Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I3G-MC-JGCA | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
The pharmacokinetic properties of the molecule do not allow for further dose escalation or development.
Not provided
Not provided
Not provided
Not provided
Not provided
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The main purpose of this trial is to determine a recommended Phase 2 dose of LY2584702 that may be safely administered to participants with advanced/metastatic cancer.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2584702 | Experimental | Oral dose escalation starting at 25 milligrams (mg), daily for 28 day cycles in Part A; oral dose escalation starting at 50 mg, twice daily for 28 day cycles in Part B; oral dose with schedule determined by Parts A and B will be administered in Part C (dose confirmation). Part A: Participants received 25 mg, 50 mg, 100 mg and 200 mg once daily (QD) and 300 mg twice daily (BID) of LY2584702 capsule, for a 28-day cycle during Part A of the study until the criteria for maximum tolerated dose (MTD) were met. Part B: Participants received 50 mg, 75 mg and 100 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until the criteria for maximum tolerated dose (MTD) were met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2584702 | Drug | administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Dose for Phase 2 Studies/Maximum Tolerated Dose (MTD) | Based on the maximum tolerated dose (MTD): highest dose where <33% participants experienced a dose-limiting toxicity (DLT). DLTs were adverse events (AEs) during Cycle 1 that met any 1 of the following criteria using National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTCAE) grading: any ≥Grade 3 nonhematological toxicity (except nausea/vomiting, diarrhea or hypophosphatemia without maximal symptomatic/prophylactic treatment) that was not related to study disease, any ≥Grade 3 thrombocytopenia with bleeding, any Grade 4 hematological toxicity of >5 days duration or any febrile neutropenia. Investigators, together with the sponsor, could declare a DLT during Cycle 1 if a participant experienced increasing toxicity and it was clear that further treatment would expose the participant to excessive risk. The MTD was below the level required for efficacy, therefore, the study was terminated early and the recommended Phase 2 dose was not calculated. | Parts A and B, Baseline through Cycle 1 (1 cycle=28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, Maximum Plasma Concentration (Cmax) | Cmax results on Day 1 and on Day 8 (steady state) are reported. | Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, 8 hours postdose) |
| Number of Participants With Tumor Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-817-285-4559) or 1-317-615-4559 Mon-Fri Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Monica | California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24440085 | Derived | Tolcher A, Goldman J, Patnaik A, Papadopoulos KP, Westwood P, Kelly CS, Bumgardner W, Sams L, Geeganage S, Wang T, Capen AR, Huang J, Joseph S, Miller J, Benhadji KA, Brail LH, Rosen LS. A phase I trial of LY2584702 tosylate, a p70 S6 kinase inhibitor, in patients with advanced solid tumours. Eur J Cancer. 2014 Mar;50(5):867-75. doi: 10.1016/j.ejca.2013.11.039. Epub 2014 Jan 15. |
Not provided
Not provided
Parts A and B of the study were conducted to determine the dose and dosing schedule to be used in Part C (dose confirmation phase). The decision to initiate Part B was based on the safety, pharmacokinetic, and pharmacodynamic results in Part A. The study was terminated prior to participant enrollment in Part C of the study.
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | 25 mg LY2584702 QD | Participants received 25 milligrams (mg) of LY2584702 orally as a capsule, once daily (QD) for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| FG001 | 50 mg LY2584702 QD | Participants received 50 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| FG002 | 100 mg LY2584702 QD | Participants received 100 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| FG003 | 200 mg LY2584702 QD | Participants received 200 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| FG004 | 50 mg LY2584702 BID | Participants received 50 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| FG005 | 75 mg LY2584702 BID | Participants received 75 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| FG006 | 100 mg LY2584702 BID | Participants received 100 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| FG007 | 300 mg LY2584702 BID | Participants received 300 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 25 mg LY2584702 QD | Participants received 25 milligrams (mg) of LY2584702 orally as a capsule, once daily (QD) for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| BG001 | 50 mg LY2584702 QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recommended Dose for Phase 2 Studies/Maximum Tolerated Dose (MTD) | Based on the maximum tolerated dose (MTD): highest dose where <33% participants experienced a dose-limiting toxicity (DLT). DLTs were adverse events (AEs) during Cycle 1 that met any 1 of the following criteria using National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTCAE) grading: any ≥Grade 3 nonhematological toxicity (except nausea/vomiting, diarrhea or hypophosphatemia without maximal symptomatic/prophylactic treatment) that was not related to study disease, any ≥Grade 3 thrombocytopenia with bleeding, any Grade 4 hematological toxicity of >5 days duration or any febrile neutropenia. Investigators, together with the sponsor, could declare a DLT during Cycle 1 if a participant experienced increasing toxicity and it was clear that further treatment would expose the participant to excessive risk. The MTD was below the level required for efficacy, therefore, the study was terminated early and the recommended Phase 2 dose was not calculated. | All participants who received at least 1 dose of study drug. | Posted | Number | milligrams (mg) | Parts A and B, Baseline through Cycle 1 (1 cycle=28 days) |
Not provided
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 25 mg LY2584702 QD | Participants received 25 milligrams (mg) of LY2584702 orally as a capsule, once daily (QD) for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v11.0 | Systematic Assessment | Event resulted in death. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v11.0 | Systematic Assessment |
Part C of the study was terminated because exposure at the maximum tolerated dose (MTD) was determined to be below the level required for efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| C588151 | LY2584702 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Tumor response was defined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. Complete Response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; Partial Response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) was at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD) was small changes that did not meet above criteria including persistence of 1 or more non-target lesion(s).
| Parts A and B, Baseline through study completion [up to Cycle 10 (1 cycle=28 days)] |
| Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Once Daily (QD) LY2584702 Dosing | Results for AUC from time 0 to infinity [AUC(0-inf)] and AUC from time 0 to 24 hours [AUC(0-24)] on Day 1 and Day 8 (steady state) are reported for participants on a QD LY2584702 dosing regimen. | Part A, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose) |
| Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Twice Daily (BID) LY2584702 Dosing | Results for AUC from time 0 to infinity [AUC(0-inf)] and AUC from time 0 to 12 hours [AUC(0-12)] on Day 1 and Day 8 (steady state) are reported for participants with a BID LY2584702 dosing regimen. | Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose) |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Antonio | Texas | United States |
Participants received 50 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| BG002 | 100 mg LY2584702 QD | Participants received 100 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| BG003 | 200 mg LY2584702 QD | Participants received 200 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| BG004 | 50 mg LY2584702 BID | Participants received 50 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| BG005 | 75 mg LY2584702 BID | Participants received 75 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| BG006 | 100 mg LY2584702 BID | Participants received 100 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| BG007 | 300 mg LY2584702 BID | Participants received 300 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Part A | Participants received 25 mg, 50 mg, 100 mg and 200 mg once daily (QD) and 300 mg twice daily (BID) of LY2584702 capsule, for a 28-day cycle during Part A of the study until the criteria for maximum tolerated dose (MTD) were met. |
| OG001 | Part B | Participants received 50 mg, 75 mg and 100 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until the criteria for maximum tolerated dose (MTD) were met. |
|
|
| Secondary | Pharmacokinetics, Maximum Plasma Concentration (Cmax) | Cmax results on Day 1 and on Day 8 (steady state) are reported. | All participants who received at least 1 dose of study drug and had evaluable Cmax data. In 300 mg LY2584702 BID group data was not analyzed for Cmax day 8 due to insufficient participants at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, 8 hours postdose) |
|
|
|
| Secondary | Number of Participants With Tumor Response | Tumor response was defined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. Complete Response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; Partial Response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) was at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD) was small changes that did not meet above criteria including persistence of 1 or more non-target lesion(s). | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Parts A and B, Baseline through study completion [up to Cycle 10 (1 cycle=28 days)] |
|
|
|
| Secondary | Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Once Daily (QD) LY2584702 Dosing | Results for AUC from time 0 to infinity [AUC(0-inf)] and AUC from time 0 to 24 hours [AUC(0-24)] on Day 1 and Day 8 (steady state) are reported for participants on a QD LY2584702 dosing regimen. | All participants who received at least 1 dose of study drug [QD dosing regimen (Part A)]. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliter (ng*hr/mL) | Part A, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose) |
|
|
|
| Secondary | Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Twice Daily (BID) LY2584702 Dosing | Results for AUC from time 0 to infinity [AUC(0-inf)] and AUC from time 0 to 12 hours [AUC(0-12)] on Day 1 and Day 8 (steady state) are reported for participants with a BID LY2584702 dosing regimen. | All participants who received at least 1 dose of study drug [BID dosing regimen (Part A or B)] and had evaluable AUC data. In 300 mg LY2584702 BID group data was not analyzed for AUC(0-12) day 8 due to insufficient participants at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliter (ng*hr/mL) | Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose) |
|
|
|
| 2 |
| 3 |
| 2 |
| 3 |
| EG001 | 50 mg LY2584702 QD | Participants received 50 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 2 | 8 | 7 | 8 |
| EG002 | 100 mg LY2584702 QD | Participants received 100 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 1 | 3 | 2 | 3 |
| EG003 | 200 mg LY2584702 QD | Participants received 200 mg LY2584702 orally as a capsule, QD for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 2 | 6 | 5 | 6 |
| EG004 | 50 mg LY2584702 BID | Participants received 50 mg LY2584702 orally as a capsule, twice daily (BID) for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 1 | 3 | 3 | 3 |
| EG005 | 75 mg LY2584702 BID | Participants received 75 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 1 | 3 | 3 | 3 |
| EG006 | 100 mg LY2584702 BID | Participants received 100 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part B of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 3 | 6 | 6 | 6 |
| EG007 | 300 mg LY2584702 BID | Participants received 300 mg LY2584702 orally as a capsule, BID for a 28-day cycle during Part A of the study until disease progression, unacceptable toxicity, or other withdrawal criteria were met. | 1 | 2 | 2 | 2 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment | Event resulted in death. |
|
| Vomiting | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA v11.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA v11.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v11.0 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA v11.0 | Systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA v11.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA v11.0 | Systematic Assessment |
|
| Ocular surface disease | Eye disorders | MedDRA v11.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA v11.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v11.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA v11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Peroneal nerve palsy | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA v11.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v11.0 | Systematic Assessment |
|
Not provided
|
| Day 8 |
|
|
| Partial Response |
|
| Stable Disease |
|
| Progressive Disease |
|
|
| AUC(0-24), Day 1 |
|
|
| AUC(0-24), Day 8 |
|
|
|
| AUC(0-12), Day 1 |
|
|
| AUC(0-12), Day 8 |
|
|