Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004480-20 | EudraCT Number |
Not provided
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There will be two phases to this study. The lead-in phase will evaluate the safety, pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with nab-paclitaxel and gemcitabine (nab-P + G) in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. The randomized treatment phase will evaluate the efficacy, safety, and tolerability of nab-P + G with either MMB administered at the MTD or placebo in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. Participants will continue study treatment until disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of treatment. Following treatment, participants will be followed for safety for 30 days and for survival approximately every 3 months for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Momelotinib | Experimental | Participants will receive momelotinib plus nab-paclitaxel and gemcitabine. |
|
| Placebo | Placebo Comparator | Participants will receive placebo to match momelotinib plus nab-paclitaxel and gemcitabine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Momelotinib | Drug | Tablet (s) administered orally once or twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events | Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment. No statistical analysis was planned or performed for this endpoint. | Up to 28 Days |
| Randomized Treatment Phase: Overall Survival (OS) | Overall survival was defined as the time interval from first dose date of MMB to death from any cause | Baseline up to the Date of Death or Censoring, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lead-In Phase: Overall Survival (OS) | Overall survival was defined as the time interval from first dose date of MMB to death from any cause | Baseline up to the Date of Death or Censoring, up to 3 years |
| Lead-In Phase: Progression-Free Survival (PFS) |
Not provided
Key Inclusion Criteria:
Presence of metastatic pancreatic adenocarcinoma plus 1 of the following:
Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin in conjunction with either:
Measurable disease per RECIST v1.1
Adequate organ function defined as follows:
Eastern Cooperative Oncology Group (ECOG ) 0 or 1
Modified Glasgow prognostic score (mGPS) of 1 or 2 at Screening (randomized phase only)
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Indiana University Health Goshen Center for Cancer Care |
38 participants were screened.
Data submitted represent analysis performed on data collected in the lead-in phase by the Study Termination Date, 10 April 2017. The study was discontinued before initiation of the randomized treatment phase, therefore no data were collected for the randomized treatment phase.
Participants were enrolled at study sites in the United States (US). The first participant was screened on 02 June 2014. The last study visit occurred on 10 April 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | MMB Dose Level 1 | Momelotinib (MMB) 100 mg tablet once daily + albumin-bound (nab)-paclitaxel plus gemcitabine (nab-P+G) (1000+1000 mg/m^2) intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle |
| FG001 | MMB Dose Level 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Feb 11, 2014 | May 30, 2018 |
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| Placebo to match momelotinib | Drug | Placebo to match momelotinib tablets administered orally once or twice daily |
|
| Nab-paclitaxel | Drug | Intravenously administered over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle |
|
| Gemcitabine | Drug | Intravenously administered over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle |
|
Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression is progression based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1. Data from survival, non-progressing participants will be censored at the earliest of the time of initiation of anti-tumor therapy other than the study treatment or the last time that lack of definitive disease progression was objectively documented while on study.
| Baseline up to the Date of Event or Censoring, up to 3 years |
| Lead-In Phase: Overall Response Rate (ORR) | The ORR was defined as the proportion of participants who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) as assessed by RECIST v1.1. | Baseline up to the Last Tumor Assessment Date, up to 3 years |
| Randomized Treatment Phase: Progression-Free Survival (PFS) | Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause | Baseline up to the Date of Event or Censoring, up to 3 years |
| Randomized Treatment Phase: Overall Response Rate | The ORR was defined as the proportion of subjects who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) | Baseline up to the Last Tumor Assessment Date, up to 3 years |
| Goshen |
| Indiana |
| 46506 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| FG002 | MMB Dose Level 3 | MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| FG003 | MMB Dose Level 4 | MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| FG004 | MMB Dose Level 5 | MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Enrolled Analysis Set: all participants who received a study participant identification number in the study after screening.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MMB Dose Level 1 | MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| BG001 | MMB Dose Level 2 | MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| BG002 | MMB Dose Level 3 | MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| BG003 | MMB Dose Level 4 | MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| BG004 | MMB Dose Level 5 | MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events | Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment. No statistical analysis was planned or performed for this endpoint. | DLT-Evaluable Analysis Set: participants in the Safety Analysis Set who completed all treatment and safety procedures through Day 28, inclusive, or experienced a DLT prior to Day 29. Participants in the DLT-Evaluable Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Up to 28 Days |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Randomized Treatment Phase: Overall Survival (OS) | Overall survival was defined as the time interval from first dose date of MMB to death from any cause | The study was discontinued before initiation of the randomized treatment phase. | Posted | Baseline up to the Date of Death or Censoring, up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lead-In Phase: Overall Survival (OS) | Overall survival was defined as the time interval from first dose date of MMB to death from any cause | All Enrolled Analysis Set | Posted | Median | Inter-Quartile Range | Months | Baseline up to the Date of Death or Censoring, up to 3 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Lead-In Phase: Progression-Free Survival (PFS) | Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression is progression based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1. Data from survival, non-progressing participants will be censored at the earliest of the time of initiation of anti-tumor therapy other than the study treatment or the last time that lack of definitive disease progression was objectively documented while on study. | All Enrolled Analysis Set | Posted | Median | Inter-Quartile Range | Months | Baseline up to the Date of Event or Censoring, up to 3 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Lead-In Phase: Overall Response Rate (ORR) | The ORR was defined as the proportion of participants who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) as assessed by RECIST v1.1. | All Enrolled Analysis Set | Posted | Count of Participants | Participants | Baseline up to the Last Tumor Assessment Date, up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Randomized Treatment Phase: Progression-Free Survival (PFS) | Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause | The study was discontinued before initiation of the randomized treatment phase. | Posted | Baseline up to the Date of Event or Censoring, up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Randomized Treatment Phase: Overall Response Rate | The ORR was defined as the proportion of subjects who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) | The study was discontinued before initiation of the randomized treatment phase. | Posted | Baseline up to the Last Tumor Assessment Date, up to 3 years |
|
Baseline up to the last dose date plus 30 days (maximum exposure= 63.7 weeks)
Safety Analysis Set: all participants who were randomized and received at least 1 dose of 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 | MMB Dose Level 1 | MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle | 4 | 7 | 4 | 7 | 7 | 7 |
| EG001 | MMB Dose Level 2 | MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle | 3 | 4 | 3 | 7 | 4 | 4 |
| EG002 | MMB Dose Level 3 | MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle | 6 | 7 | 5 | 7 | 7 | 7 |
| EG003 | MMB Dose Level 4 | MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle | 0 | 3 | 2 | 3 | 3 | 3 |
| EG004 | MMB Dose Level 5 | MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle | 3 | 4 | 4 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intracardiac mass | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancreatic failure | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness exertional | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nail bed disorder | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Sierra Oncology, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_005.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Mar 14, 2014 | May 30, 2018 | Prot_006.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Aug 25, 2014 | May 30, 2018 | Prot_007.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | Jul 16, 2015 | May 30, 2018 | Prot_008.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2017 | May 30, 2018 | SAP_009.pdf |
| ID | Term |
|---|---|
| C546012 | N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| White |
|
| Other |
|
| Not Hispanic or Latino |
|
| OG004 |
| MMB Dose Level 5 |
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
|
| OG004 |
| MMB Dose Level 5 |
MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
|
|
| OG003 | MMB Dose Level 4 | MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| OG004 | MMB Dose Level 5 | MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
|
|
| OG004 | MMB Dose Level 5 | MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
|
|
| OG004 | MMB Dose Level 5 | MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
|
| OG004 | MMB Dose Level 5 | MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle |
|