A Phase 2 interventional study of Pasireotide LAR and Everolimus in Neuroendocrine Carcinoma of the Lung and Thymus, sponsored by Novartis Pharmaceuticals. Completed at 36 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-02.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus
This was a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a single-stage design in each arm. The purpose of this study was to test the effectiveness and safety of Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma (typical and atypical) of the lung and thymus. It was expected that a total of 120 patients with 40 patients in each arm were to be enrolled into this study. Patients were seen weekly for one month and monthly thereafter. Radiological and biochemical response assessments were performed every 3 months.
Patients with disease control (stable disease or better) in the combination arm or monotherapy with pasireotide LAR and everolimus who had not experienced unacceptable toxicity were permitted to continue treatment in the extension phase of the study and were seen every 3 months. Patients could remain in the extension phase as long as they continued to have clinical benefit and had not fulfilled any of the study discontinuation criteria. All patients had a safety follow-up visit 56 days after last treatment dose.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's enrollment of 124 is above the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1
Drug: Pasireotide LAR
Everolimus 10 mg taken orally (p.o) once daily starting on Day 1
Drug: Everolimus
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1
Drug: Pasireotide LAR and Everolimus Combination
60 mg was administered as an intra muscular depot injection once every 28 days starting at Day 1
Also known as: SOM230
10 mg tables administered orally once a day
Also known as: RAD001
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
Also known as: SOM230 + RAD001
Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free".
Time frame: Baseline up to 9 months
Summary of Progression-free Survival (PFS) Based on RECIST v1.1
Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1
Time frame: Baseline, every 3 months up to 69 months
Kaplan-Meier Estimates of Progression-free Survival (PFS)
Percent (%) event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1.
Time frame: Baseline, every 3 months up to 69 months
Summary of Time to Response (Months)
Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1.
Time frame: Every 3 months up to Year 1
Summary of Duration of Response (Months)
Date of first objective tumor response to date of tumor progression or death due to any cause.
Time frame: Every 3 months up to Year 1
12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
Objective response rate (ORR) was defined as the percentage of patients showing a best overall response (BOR) of CR or PR during the core study according to RECIST v1.1 criteria. The best overall response is interpreted as the best response recorded from the start of the treatment until disease progression/recurrence, death from any cause or until the patient withdraws consent, whichever is earliest. DCR was was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1.
Time frame: Baseline up to Month 12
Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels
Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline.
Time frame: Baseline up to Week 52
Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set)
Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.
Time frame: Baseline up to Month 18
Kaplan-Meier Event-free Probability Estimate Based on CgA Levels
Kaplan Meier estimates are for Duration of biochemical response (DBR) outcome measure. Events are biochemical progressions i.e. an increase of CgA levels \>= 25% compared to baseline or deaths due to any cause. Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point.
Time frame: Baseline, every 3 months up to Month 18
Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment
Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.
Time frame: Baseline up Month 24
Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are biochemical progressions, i.e., an increase of CgA levels \>= 25% compared to baseline or deaths due to any cause.
Time frame: Baseline, every 3 months up to Month 24
Biochemical Response Rate (BRR) for 5HIAA Levels
The percentages are the biochemical response rates i.e. percentage of patients showing normalization i.e. return to within normal ranges, or a decrease of \>= 50% from baseline of 5HIAA concentrations.
Time frame: Baseline up Week 52
| Milestone | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| Started | 41 | 42 | 41 |
| Entered extension phase | 12 | 14 | 15 |
| Completed | 12 | 14 | 15 |
| Not completed | 29 | 28 | 26 |
| Withdrew: Adverse event | 5 | 15 | 13 |
| Withdrew: Withdrawal by subject | 1 | 0 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Death | 1 | 5 | 2 |
| Withdrew: Diseasse progression | 18 | 7 | 8 |
| Withdrew: Protocol deviation | 2 | 0 | 0 |
| Withdrew: Pi decision - did not enter extension | 0 | 1 | 0 |
| Withdrew: Worsening of clinical condition - did not enter extension | 1 | 0 | 0 |
| Milestone | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| Started | 12 | 14 | 15 |
| Completed | 0 | 0 | 0 |
| Not completed | 12 | 14 | 15 |
| Withdrew: Adverse event | 0 | 3 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Administration problems | 3 | 2 | 3 |
| Withdrew: Disease progression | 9 | 8 | 10 |
Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free".
| percentage of participants | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| Complete response | 0 (0.0 to 8.6) | 0 (0.0 to 8.4) | 0 (0.0 to 8.6) |
| Partial response | 2.4 (0.1 to 12.9) | 2.4 (0.1 to 12.6) | 2.4 (0.1 to 12.9) |
| Stable disease | 34.1 (20.1 to 50.6) | 31.0 (17.6 to 47.1) | 48.8 (32.9 to 64.9) |
| Progression-free (PF) at Month 9 | 39.0 (24.2 to 55.5) | 33.3 (19.6 to 49.5) | 58.5 (42.1 to 73.7) |
Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1
| months | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| Summary of Progression-free Survival (PFS) Based on RECIST v1.1 | 8.51 (5.68 to 14.03) | 12.48 (5.55 to 20.21) | 16.53 (11.10 to 23.26) |
Percent (%) event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1.
| event free probability estimates | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| 3 months | 83.6 (67.1 to 92.3) | 91.2 (75.1 to 97.1) | 88.6 (72.4 to 95.5) |
| 6 months | 68.2 (49.8 to 81.1) | 63.5 (44.7 to 77.4) | 85.5 (68.6 to 93.7) |
| 9 months | 49.6 (31.9 to 65.1) | 56.9 (38.1 to 71.9) | 79.2 (61.1 to 89.5) |
| 12 months | 39.9 (23.3 to 56.0) | 50.2 (31.9 to 66.0) | 55.5 (36.4 to 71.0) |
| 15 months | 32.6 (17.2 to 49.1) | 46.8 (28.9 to 62.9) | 51.2 (32.1 to 67.5) |
| 18 months | 21.8 (9.1 to 37.8) | 38.6 (21.4 to 55.6) | 42.7 (24.2 to 60.1) |
| 21 months | 14.5 (4.7 to 29.6) | 29.4 (13.6 to 47.2) | 38.0 (20.0 to 55.9) |
| 24 months | 14.5 (4.7 to 29.6) | 19.6 (6.7 to 37.4) | 28.5 (12.5 to 46.9) |
| 27 months | 14.5 (4.7 to 29.6) | 19.6 (6.7 to 37.4) | 28.5 (12.5 to 46.9) |
| 30 months | 10.9 (2.8 to 25.2) | 9.8 (1.8 to 26.2) | 19.0 (6.3 to 36.9) |
| 33 months | 10.9 (2.8 to 25.2) | 9.8 (1.8 to 26.2) | 19.0 (6.3 to 36.9) |
| 36 months | 10.9 (2.8 to 25.2) | 9.8 (1.8 to 26.2) | 14.2 (3.7 to 31.5) |
| 39 months | 10.9 (2.8 to 25.2) | 9.8 (1.8 to 26.2) | 14.2 (3.7 to 31.5) |
| 42 months | 10.9 (2.8 to 25.2) | 9.8 (1.8 to 26.2) | 14.2 (3.7 to 31.5) |
| 45 months | 10.9 (2.8 to 25.2) | 9.8 (1.8 to 26.2) | 14.2 (3.7 to 31.5) |
| 48 months | 10.9 (2.8 to 25.2) | 9.8 (1.8 to 26.2) | 14.2 (3.7 to 31.5) |
| 51 months | 10.9 (2.8 to 25.2) | NA (NA to NA) | 14.2 (3.7 to 31.5) |
| 54 months | 10.9 (2.8 to 25.2) | NA (NA to NA) | 14.2 (3.7 to 31.5) |
| 57 months | 10.9 (2.8 to 25.2) | NA (NA to NA) | 7.1 (0.6 to 25.2) |
| 60 months | 10.9 (2.8 to 25.2) | NA (NA to NA) | 7.1 (0.6 to 25.2) |
| 63 months | 10.9 (2.8 to 25.2) | NA (NA to NA) | 7.1 (0.6 to 25.2) |
| 66 months | NA (NA to NA) | NA (NA to NA) | 7.1 (0.6 to 25.2) |
| 69 months | NA (NA to NA) | NA (NA to NA) | 7.1 (0.6 to 25.2) |
Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1.
| months | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| 25th percentile | NA | NA | NA |
| Median | NA | NA | NA |
| 75th percentile | NA | NA | NA |
Date of first objective tumor response to date of tumor progression or death due to any cause.
| months | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| 25th percentile | NA | NA | NA |
| Median | NA | NA | NA |
| 75th percentile | NA | NA | NA |
Objective response rate (ORR) was defined as the percentage of patients showing a best overall response (BOR) of CR or PR during the core study according to RECIST v1.1 criteria. The best overall response is interpreted as the best response recorded from the start of the treatment until disease progression/recurrence, death from any cause or until the patient withdraws consent, whichever is earliest. DCR was was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1.
| percentage of participants | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| Objective response (CR+PR) | 2.4 (0.1 to 12.9) | 2.4 (0.1 to 12.6) | 4.9 (0.6 to 16.5) |
| Disease control rate (CR+PR+SD) | 80.5 (65.1 to 91.2) | 73.8 (58.0 to 86.1) | 78.0 (62.4 to 89.4) |
| Complete response (CR) | 0 (0.0 to 8.6) | 0 (0.0 to 8.4) | 0 (0.0 to 8.6) |
| Partial response (PR) | 2.4 (0.1 to 12.9) | 2.4 (0.1 to 12.6) | 4.9 (0.6 to 16.5) |
| Stable disease | 78.0 (62.4 to 89.4) | 71.4 (55.4 to 84.3) | 73.2 (57.1 to 85.8) |
| Progressive disease | 14.6 (NA to NA) | 4.8 (NA to NA) | 7.3 (NA to NA) |
| Unknown | 2.4 (NA to NA) | 4.8 (NA to NA) | 0 (NA to NA) |
| Not assessed | 2.4 (NA to NA) | 16.7 (NA to NA) | 14.6 (NA to NA) |
| Discontinued before month 12 | 68.3 (NA to NA) | 64.3 (NA to NA) | 63.4 (NA to NA) |
Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline.
| percentage of participants | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| Week 12 | 20.6 (8.7 to 37.9) | 7.4 (0.9 to 24.3) | 17.1 (6.6 to 33.6) |
| Week 24 | 8.8 (1.9 to 23.7) | 7.4 (0.9 to 24.3) | 20.0 (8.4 to 36.9) |
| Week 36 | 8.8 (1.9 to 23.7) | 3.7 (0.1 to 19.0) | 11.4 (3.2 to 26.7) |
| Week 48 | 8.8 (1.9 to 23.7) | 0 (0.0 to 12.8) | 11.4 (3.2 to 26.7) |
| Week 52 | 5.9 (0.7 to 19.7) | 0 (0.0 to 12.8) | 5.7 (0.7 to 19.2) |
Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.
| months | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set) | 14.75 (0.03 to NA) | 2.00 (0.03 to NA) | 8.38 (0.03 to NA) |
Kaplan Meier estimates are for Duration of biochemical response (DBR) outcome measure. Events are biochemical progressions i.e. an increase of CgA levels \>= 25% compared to baseline or deaths due to any cause. Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point.
| event free probability estimates | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| 3 months | 75.0 (31.5 to 93.1) | 37.5 (1.1 to 80.8) | 77.8 (36.5 to 93.9) |
| 6 months | 56.3 (14.7 to 84.2) | NA (NA to NA) | 77.8 (36.5 to 93.9) |
| 9 months | 56.3 (14.7 to 84.2) | NA (NA to NA) | 44.4 (13.6 to 71.9) |
| 12 months | 56.3 (14.7 to 84.2) | NA (NA to NA) | 44.4 (13.6 to 71.9) |
| 15 months | 37.5 (5.6 to 71.7) | NA (NA to NA) | 44.4 (13.6 to 71.9) |
| 18 months | 37.5 (5.6 to 71.7) | NA (NA to NA) | 44.4 (13.6 to 71.9) |
Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.
| months | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment | 2.89 (2.79 to 5.49) | 2.86 (2.79 to 3.52) | 5.62 (3.9 to 8.31) |
Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are biochemical progressions, i.e., an increase of CgA levels \>= 25% compared to baseline or deaths due to any cause.
| event free probability estimates | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| 3 months | 43.1 (26.4 to 58.6) | 35.4 (20.0 to 51.1) | 77.1 (59.4 to 87.8) |
| 6 months | 29.5 (15.0 to 45.6) | 17.7 (7.2 to 32.0) | 44.5 (27.6 to 60.0) |
| 9 months | 18.5 (7.1 to 34.0) | 11.0 (3.2 to 24.5) | 29.7 (15.5 to 45.2) |
| 12 months | 18.5 (7.1 to 34.0) | 7.4 (1.4 to 20.0) | 26.4 (13.0 to 41.9) |
| 15 months | 18.5 (7.1 to 34.0) | NA (NA to NA) | 18.1 (6.7 to 33.8) |
| 18 months | 13.8 (4.1 to 29.4) | NA (NA to NA) | 18.1 (6.7 to 33.8) |
| 21 months | 13.8 (4.1 to 29.4) | NA (NA to NA) | 18.1 (6.7 to 33.8) |
| 24 months | NA (NA to NA) | NA (NA to NA) | 18.1 (6.7 to 33.8) |
The percentages are the biochemical response rates i.e. percentage of patients showing normalization i.e. return to within normal ranges, or a decrease of \>= 50% from baseline of 5HIAA concentrations.
| percentage of participants | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| Week 12 | 20.0 (5.7 to 43.7) | 11.1 (1.4 to 34.7) | 10.0 (1.2 to 31.7) |
| Week 24 | 5.0 (0.1 to 24.9) | 11.1 (1.4 to 34.7) | 20.0 (5.7 to 43.7) |
| Week 36 | 5.0 (0.1 to 24.9) | 11.1 (1.4 to 34.7) | 5.0 (0.1 to 24.9) |
| Week 48 | 5.0 (0.1 to 24.9) | 0 (0.0 to 18.5) | 5.0 (0.1 to 24.9) |
| Week 52 | 5.0 (0.1 to 24.9) | 0 (0.0 to 18.5) | 10.0 (1.2 to 31.7) |
Collected over Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment up to maximum duration of 316 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pasireotide LAR | 2/41 (4.9%) | 17/41 (41.5%) | 40/41 (97.6%) |
| Everolimus | 7/42 (16.7%) | 20/42 (47.6%) | 42/42 (100%) |
| Pasireotide LAR and Everolimus Combination | 3/41 (7.3%) | 16/41 (39%) | 40/41 (97.6%) |
| Event | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| PneumoniaInfections and infestations | 5/41 | 2/42 | 0/41 |
| General physical health deteriorationGeneral disorders | 3/41 | 2/42 | 0/41 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/41 | 3/42 | 1/41 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 3/41 | 1/42 | 0/41 |
| DiarrhoeaGastrointestinal disorders | 1/41 | 3/42 | 2/41 |
| PyrexiaGeneral disorders | 1/41 | 3/42 | 1/41 |
| ConstipationGastrointestinal disorders | 2/41 | 0/42 | 0/41 |
| Urinary tract infectionInfections and infestations | 2/41 | 1/42 | 0/41 |
| Spinal cord compressionNervous system disorders | 2/41 | 0/42 | 0/41 |
| SyncopeNervous system disorders | 2/41 | 0/42 | 0/41 |
| Event | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination |
|---|---|---|---|
| HyperglycaemiaMetabolism and nutrition disorders | 18/41 | 14/42 | 36/41 |
| DiarrhoeaGastrointestinal disorders | 17/41 | 21/42 | 33/41 |
| StomatitisGastrointestinal disorders | 2/41 | 26/42 | 14/41 |
| Weight decreasedInvestigations | 18/41 | 18/42 | 24/41 |
| AstheniaGeneral disorders | 11/41 | 12/42 | 16/41 |
| FatigueGeneral disorders | 6/41 | 9/42 | 16/41 |
| Decreased appetiteMetabolism and nutrition disorders | 10/41 | 16/42 | 13/41 |
| Abdominal painGastrointestinal disorders | 15/41 | 6/42 | 6/41 |
| CoughRespiratory, thoracic and mediastinal disorders | 9/41 | 12/42 | 14/41 |
| AnaemiaBlood and lymphatic system disorders | 9/41 | 14/42 | 10/41 |
| Age, Customized(participants) | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination | Total |
|---|---|---|---|---|
| 18 to <65 | 21 | 18 | 24 | 63 |
| ≥65 to 84 | 20 | 24 | 17 | 61 |
| Sex: Female, Male(Participants) | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination | Total |
|---|---|---|---|---|
| Female | 15 | 19 | 13 | 47 |
| Male | 26 | 23 | 28 | 77 |
| Race/Ethnicity, Customized(Participants) | Pasireotide LAR | Everolimus | Pasireotide LAR and Everolimus Combination | Total |
|---|---|---|---|---|
| Caucasian | 40 | 42 | 40 | 122 |
| Black | 1 | 0 | 0 | 1 |
| Asian | 0 | 0 | 1 | 1 |
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