Metastatic Breast CancerPhase 1NCT00322374

Phase I Combination w/ Epirubicin

A Phase 1 study testing Ixabepilone and Epirubicin in people with Metastatic Breast Cancer, run by R-Pharm at 2 sites in 2 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breast Cancer
What is being tested?: Ixabepilone and Epirubicin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 2 sitesin 2 countries
Study dates: Aug 2006to Feb 2009
Phase: Phase 1
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women ≥18 years
Histologically or cytologically confirmed diagnosis of metastatic breast cancer
Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)

Who cannot join

Number of prior chemotherapy lines of treatment in the metastatic setting ≥2

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

France1 site

Local Institution
Toulouse, 31052

Other trials in France

Italy1 site

Local Institution
Milan, 20133

Other trials in Italy

About this study

Official title: A Phase I Study of Ixabepilone in Combination With Epirubicin in Patients With Metastatic Breast Cancer

Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Conditions: Metastatic Breast Cancer
Being tested: Ixabepilone, Epirubicin
Medical subject headings: Breast Neoplasms

What participants receive

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

IxabepiloneDrug
Also called IXEMPRA®, BMS-247550, Epothilone
Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.
EpirubicinDrug
Infusion, intravenous (IV): 75 mg/m^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².

Study groups in NCT00322374
Study group	Role	What they receive
25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin	Experimental	Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. Receives: Drug: Ixabepilone; Drug: Epirubicin
30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin	Experimental	Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. Receives: Drug: Ixabepilone; Drug: Epirubicin
35 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin	Experimental	Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days. Receives: Drug: Ixabepilone; Drug: Epirubicin

What is being measured

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

Number of Participants With a Dose Limiting Toxicity (DLT)
DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks
Measured: From Baseline to the end of Cycle 1 (Day 21)
Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)
The MTD was the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level. The RP2D was based on the MTD and the assessment of any relevant chronic toxicity. To obtain further confidence in the RP2D, a total maximum of 30 evaluable participants were enrolled at the MTD.
Measured: Day 21 of Cycle 1

Secondary outcomes (14)

Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation
AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event
Measured: Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug.
Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone
Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.
Measured: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2.
Measured: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Terminal Half-life (T-Half) of Single-dose Ixabepilone
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.
Measured: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Clearance (CLT) of Single-dose Ixabepilone
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.
Measured: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.
Measured: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Epirubicin Cmax
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.
Measured: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Epirubicin AUC(INF)
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=the area under the plasma concentration-time curve from time zero extrapolated to infinity of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.
Measured: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Epirubicin T-Half
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of epirubicin administered IV dose 75 mg/m^2, derived from plasma concentration versus time data.
Measured: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Epirubicin CLT
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.
Measured: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Epirubicin Vss
PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.
Measured: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease
Information on all tumor lesions was obtained at baseline by radiologic techniques, or if appropriate by physical examination (e.g. subcutaneous nodules). Measurable tumors were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, wherein complete response (CR) = disappearance of all target lesions; partial response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD)= ≥20% increase in the sum of the longest diameter of target lesions, and stable disease (SD) = small changes that do not meet above criteria.
Measured: From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2
Duration of Tumor Response
Defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death. CR= disappearance of all target lesions; PR= ≥30% decrease in the sum of the longest diameter of target lesions.
Measured: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.
Number Of Participants With Tumor Response by Duration of Response Category
Duration of response was defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death; PR= ≥30% decrease in the sum of the longest diameter of target lesions.
Measured: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.

Timeline

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

Aug 2006Feb 2009

First posted5 May 2006 (estimated)
Study startAug 2006
Primary completionFeb 2009
Study completionFeb 2009

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.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00322374
Sponsor's protocol ID: CA163-104
Other IDs: Eudract No: 2005-004864-22
Status last verified: Feb 2016
First submitted: 1 May 2006
Last updated: 10 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study of Ixabepilone in Combination With Epirubicin in Patients With Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT00322374
Acronym / sponsor ID: CA163-104
Conditions: Metastatic Breast Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: R-PharmIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 5 May 2006 (estimated)
Results: Posted 10 Aug 2010

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin	Experimental	Drug: Ixabepilone, Drug: EpirubicinParticipants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin	Experimental	Drug: Ixabepilone, Drug: EpirubicinParticipants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
35 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin	Experimental	Drug: Ixabepilone, Drug: EpirubicinParticipants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Women ≥18 years
Histologically or cytologically confirmed diagnosis of metastatic breast cancer
Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)

Key exclusion criteria (1 listed)

Number of prior chemotherapy lines of treatment in the metastatic setting ≥2

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
IxabepiloneAlso: IXEMPRA®, BMS-247550, EpothiloneInfusion, intravenous (IV), Cycle = 21 days. Dose escalation study.	Drug	25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin, 30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin, 35 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin
EpirubicinInfusion, intravenous (IV): 75 mg/m^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².	Drug	25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin, 30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin, 35 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin

Primary outcome

Number of Participants With a Dose Limiting Toxicity (DLT)
Time frame: From Baseline to the end of Cycle 1 (Day 21)
DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks
Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)
Time frame: Day 21 of Cycle 1
The MTD was the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level. The RP2D was based on the MTD and the assessment of any relevant chronic toxicity. To obtain further confidence in the RP2D, a total maximum of 30 evaluable participants were enrolled at the MTD.

14 secondary outcomes

Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation
Time frame: Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug.
Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone
Time frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone
Time frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Terminal Half-life (T-Half) of Single-dose Ixabepilone
Time frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Clearance (CLT) of Single-dose Ixabepilone
Time frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone
Time frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.
Epirubicin Cmax
Time frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Epirubicin AUC(INF)
Time frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Epirubicin T-Half
Time frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Epirubicin CLT
Time frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Epirubicin Vss
Time frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.
Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease
Time frame: From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2
Duration of Tumor Response
Time frame: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.
Number Of Participants With Tumor Response by Duration of Response Category
Time frame: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.

Results and safety

Results posted to the registry on 10 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2	0	0
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2	0	0
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2	0	0
All Participants	42	42

Primary outcome: Number of Participants With a Dose Limiting Toxicity (DLT)

Time frame: From Baseline to the end of Cycle 1 (Day 21). Number. Unit: Participants

Measure	Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2 n = 6	Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2 n = 6	Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2 n = 6
Participants with DLT:Grade 4 (severe) neutropenia	1	1	2
Total Participants with DLT	1	1	2
Participants without DLT	5	5	4

Population analysed: The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and was observed for ≥21 days following the first dose or the participant experienced DLT.

Primary outcome: Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)

Time frame: Day 21 of Cycle 1. Number. Unit: mg^m2

Measure	All Participants With Measurable Disease and Tumor Response n = 42
MTD	30
R2PD	30

Population analysed: The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and were observed for ≥21 days following the first dose or the participant experienced DLT.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2	8 of 30 (26.7%)	30 of 30 (100%)	Not reported
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2	1 of 6 (16.7%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ixabepilone and Epirubicin in people with Metastatic Breast Cancer, run by R-Pharm at 2 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 3 inclusion and 1 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, 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 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.

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 10 Aug 2010). 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?

Number of Participants With a Dose Limiting Toxicity (DLT) (time frame: From Baseline to the end of Cycle 1 (Day 21)). 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 NCT00322374.

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 Mar 2016.