Sarcoma of the ExtremityPhase 1/2NCT04220229
Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities
A Phase 1/2 study testing Cabozantinib S-malate and Radiation Therapy in people with Sarcoma of the Extremity and Stage I Soft Tissue Sarcoma of the Trunk and Extremities, run by University of Washington at 1 site in United States.
Trial summary
This phase I/II trial studies the side effects and best dose of cabozantinib when given with radiation therapy and how well it works in treating patients with sarcoma of the extremities. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma of the Extremity, Stage I Soft Tissue Sarcoma of the Trunk and Extremities, Stage IA Soft Tissue Sarcoma of the Trunk and Extremities
- What is being tested?
- Cabozantinib S-malate and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects, >= 18 years old, must have a histologically confirmed diagnosis of sarcomas of the extremities (which may include gluteal muscle involvement) for which neoadjuvant radiation therapy followed by surgical resection is a planned intervention
- Subjects whose bowel cannot be completely protected from radiation exposure due to primary tumor location (e.g., proximal lower extremity) will be excluded
- Subjects must have one or more measurable target lesions by RECIST version (v) 1.1, assessed via computed tomography (CT) scan or magnetic resonance imaging (MRI)
- At the time of study enrollment, subjects must have a tumor burden that is judged to be surgically resectable
- Absolute neutrophil count (ANC) >= 1500/mm^3 (>= 1.5 GI/L) without granulocyte colony-stimulating factor support in the last 28 days
- White blood cell count >= 2500/mm^3 (>= 2.5 GI/L)
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- Platelets >= 100,000/mm^3 (>=100 GI/L) without transfusion in the last 28 days
- Hemoglobin >= 9 g/dL (>= 90 g/L) without transfusion in the last 28 days
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =< 3 X upper limit of normal (ULN)
- Alkaline phosphatase (ALP) =< 3 X upper limit of normal (ULN)
- ALP =< 5 X ULN is permitted in subjects with documented bone metastases (phase 1 only)
- Total bilirubin =< 1.5 x ULN (for subjects with Gilbert's disease =< 3 X ULN)
- Serum albumin >= 2.8 g/dl
- Serum creatinine =< 2.0 x ULN or calculated creatinine clearance >= 30 mL/min (>= 0.5 mL/sec) using the Cockcroft-Gault equation
- Urine protein/creatinine ratio (UPCR) =< 1 mg/mg (=< 113.2 mg/mmol)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Male or non-pregnant and non-breast feeding female:
- Females of child-bearing potential must agree to use highly effective contraception without interruption from initiation of therapy and while on study medication and have a negative serum pregnancy test (beta-human chorionic gonadotropin [B-hCG]) result at screening and agree to ongoing pregnancy testing during the study, and at the end of study treatment. A highly effective method of contraception is defined as one that results in a low failure rate (that is, < 1% per year), when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
- Male subjects must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study
- Life expectancy of > 3 months, as determined by the investigator
- Ability to understand and sign informed consent
- Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures
Who cannot join
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) for the investigational diagnosis
- Receipt of any prior radiation therapy for the investigational diagnosis
- Known central nervous system (CNS) metastases
- Concomitant anticoagulation with oral anticoagulants(e.g., warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
- Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted
- Low-dose low molecular weight heparins (LMWH) are permitted
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- Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor. Subjects with hemoptysis, central nervous system hemorrhage or gastrointestinal hemorrhage within the last 6 months prior to treatment are excluded
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias
- Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal anti-hypertensive treatment
- Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose.
- Uncontrolled serious medical or psychiatric illness
- Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
- The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction
- Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose
- Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose
- Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose
- Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation
- Lesions invading or encasing any major blood vessels
- Other clinically significant disorders that would preclude safe study participation
- Serious non-healing wound/ulcer/bone fracture
- Uncompensated/symptomatic hypothyroidism
- Moderate to severe hepatic impairment (Child-Pugh B or C)
- Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred at least 30 days before first dose, and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
- Corrected QT interval calculated by the Bazett's formula (corrected QT [QTc]) > 480 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment
- Note: If a single ECG shows a QTc with an absolute value > 480 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTc will be used to determine eligibility
- Pregnant or lactating females
- Inability to swallow tablets
- Previously identified allergy or hypersensitivity to components of the study treatment formulations
- Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy
- Concurrent use of medications (especially those interacting with CYP3A417) that potentially interact unsafely with cabozantinib which cannot be discontinued or substituted
- Subjects with a sarcoma which has other, defined treatments or biology distinctly different from those of soft tissue sarcomas in general. Including, but not limited to, Ewing's sarcoma, rhabdomyosarcoma, gastrointestinal stromal tumors, Kaposi's sarcoma, Wilms' tumor
- Transfusion of blood product or granulocyte-colony stimulating factor (G-CSF) support factor within the last 28 days
- Recent infection requiring systemic anti-infective treatment that was completed =< 14 days prior to enrollment (except for uncomplicated urinary tract infection or upper respiratory tract infection)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Phase 1/2 Study of Neoadjuvant Cabozantinib in Combination With Radiation Therapy for Sarcomas of the Extremities
This phase I/II trial studies the side effects and best dose of cabozantinib when given with radiation therapy and how well it works in treating patients with sarcoma of the extremities. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cabozantinib with radiation therapy may make the tumors smaller and reduce the amount of normal tissue that needs to be removed.
Read the detailed description
OUTLINE: This is a phase I, dose-escalation study of cabozantinib followed by a phase II, dose-expansion study.
Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning Cycle 1 Day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
After completion of study treatment, patients are followed up at 30 days, every 12 weeks for up to 1 year, then every 6 months for up to 3 years.
- Conditions
- Sarcoma of the Extremity, Stage I Soft Tissue Sarcoma of the Trunk and Extremities, Stage IA Soft Tissue Sarcoma of the Trunk and Extremities, Stage IB Soft Tissue Sarcoma of the Trunk and Extremities, Stage II Soft Tissue Sarcoma of the Trunk and Extremities
- Being tested
- Cabozantinib S-malate, Radiation Therapy
- Keywords
- Soft Tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabozantinib S-malateDrug
Also called 1140909-48-3, BMS-907351, Butanedioic acid, Cabometyx
Given PO
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, irradiated, Irradiation
Undergo standard of care radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cabozantinib S-malate, radiation therapy) | Experimental | Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks. Receives: Drug: Cabozantinib S-malate; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose of Cabozantinib S-malate (Cabozantinib) (Phase I)
Cabozantinib treatment begins 8 days prior to initiation of radiation therapy and continues through completion of radiation therapy.
Measured: Up to 21 days
Rate of Relapse (Phase II)
No patients were enrolled in Phase II portion of study - outcome measure based on Phase I patients.
Measured: At 12 months after treatment initiation
Secondary outcomes (9)
Rate of Pathologic Response(>90%)
Evaluated utilizing the Exact Clopper-Pearson method.
Measured: Up to 1 year
Rate of Surgical Excision With Negative Margins
Evaluated utilizing the Exact Clopper-Pearson method.
Measured: Up to 1 year
Objective Response Rate
Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Includes those who had complete response and partial response.
Measured: Up to 1 year
Rate of Local Relapse
Evaluated utilizing the Exact Clopper-Pearson method.
Measured: Up to 3 years
Rate of Distant Relapse
Evaluated utilizing the Exact Clopper-Pearson method.
Measured: Up to 3 years
Relapse-free Survival
Evaluated utilizing the Exact Clopper-Pearson method.
Measured: Up to 1 year
Overall Survival
Evaluated utilizing the Exact Clopper-Pearson method.
Measured: Up to 1 year
Incidence of Adverse Events - Treatment-related Adverse Events (AEs) Experienced by Participants Evaluated by CTCAE 5.0 and Determined to be Possibly Related, Probably Related, or Definitely Related to Cabozantinib.
Adverse events will be graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Measured: Up to 30 days after last dose of investigational product (an average of up to 12 weeks)
Rate of Treatment Discontinuation Prior to Neoadjuvant Radiation Therapy
Evaluated utilizing the Exact Clopper-Pearson method.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Jun 2020
- Primary completion5 Apr 2024
- Study completion31 Oct 2024
Why it stopped: Terminated due to end of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoma of the ExtremityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Exelixis
- Responsible party
- Principal investigator, Lee Duncan Cranmer, University of Washington
- Investigators
- Lee Cranmer, MD, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220229
- Sponsor's protocol ID
- RG1003562
- Other IDs
- NCI-2019-08661, 10051
- Status last verified
- Jun 2025
- First submitted
- 3 Jan 2020
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.
PubMed 32827353
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Neoadjuvant Cabozantinib in Combination With Radiation Therapy for Sarcomas of the Extremities
- ClinicalTrials.gov ID
- NCT04220229
- Acronym / sponsor ID
- RG1003562
- Conditions
- Sarcoma of the Extremity, Stage I Soft Tissue Sarcoma of the Trunk and Extremities, Stage IA Soft Tissue Sarcoma of the Trunk and Extremities, Stage IB Soft Tissue Sarcoma of the Trunk and Extremities, Stage II Soft Tissue Sarcoma of the Trunk and Extremities
- Keywords
- Soft Tissue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to end of funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Exelixis
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the side effects and best dose of cabozantinib when given with radiation therapy and how well it works in treating patients with sarcoma of the extremities. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cabozantinib with radiation therapy may make the tumors smaller and reduce the amount of normal tissue that needs to be removed.
Detailed description
OUTLINE: This is a phase I, dose-escalation study of cabozantinib followed by a phase II, dose-expansion study.
Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning Cycle 1 Day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.
After completion of study treatment, patients are followed up at 30 days, every 12 weeks for up to 1 year, then every 6 months for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cabozantinib S-malate, radiation therapy) | Experimental | Drug: Cabozantinib S-malate, Radiation: Radiation TherapyPatients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Subjects, >= 18 years old, must have a histologically confirmed diagnosis of sarcomas of the extremities (which may include gluteal muscle involvement) for which neoadjuvant radiation therapy followed by surgical resection is a planned intervention
- Subjects must have one or more measurable target lesions by RECIST version (v) 1.1, assessed via computed tomography (CT) scan or magnetic resonance imaging (MRI)
- At the time of study enrollment, subjects must have a tumor burden that is judged to be surgically resectable
- Absolute neutrophil count (ANC) >= 1500/mm^3 (>= 1.5 GI/L) without granulocyte colony-stimulating factor support in the last 28 days
- White blood cell count >= 2500/mm^3 (>= 2.5 GI/L)
Key exclusion criteria (35 listed)
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) for the investigational diagnosis
- Receipt of any prior radiation therapy for the investigational diagnosis
- Known central nervous system (CNS) metastases
- Concomitant anticoagulation with oral anticoagulants(e.g., warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
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 |
|---|---|---|
| Cabozantinib S-malateAlso: 1140909-48-3, BMS-907351, Butanedioic acid, CabometyxGiven PO | Drug | Treatment (cabozantinib S-malate, radiation therapy) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, irradiated, IrradiationUndergo standard of care radiation therapy | Radiation | Treatment (cabozantinib S-malate, radiation therapy) |
Primary outcome
Recommended Phase 2 Dose of Cabozantinib S-malate (Cabozantinib) (Phase I)
Time frame: Up to 21 days
Cabozantinib treatment begins 8 days prior to initiation of radiation therapy and continues through completion of radiation therapy.
Rate of Relapse (Phase II)
Time frame: At 12 months after treatment initiation
No patients were enrolled in Phase II portion of study - outcome measure based on Phase I patients.
9 secondary outcomes
Rate of Pathologic Response(>90%)
Time frame: Up to 1 year
Rate of Surgical Excision With Negative Margins
Time frame: Up to 1 year
Objective Response Rate
Time frame: Up to 1 year
Rate of Local Relapse
Time frame: Up to 3 years
Rate of Distant Relapse
Time frame: Up to 3 years
Relapse-free Survival
Time frame: Up to 1 year
Overall Survival
Time frame: Up to 1 year
Incidence of Adverse Events - Treatment-related Adverse Events (AEs) Experienced by Participants Evaluated by CTCAE 5.0 and Determined to be Possibly Related, Probably Related, or Definitely Related to Cabozantinib.
Time frame: Up to 30 days after last dose of investigational product (an average of up to 12 weeks)
Rate of Treatment Discontinuation Prior to Neoadjuvant Radiation Therapy
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32827353Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.
- Individual participant dataSharing planned: No
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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.
Lee Cranmer, MD, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site 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 Cabozantinib S-malate and Radiation Therapy in people with Sarcoma of the Extremity and Stage I Soft Tissue Sarcoma of the Trunk and Extremities, run by University of Washington at 1 site 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 22 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: stopped early, as of the sponsor's last update on 17 Jul 2025. 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 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 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?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recommended Phase 2 Dose of Cabozantinib S-malate (Cabozantinib) (Phase I) (time frame: Up to 21 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?
On the ClinicalTrials.gov record for NCT04220229, 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 17 Jul 2025.