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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002483-27 | EudraCT Number |
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PKB116611 is an open-label Phase I/II study of the investigational drug GSK2110183 given in combination with carboplatin and paclitaxel to subjects with recurrent ovarian cancer. Phase I is a dose escalation evaluation of daily oral doses of GSK2110183 administered in combination with every 3 week carboplatin and paclitaxel to any subject with recurrent ovarian cancer. Phase II is a single arm evaluation of the clinical efficacy of the combination identified in Phase I to subjects with platinum-resistant ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2110183, carboplatin and paclitaxel | Experimental | Subjects will be treated with a maximum of six doses of carboplatin + paclitaxel in combination with continuous daily GSK2110183 followed by single agent GSK2110183 at the single-agent MTD of 125 mg or above oral daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2110183 in combination with carboplatin and paclitaxel | Drug | Phase I is a dose escalation evaluation of increasing doses of GSK2110183 administered on a continuous daily schedule in combination with carboplatin AUC 5 and paclitaxel 175mg/m2 given every three weeks for a maximum 6 cycles. The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. Treatment with the three drug regimen will continue for a maximum of 6 x 21 day cycles followed by continuous GSK2110183 at the single agent MTD. Subjects may continue on study drug until progression, death or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade Greater Than or Equal to (≥) 3 in Severity | Up to Week 3 | |
| Phase 1 Safety: Number of Subjects Reporting Adverse Events | Study Treatment refers to GSK2110183 with or without Carboplatin and/or Paclitaxel. Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug & occurs within first 3 weeks of therapy & met at least one of the following criteria:
| Up to Week 3 |
| Phase 1: Maximum Tolerated Dose (MTD) of GSK2110183 | MTD is defined as the highest dose at which 1 or fewer of up to 6 subjects experience a dose limiting toxicity (DLT) during the first 3 weeks of combination therapy. MTD was considered exceeded if 2 or more subjects in a cohort of up to 6 subjects experienced a DLT. | Up to Week 3 |
| Overall Response Rate (ORR) in Phase 2 Subjects With Recurrent Platinum-resistant Ovarian Cancer (Cohort A) | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is greater than or equal to (≥) 30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. | Every 3 weeks up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR in Phase 1 Subjects With Recurrent Platinum-resistant Ovarian Cancer | Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. | Up to Week 3 |
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Phase I Inclusion Criteria:
Phase II Inclusion Criteria:
Cohort A
Cohort B
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Brigandi, MD, PhD, FAAP | GlaxoSmithKline | Study Director |
| Anne L Hamilton | Royal Women's Hospital | Principal Investigator |
| Sarah P Blagden | Imperial College Healthcare NHS Trust | Principal Investigator |
| Linda Mileshkin | Peter MacCallum Cancer Centre, Australia | Principal Investigator |
| Shirley S Wong | Western Hospital | Principal Investigator |
| Andrew Dean | Sir Charles Gairdner Hospital | Principal Investigator |
| Marcia Hall | Mount Vernon Cancer Center | Principal Investigator |
| Bhawana Awasthy, MD | Syneos Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia | ||
| Peter MacCallum Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30563934 | Derived | Blagden SP, Hamilton AL, Mileshkin L, Wong S, Michael A, Hall M, Goh JC, Lisyanskaya AS, DeSilvio M, Frangou E, Stronach EA, Gopalakrishna P, Meniawy TM, Gabra H. Phase IB Dose Escalation and Expansion Study of AKT Inhibitor Afuresertib with Carboplatin and Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer. Clin Cancer Res. 2019 Mar 1;25(5):1472-1478. doi: 10.1158/1078-0432.CCR-18-2277. Epub 2018 Dec 18. |
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As described in Statistical Analysis Plan (SAP) dated 14-Jul-2015, as there were <10 subjects in Cohort B (n=2), data was summarized in phase 2 total column but not presented in a separate column for Cohort B.
Subjects were enrolled at 10 centers in 3 countries (United Kingdom, Australia, and Russia)
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 (Dose Escalation)-Cohort 1: GSK2110183 50 mg | GSK2110183 50 mg capsule by mouth daily in combination with carboplatin Area Under the Curve (AUC) 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles. |
| FG001 | Phase 1 (Dose Escalation)-Cohort 1.5: GSK2110183 75 mg | GSK2110183 75 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles. |
| FG002 | Phase 1 (Dose Escalation)-Cohort 2: GSK2110183 100 mg | GSK2110183 100 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles. |
| FG003 | Phase 1 (Dose Escalation)-Cohort 3: GSK2110183 125 mg | GSK2110183 125 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles. |
| FG004 | Phase 1 (Dose Escalation)-Cohort 4: GSK2110183 150 mg | GSK2110183 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles. |
| FG005 | Phase 2 (Treatment Group): GSK2110183 125 mg (MTD) | The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1-Cohort 1: GSK2110183 50 mg |
| |||||||||||||
| Phase 1-Cohort 1.5: GSK2110183 75 mg |
| |||||||||||||
| Phase 1-Cohort 2: GSK2110183 100 mg |
| |||||||||||||
| Phase 1-Cohort 3: GSK2110183 125 mg |
| |||||||||||||
| Phase 1-Cohort 4: GSK2110183 150 mg |
| |||||||||||||
| Phase 2: GSK2110183 125 mg |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 (Dose Escalation): GSK2110183 | GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles. |
| BG001 | Phase 2 (Treatment Group): GSK2110183 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Phase 1: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade Greater Than or Equal to (≥) 3 in Severity | All Treated Subjects (ATS) in Phase 1. | Posted | Number | Participants | Up to Week 3 |
|
|
Up to Day 51
Included Serious Adverse Events (SAEs) and Adverse Events (AEs) for ATS population
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 | Phase 1 (Dose Escalation): GSK2110183 | GSK2110183, either at 50 mg, 75 mg, 100 mg, 125 mg or 150 mg capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharma AG | +41 613241111 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000595148 | GSK2110183 |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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|
|
| ORR in Phase 2 Subjects With Recurrent Platinum-refractory Ovarian Cancer (Cohort B) | Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. | Every 3 weeks up to 6 months |
| Phase 2: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade ≥3 in Severity | Up to Day 21 (Phase 2) |
| Phase 2 Safety: Number of Subjects Reporting Adverse Events | Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug & occurs within first 3 weeks of therapy & met at least one of the following criteria:
| Up to Day 51 |
| Phase 2: Response Rate (RR) Defined by Gynecologic Cancer Intergroup (GCIG) CA 125 | RR is defined by the percentage of subjects with investigator-assessed Partial Cancer Antigen (CA) 125 Response (PR) or Complete CA 125 Response (CR) at any time during the study by GCIG CA 125. PR is greater than (>) 50% decrease in CA-125 values from baseline and no clinical or radiological evidence of new lesions. CR is decrease in the CA-125 to within the normal limits and less than (<) 40 IU/mL and no clinical or radiological evidence of disease. | From Month 1 to 6 |
| Progression Free Survival (PFS) by RECIST or Clinical Symptomatic Progression of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A) | PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or clinical symptomatic progression or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started. | From first dose until disease progression or death (approximately 36 months) |
| PFS by RECIST of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A) | PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started. | From first dose until disease progression or death (approximately 36 months) |
| East Melbourne |
| Victoria |
| 8006 |
| Australia |
| Western Hospital | Footscray | Victoria | 3011 | Australia |
| Royal Women's Hospital | Parkville | Victoria | 3052 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Medical Radiology Scientific Center of Ministry of Healthcare and Social Development of RF | Omskaya | 249036 | Russia |
| City Clinical Oncology Dispensary | Saint Petersburg | 198255 | Russia |
| Mount Vernon Cancer Center | Northwood, Middlesex | London | HA6 2RN | United Kingdom |
| Royal Surrey County Hospital NHS Foundation Trust | Guildford | Surry | GU2 7XP | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W 12 0HS | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
|
| Primary | Phase 1 Safety: Number of Subjects Reporting Adverse Events | Study Treatment refers to GSK2110183 with or without Carboplatin and/or Paclitaxel. Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug & occurs within first 3 weeks of therapy & met at least one of the following criteria:
| ATS population (Phase 1) | Posted | Number | participants | Up to Week 3 |
|
|
|
| Primary | Phase 1: Maximum Tolerated Dose (MTD) of GSK2110183 | MTD is defined as the highest dose at which 1 or fewer of up to 6 subjects experience a dose limiting toxicity (DLT) during the first 3 weeks of combination therapy. MTD was considered exceeded if 2 or more subjects in a cohort of up to 6 subjects experienced a DLT. | ATS population (Phase 1). | Posted | Number | mg | Up to Week 3 |
|
|
|
| Primary | Overall Response Rate (ORR) in Phase 2 Subjects With Recurrent Platinum-resistant Ovarian Cancer (Cohort A) | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is greater than or equal to (≥) 30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. | ATS population (Phase 2-Cohort A) | Posted | Number | Percentage of participants | Every 3 weeks up to 6 months |
|
|
|
| Primary | ORR in Phase 2 Subjects With Recurrent Platinum-refractory Ovarian Cancer (Cohort B) | Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. | As described in SAP (dated 14-Jul-2015), data was not analyzed separately for Cohort B (n=2) as there were <10 subjects in this group due to difficulty in enrolling Platinum-refractory ovarian cancer subjects. | Posted | Every 3 weeks up to 6 months |
|
|
| Secondary | ORR in Phase 1 Subjects With Recurrent Platinum-resistant Ovarian Cancer | Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. | ATS population (Phase 1) | Posted | Number | Percentage of participants | Up to Week 3 |
|
|
|
| Secondary | Phase 2: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade ≥3 in Severity | ATS population (Phase 2) | Posted | Number | participants | Up to Day 21 (Phase 2) |
|
|
|
| Secondary | Phase 2 Safety: Number of Subjects Reporting Adverse Events | Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug & occurs within first 3 weeks of therapy & met at least one of the following criteria:
| ATS population (Phase 2) | Posted | Number | participants | Up to Day 51 |
|
|
|
| Secondary | Phase 2: Response Rate (RR) Defined by Gynecologic Cancer Intergroup (GCIG) CA 125 | RR is defined by the percentage of subjects with investigator-assessed Partial Cancer Antigen (CA) 125 Response (PR) or Complete CA 125 Response (CR) at any time during the study by GCIG CA 125. PR is greater than (>) 50% decrease in CA-125 values from baseline and no clinical or radiological evidence of new lesions. CR is decrease in the CA-125 to within the normal limits and less than (<) 40 IU/mL and no clinical or radiological evidence of disease. | ATS population (Phase 2) | Posted | Number | Percentage of participants | From Month 1 to 6 |
|
|
|
| Secondary | Progression Free Survival (PFS) by RECIST or Clinical Symptomatic Progression of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A) | PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or clinical symptomatic progression or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started. | ATS population (Phase 2-Cohort A) | Posted | Median | 95% Confidence Interval | Months | From first dose until disease progression or death (approximately 36 months) |
|
|
|
| Secondary | PFS by RECIST of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A) | PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started. | ATS population ((Phase 2-Cohort A) | Posted | Median | 95% Confidence Interval | Months | From first dose until disease progression or death (approximately 36 months) |
|
|
|
| 14 |
| 29 |
| 29 |
| 29 |
| EG001 | Phase 2 (Treatment Group): GSK2110183 | The dosing regimen identified in Phase 1 will then be evaluated in Phase 2, a single arm study focused on clinical efficacy. GSK2110183 125 mg (MTD) capsule by mouth daily in combination with carboplatin AUC 5 and paclitaxel 175 mg/m2 given intravenously every 3 weeks for a maximum 6 x 21 day cycles followed by continuous GSK2110183 150 mg capsule by mouth daily until progression, death or unacceptable toxicity. | 16 | 30 | 30 | 30 |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Colonic Obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Lip Swelling | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oesophageal Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neutropenic Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Oral Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Peritonitis Bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Respiratory Tract Infection Bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Transaminases Increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| CARDIAC DISORDERS | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| RENAL AND URINARY DISORDERS | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| EYE DISORDERS | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
Not provided
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| Title | Measurements |
|---|---|
|
| GSK2110183 Related TEAEs |
|
| Study Treatment Related TEAEs |
|
| TEAEs Leading to Discontinuation of GSK2110183 |
|
| TEAEs Leading to Discontinuation of Study Treatmnt |
|
| TEAEs Leading to Dose Modification of GSK2110183 |
|
| TEAEs Leading to Dose Modification of Study Trtmnt |
|
| TEAEs Leading to Death |
|
| Dose Limiting Toxicity |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Not Evaluable |
|
| Overall Response Rate |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Not Evaluable |
|
| Overall Response Rate |
|
| Title | Measurements |
|---|---|
|
| Diarrhoea |
|
| Rash Maculo-Papular |
|
| Vomiting |
|
| Anaemia |
|
| Rash |
|
| Fatigue |
|
| Nausea |
|
| Neutropenic sepsis |
|
| Hyperglycemia |
|
| Title | Measurements |
|---|---|
|
| GSK2110183 Related TEAEs |
|
| Study Treatment Related TEAEs |
|
| TEAEs Leading to Discontinuation of GSK2110183 |
|
| TEAEs Leading to Discontinuation of Study Treatmnt |
|
| TEAEs Leading to Dose Modification of GSK2110183 |
|
| TEAEs Leading to Dose Modification of Study Trtmnt |
|
| TEAEs Leading to Death |
|
| Dose Limiting Toxicity |
|
| Title | Measurements |
|---|---|
|
| CA 125 Progression |
|
| Not Evaluable |
|
| Response rate |
|