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This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b | Experimental | In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 will be explored and will follow a 6+3 dose de-escalation design and will include a sentinel participant which will have a 3-day observation period prior to dosing of subsequent participants. Participants with one of the following three tumor types will be eligible for enrollment: NSCLC (adenocarcinoma and squamous-cell carcinoma), Breast cancer (triple-negative and HER2-positive cancer), and Pancreatic cancer (adenocarcinoma). |
|
| Phase 2 | Experimental | Participants with one of three solid tumor types (Stage III/IV) will be enrolled in the Phase 2 portion of this protocol: NSCLC (adenocarcinoma and squamous-cell carcinoma), Breast cancer (triple-negative and HER2-positive cancer), and Pancreatic cancer (adenocarcinoma) and treated at the R2PD of ibrutinib and durvalumab determined in Phase 1b. An interim analysis will be performed to evaluate the response and the safety profile, and the study may be discontinued based on the interim efficacy and/or safety results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | BTK Inhibitor |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Durvalumab (MEDI4736) and to Find the Recommended Phase II Dose. | From the date of first study treatment until DLT or disease progression per RECIST 1.1. | |
| Phase 2: Efficacy of Ibrutinib in Combination With Durvalumab (MEDI4736) in Participants With Relapsed or Refractory Solid Tumors by Assessing the ORR Per RECIST 1.1. | From the date of first study treatment until progressive disease per RECIST 1.1 or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b/2: Pharmacokinetics (Cmax) of Ibrutinib | Cmax = the peak (maximum) plasma concentration of ibrutinib during the dosing interval on Cycle 3 Day 1. | 0hr, 1hr, 2hr, and 4hr post-dose |
| Phase 1b/2: Pharmacokinetics (AUC0-24h) of Ibrutinib |
Not provided
Inclusion Criteria:
Pathologically confirmed: Non-small cell lung cancer (NSCLC, adenocarcinoma or squamous-cell carcinoma), Breast Cancer (HER2 positive or triple negative), Pancreatic Cancer (adenocarcinoma)
Relapsed or refractory disease (Stage III or IV): NSCLC or pancreatic cancer must have failed at least 1 prior treatment. Breast cancer must have failed at least 2 prior treatments.
Measurable lesion by RECIST 1.1
Adequate hematologic function:
Adequate hepatic and renal function:
PT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULN
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaiah Dimery | Pharmacyclics LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b | In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 will be explored and will follow a 6 + 3 dose de-escalation design and will include a sentinel participant which will have a 3-day observation period prior to dosing of subsequent participants. Participants with one of the following three tumor types will be eligible for enrollment: NSCLC (adenocarcinoma and squamous-cell carcinoma), breast cancer (triple-negative and HER2-positive cancer), and Pancreatic cancer (adenocarcinoma). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2017 | Aug 17, 2018 |
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| Durvalumab | Drug | Anti PDL-1 |
|
|
AUC0-24 = the area under the plasma concentration-time curve of ibrutinib during the dosing interval on Cycle 3 Day 1
| 0hr, 1hr, 2hr, and 4hr post-dose |
| Phase 1b/2: Pharmacokinetics (Cmax) of Durvalumab (MEDI4736) | Cmax = the peak (maximum) plasma concentration of durvalumab (MEDI4736) after administration on Cycle 6 Day 1. | 60 minutes post-dose (dose administered as an infusion over a 1 hour period) |
| Phase 1b/2: Pharmacokinetics (Ctrough) of Durvalumab (MEDI4736) | Ctrough = the trough plasma concentration of durvalumab (MEDI4736) after administration on Cycle 6 Day 1 | Pre-dose |
| Phase 1b: Pharmacodynamics | BTK occupancy | From the date of first study treatment until DLT or disease progression per RECIST 1.1. |
| Phase 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Durvalumab (MEDI4736) | From the date of first study treatment until DLT or disease progression per RECIST 1.1. |
| Phase 2: Pharmacodynamics | BTK binding site occupancy of ibrutinib was measured from peripheral blood samples collected from participants during Cycle 3 Day 1. | Pre-dose |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| La Jolla | California | 92093 | United States |
| Los Angeles | California | 90025 | United States |
| Los Angeles | California | 90048 | United States |
| Palo Alto | California | 94305 | United States |
| San Francisco | California | 94115 | United States |
| Gainesville | Florida | 32610 | United States |
| Orlando | Florida | 32806 | United States |
| Chicago | Illinois | 60637 | United States |
| Peoria | Illinois | 61615 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Durham | North Carolina | 27710 | United States |
| Germantown | Tennessee | 38120 | United States |
| Nashville | Tennessee | 37212 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78229 | United States |
| FG001 | Phase 2 | Participants with one of three solid tumor types (Stage III/IV) will be enrolled in the Phase 2 portion of this protocol: NSCLC (adenocarcinoma and squamous-cell carcinoma), breast cancer (triple-negative and HER2-positive cancer), and pancreatic cancer (adenocarcinoma) and treated at the R2PD of ibrutinib and durvalumab determined in Phase 1b. An interim analysis will be performed to evaluate the response and the safety profile, and the study may be discontinued based on the interim efficacy and/or safety results. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
|
Baseline analysis population includes all patients that received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b/2 | All participants who received at least one dose of study treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | 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 | Phase 1b: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Durvalumab (MEDI4736) and to Find the Recommended Phase II Dose. | Posted | Number | participants | From the date of first study treatment until DLT or disease progression per RECIST 1.1. |
|
|
| ||||||||||||||||||||||||||||
| Primary | Phase 2: Efficacy of Ibrutinib in Combination With Durvalumab (MEDI4736) in Participants With Relapsed or Refractory Solid Tumors by Assessing the ORR Per RECIST 1.1. | The Response-evaluable population was participants who received at least 1 dose of treatment (ibrutinib and durvalumab) and provided 1 post-baseline response assessment. | Posted | Count of Participants | Participants | From the date of first study treatment until progressive disease per RECIST 1.1 or unacceptable toxicity. |
|
| ||||||||||||||||||||||||||||
| Secondary | Phase 1b/2: Pharmacokinetics (Cmax) of Ibrutinib | Cmax = the peak (maximum) plasma concentration of ibrutinib during the dosing interval on Cycle 3 Day 1. | All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data. Data were analyzed together for Phase 1b and Phase 2 because the dose was the same. | Posted | Mean | Standard Deviation | ng/mL | 0hr, 1hr, 2hr, and 4hr post-dose |
|
| ||||||||||||||||||||||||||
| Secondary | Phase 1b/2: Pharmacokinetics (AUC0-24h) of Ibrutinib | AUC0-24 = the area under the plasma concentration-time curve of ibrutinib during the dosing interval on Cycle 3 Day 1 | All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data. Data were analyzed together for Phase 1b/2 because the dose was the same. | Posted | Mean | Standard Deviation | h.ng/mL | 0hr, 1hr, 2hr, and 4hr post-dose |
|
| ||||||||||||||||||||||||||
| Secondary | Phase 1b/2: Pharmacokinetics (Cmax) of Durvalumab (MEDI4736) | Cmax = the peak (maximum) plasma concentration of durvalumab (MEDI4736) after administration on Cycle 6 Day 1. | All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 60 minutes post-dose (dose administered as an infusion over a 1 hour period) |
|
| ||||||||||||||||||||||||||
| Secondary | Phase 1b/2: Pharmacokinetics (Ctrough) of Durvalumab (MEDI4736) | Ctrough = the trough plasma concentration of durvalumab (MEDI4736) after administration on Cycle 6 Day 1 | All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Pre-dose |
|
| ||||||||||||||||||||||||||
| Secondary | Phase 1b: Pharmacodynamics | BTK occupancy | Data not collected | Posted | From the date of first study treatment until DLT or disease progression per RECIST 1.1. |
|
| |||||||||||||||||||||||||||||
| Secondary | Phase 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Durvalumab (MEDI4736) | Participants who enrolled and received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the date of first study treatment until DLT or disease progression per RECIST 1.1. |
|
| ||||||||||||||||||||||||||||
| Secondary | Phase 2: Pharmacodynamics | BTK binding site occupancy of ibrutinib was measured from peripheral blood samples collected from participants during Cycle 3 Day 1. | All subjects who received at least one dose of ibrutinib and who had at least one evaluable BTK occupancy assay result at Cycle 3 Day 1. | Posted | Mean | Standard Error | percentage of BTK binding site occupancy | Pre-dose |
|
|
2 years, 5 months
Adverse events were not collected by phase (Arm) because the treatments between Phase 1b and Phase 2 were not appreciably different.
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 1b/2 | All subjects who received at least one dose of study treatment. | 96 | 122 | 77 | 122 | 122 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Serratia bacteraemia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Stenotrophomonas sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increase | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thorsten Graef | Pharmacyclics LLC, An AbbVie Company | (408) 215-3127 | tgraef@pcyc.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 18, 2015 | Oct 1, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
| C000613593 | durvalumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Study Terminated by Sponsor |
|
| Other varied reasons |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|