Acute Myeloid LeukemiaPhase 2RADIUSNCT01883362

Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

A Phase 2 study testing Midostaurin in people with Acute Myeloid Leukemia, run by Novartis Pharmaceuticals at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant, Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Acute Myeloid Leukemia
What is being tested?: Midostaurin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 19 sitesin 2 countries
Study dates: 6 Feb 2014to 30 Apr 2018
Phase: Phase 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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 18 and 70 years of age
Patients with ECOG Performance Status of ≤ 2
Patients with a documented unequivocal diagnosis of AML according to WHO 2008 classification (>20% blasts in the bone marrow), excluding M3 (acute promyelocytic leukemia).
Patients with a documented FLT3 ITD mutation, determined by local laboratory for eligibility (historical tissue will be requested for central analysis confirmation)
Patients who undersent allogeneic HSCT in CR1 from a matched related or matched unrelated donor. All of the following criteria had to be met: HLA typing to include available 8/8 or 7/8 allele HLA matched donor (at A,B,C, DRB1) Single allelic mismatch allowed
Patients who had received a conditioning regimen which included one of the following:
Busulfan/Fludarabine (Bu/Flu) Busulfan (16 mg/kg PO or 12.8 mg/kg IV) Fludarabine (120-180 mg/m2) Fludarabine / Melphalan (Flu/Mel) Fludarabine (120-180 mg/m2) Melphalan (≤ 150 mg/m2) Busulfan/Cyclophosphamide (Bu/Cy) Busulfan (16 mg/kg PO or 12.8 mg/kg IV) Cyclophosphamide (120 mg/kg) Cyclophosphamide/Total Body Irradiation (Cy/TBI) Cyclophosphamide (120 mg/kg) TBI (1200-1420 cGy)
Recovery of counts by day 42 and was able to start midostaurin by day 60 post-HSCT (first dose of midostaurin to start no earlier than 28 days post-HSCT); ANC >1000µL, platelets ≥20,000 without platelet transfusion

Who cannot join

Patients eligible for this study must not have met any of the following criteria:
Patients who failed prior attempts at allogeneic HSCT
Patients who had received an autologous transplant
Patients with Acute GVHD Grade III-IV
Patients with a known confirmed diagnosis of HIV infection or active viral hepatitis.
Impaired cardiac function including any of the following:

Show all 18Show fewer

Screening ECG with a QTc > 450 msec. If QTc > 450 and electrolytes were not within normal ranges, electrolytes should be corrected and then the patient rescreened for QTc.
Patients with congenital long QT syndrome
History or presence of sustained ventricular tachycardia
Any history of ventricular fibrillation or torsades de pointes
Bradycardia defined as HR. < 50 bpm
Right bundle branch block + left anterior hemiblock (bifascicular block)
Patients with myocardial infarction or unstable angina < 6 months prior to starting study
Congestive Heart Failure NY Heart Association class III or IV
Patients with an ejection fraction < 45% assessed by MUGA or ---ECHO within 28 days prior to starting study cycle 1 (of midostaurin or control group)
Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolves to ≤ Grade 1 within screening timeframe)
Patient required treatment with strong CYP3A4 inhibitors or moderate or strong CYP3A4 inducers other than those required for GVH or infection prophylaxis or treatment
Pregnant or nursing (lactating) women, or women of child-bearing potential, must have used highly effective methods of contraception during dosing and for 30 days after treatment completion

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

United States18 sites

Northside Hospital
Atlanta, Georgia, 30342
University of North Carolina at Chapel Hill University of North Carolina 6
Chapel Hill, North Carolina, 27599-9500
University of Chicago Medical Center
Chicago, Illinois, 60637
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Baylor Health Care System/Sammons Cancer Center Oncology
Dallas, Texas, 75246
SCRI- Colorado Blood Cancer Institute
Denver, Colorado, 80218
Karmanos Cancer Institute Karmanos - Wayne State
Detroit, Michigan, 48201
Hackensack University Medical Center Hackensack Univ Med Ctr (32)
Hackensack, New Jersey, 07601
University of California San Diego Moores Cancer Center
La Jolla, California, 92093-0987
University of California at Los Angeles Oncology
Los Angeles, California, 90095
Tennessee Oncology Sarah Cannon Research Inst.
Nashville, Tennessee, 37203
Vanderbilt Univeristy Oncology
Nashville, Tennessee, 37232
Oregon Health Sciences University
Portland, Oregon, 97239
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Texas Transplant Physicians Group Oncology 2
San Antonio, Texas, 78229
Fred Hutchinson Cancer Research Center Oncology
Seattle, Washington, 98109
Washington University School Of Medicine-Siteman Cancer Ctr Washington U School of Med
St Louis, Missouri, 63110
H Lee Moffitt Cancer Center and Research Institute Oncology
Tampa, Florida, 33612

Other trials in United States

Canada1 site

Novartis Investigative Site
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II, Randomized Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia

To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,

Conditions: Acute Myeloid Leukemia
Being tested: Midostaurin, Standard of Care
Keywords: acute myeloid leukemia, AML, FLT3-ITD, midostaurin, PKC412, allogeneic hematopoeitic stem cell tranplant, SCT, HSCT, CR1, adult
Medical subject headings: Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MidostaurinDrug
Also called PKC412
Midostaurin was supplied in 25mg soft gelatin capsule taken orally twice a day for 28 days of each cycle. Patients will be treated for 12 cycles.
Standard of CareOther
Standard of Care was not defined per protocol. The investigator prescribed based on the commonly used medications given in the post SCT setting.

Study groups in NCT01883362
Study group	Role	What they receive
Standard of Care with Midostaurin	Experimental	Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles). Receives: Drug: Midostaurin
Standard of Care	Active comparator	Patients received standard of care alone in the post SCT setting Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis
Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.
Measured: date of transplant up to 18 months

Secondary outcomes (7)

Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis
Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.
Measured: Randomization to 18 months
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis
DFS was defined as the time from transplant to relapse or death due to any cause. If a patient had more than 1 event (e.g., relapse then death) then the earliest date was taken into account.
Measured: date of transplant up to 24 months
Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis
Relapse-free survival was defined as the time from transplant to relapse or death due to the disease 24 months post-transplant. If a patient had more than one event (e.g., relapse then death) then the earliest date was taken into account.
Measured: date of transplant up to 24 months
Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
Overall survival was defined as the time from transplant to death due to any cause.
Measured: date of transplant up to 24 months
Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
Non-relapse mortality (NRM) was defined as the time from transplant to death due to reasons other than relapse/progressive disease
Measured: date of transplant up to 24 months
FLT3-ITD Mutation Status Centrally in Archived Material From Diagnosis (if Available) Including Mutant:Wild Type Ratio.
Unable to retrieve a sufficient amount of archived samples to perform an analysis therefore the study was not able to verify the FLT3-ITD mutation status
Measured: up to 24 months from date of transplannt or at study completion
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Pre-dose levels (Cmin) will be directly determined from raw plasma concentration-time data. Values below the lower limit of quantification (LLOQ) will be treated as zero in any calculations of summary statistics.
Measured: Pre-dose on days 1 and 15 of Cycle 1, on day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 201430 Apr 2018

First posted21 Jun 2013 (estimated)
Study start6 Feb 2014
Primary completion30 Apr 2018
Study completion30 Apr 2018

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 Acute Myeloid LeukemiaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01883362
Sponsor's protocol ID: CPKC412AUS23
Acronym: RADIUS
Status last verified: Mar 2021
First submitted: 25 Mar 2013
Last updated: 17 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Maziarz RT, Levis M, Patnaik MM, Scott BL, Mohan SR, Deol A, Rowley SD, Kim DDH, Hernandez D, Rajkhowa T, Haines K, Bonifacio G, Rine P, Purkayastha D, Fernandez HF. Midostaurin after allogeneic stem cell transplant in patients with FLT3-internal tandem duplication-positive acute myeloid leukemia. Bone Marrow Transplant. 2021 May;56(5):1180-1189. doi: 10.1038/s41409-020-01153-1. Epub 2020 Dec 7.
PubMed 33288862

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
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Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT01883362
Acronym / sponsor ID: RADIUS / CPKC412AUS23
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia, AML, FLT3-ITD, midostaurin, PKC412, allogeneic hematopoeitic stem cell tranplant, SCT, HSCT
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 6 Feb 2014 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 21 Jun 2013 (estimated)
Results: Posted 17 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard of Care with Midostaurin	Experimental	Drug: MidostaurinPatients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
Standard of Care	Active comparator	Other: Standard of CarePatients received standard of care alone in the post SCT setting

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients between 18 and 70 years of age
Patients with ECOG Performance Status of ≤ 2
Patients with a documented unequivocal diagnosis of AML according to WHO 2008 classification (>20% blasts in the bone marrow), excluding M3 (acute promyelocytic leukemia).
Patients with a documented FLT3 ITD mutation, determined by local laboratory for eligibility (historical tissue will be requested for central analysis confirmation)
Patients who undersent allogeneic HSCT in CR1 from a matched related or matched unrelated donor. All of the following criteria had to be met: HLA typing to include available 8/8 or 7/8 allele HLA matched donor (at A,B,C, DRB1) Single allelic mismatch allowed

Key exclusion criteria (18 listed)

Patients who failed prior attempts at allogeneic HSCT
Patients who had received an autologous transplant
Patients with Acute GVHD Grade III-IV
Patients with a known confirmed diagnosis of HIV infection or active viral hepatitis.
Impaired cardiac function including any of the following:

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
MidostaurinAlso: PKC412Midostaurin was supplied in 25mg soft gelatin capsule taken orally twice a day for 28 days of each cycle. Patients will be treated for 12 cycles.	Drug	Standard of Care with Midostaurin
Standard of CareStandard of Care was not defined per protocol. The investigator prescribed based on the commonly used medications given in the post SCT setting.	Other	Standard of Care

Primary outcome

Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis
Time frame: date of transplant up to 18 months
Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.

7 secondary outcomes

Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis
Time frame: Randomization to 18 months
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis
Time frame: date of transplant up to 24 months
Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis
Time frame: date of transplant up to 24 months
Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
Time frame: date of transplant up to 24 months
Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
Time frame: date of transplant up to 24 months
FLT3-ITD Mutation Status Centrally in Archived Material From Diagnosis (if Available) Including Mutant:Wild Type Ratio.
Time frame: up to 24 months from date of transplannt or at study completion
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Time frame: Pre-dose on days 1 and 15 of Cycle 1, on day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Results and safety

Results posted to the registry on 17 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care With Midostaurin	30	14
Standard of Care	30	16

Primary outcome: Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis

Time frame: date of transplant up to 18 months. Number (95% Confidence Interval). Unit: proportion of participants

Measure	Standard of Care With Midostaurin n = 30	Standard of Care n = 30
6 months	0.93 (0.75 to 0.98)	0.93 (0.74 to 0.98)
12 months	0.80 (0.59 to 0.91)	0.93 (0.74 to 0.98)
18 months	0.76 (0.54 to 0.88)	0.89 (0.69 to 0.96)

Standard of Care With Midostaurin vs Standard of Care: Hazard Ratio (HR): 0.46 (95% CI 0.12 to 1.86), p = 0.2655, Log Rank

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care With Midostaurin	9 of 30 (30%)	28 of 30 (93.3%)	1 of 30
Standard of Care	15 of 30 (50%)	26 of 30 (86.7%)	0 of 30
ALL Patients	24 of 60 (40%)	54 of 60 (90%)	1 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33288862Maziarz RT, Levis M, Patnaik MM, Scott BL, Mohan SR, Deol A, Rowley SD, Kim DDH, Hernandez D, Rajkhowa T, Haines K, Bonifacio G, Rine P, Purkayastha D, Fernandez HF. Midostaurin after allogeneic stem cell transplant in patients with FLT3-internal tandem duplication-positive acute myeloid leukemia. Bone Marrow Transplant. 2021 May;56(5):1180-1189. doi: 10.1038/s41409-020-01153-1. Epub 2020 Dec 7.

Related trials for Acute Myeloid Leukemia

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
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Active, not recruitingPhase 2
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RecruitingPhase 1/2
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Not yet recruitingPhase 1
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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.

Brian Elliott, MD study director

Novartis Pharmaceuticals

19 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Midostaurin in people with Acute Myeloid Leukemia, run by Novartis Pharmaceuticals at 19 sites in 2 countries.

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 8 inclusion and 18 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 17 Mar 2021). 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?

Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis (time frame: date of transplant up to 18 months). 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 NCT01883362, 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 Mar 2021.