1/2].
Time frame: At day 1, 2 ,3 and 5 of week 1
Area under the drug concentration-time curve, extrapolated to infinity [AUC].
Time frame: At day 1, 2 ,3 and 5 of week 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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.
Scott H. Okuno, M.D. principal investigator
Mayo Clinic, Rochester, MN
8 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 Doxorubicin and L19TNF plus doxorubicin in people with Leiomyosarcoma, run by Philogen S.p.A. at 8 sites in United States.
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 35 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Hemmerle, PhD (+39 057717816, regulatory@philogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: From randomization up to week 72). 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 10 Oct 2023.