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The primary objective of this study is to evaluate the safety of single agent idelalisib and to evaluate safety and define the maximum tolerated dose (MTD) of idelalisib in combination with chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idelalisib 150 mg | Experimental | Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks. |
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| Idelalisib + nab-paclitaxel | Experimental | Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + nab-paclitaxel. |
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| Idelalisib + mFOLFOX6 | Experimental | Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + mFOLFOX6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | Tablets administered orally twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events (AEs) with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the study drug. It also included the AEs that led to premature discontinuation of study drug. | First dose date up to last dose date (Maximum: 8 weeks) plus 30 days |
| Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post baseline time point, up to and including the date of last dose of study drug plus 30 days. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Severity grade is defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening). The percentage of participants for any post-baseline abnormal laboratory value in the Grade 1-4 category is reported. The term 'hypo' indicates less than the normal count of a parameter and 'hyper' indicates more than the normal count of a parameter. | First dose date up to last dose date (Maximum: 8 weeks) plus 30 days |
| Idelalisib in Combination With Chemotherapy: Percentage of Participants With Dose Limiting Toxicities (DLTs) | Dose limiting toxicities were defined as toxicities experienced during the first 28 days of treatment (Cycle 1) that were judged to be clinically significant and at least possibly related to study treatment. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FoxP3+ and Cluster Determinant 8+ (CD8+) Cells From Tumor Tissue Samples as a Measure of Pharmacodynamics Activity | Up to 2 years | |
| Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily | Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 hours (h) postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose |
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Key Inclusion Criteria:
The presence of metastatic pancreatic adenocarcinoma plus 1 of the following:
Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
Prior systemic chemotherapy treatment for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib single agent only)
Received one prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + mFOLFOX6 only)
Adequate organ function defined as follows:
Able to comprehend and willing to sign the written informed consent form
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 |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare Clinical Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32356383 | Background | Borazanci E, Pishvaian MJ, Nemunaitis J, Weekes C, Huang J, Rajakumaraswamy N. A Phase Ib Study of Single-Agent Idelalisib Followed by Idelalisib in Combination with Chemotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma. Oncologist. 2020 Nov;25(11):e1604-e1613. doi: 10.1634/theoncologist.2020-0321. Epub 2020 Jun 18. |
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35 participants were screened. The study was terminated. No participants were enrolled in the Idelalisib (IDL) + nab-paclitaxel or IDL + mFOLFOX [5- fluorouracil (FU), leucovorin and oxaliplatin] groups.
Participants were enrolled at study sites in the United States. The first participant was screened on 30 July 2015. The last study visit occurred on 27 April 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Idelalisib 150 mg | Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Nab-paclitaxel | Drug | 125 mg/m^2 administered intravenously on Days 1, 8 and 15 of each 28 day cycle |
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| mFOLFOX6 | Drug | mFOLFOX6 will be administered intravenously on Days 1 and 15 of each 28 day cycle. This regimen consists of levoleucovorin 200 milligram/meter per square (mg/m^2) or racemic leucovorin 400 mg/m^2, oxaliplatin 85 mg/m^2, bolus 5-fluorouracil 400 mg/m^2, and a 46 hour infusion of 5-fluorouracil 2, 400 mg/m^2. |
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| Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily | Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 h postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose |
| Overall Response Rate (ORR) | Overall response rate (ORR) was defined as the percentage of participants who achieved a Complete Response (CR) or Partial Response (PR) as assessed by response evaluation criteria in sold tumors (RECIST) v1.1. | Up to 2 years |
| Overall Survival (OS) | Overall survival is defined as the interval from first dose date of study drug to death from any cause. | Up to 2 years |
| Progression Free Survival (PFS) | Progression free survival is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause. | Up to 2 years |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Indiana University Goshen Center for Cancer Care | Goshen | Indiana | 46506 | United States |
| Dana Farber/ Harvard Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Mary Crowley Medical Research Center | Dallas | Texas | 75230 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The Full Analysis Set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Idelalisib 150 mg | Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | No |
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| Race/Ethnicity, Customized | Not Permitted means local regulators did not allow collection of race information. | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Not Permitted means local regulators did not allow collection of ethnicity information. | Count of Participants | Participants | No |
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| 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 | Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events (AEs) with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the study drug. It also included the AEs that led to premature discontinuation of study drug. | The Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | First dose date up to last dose date (Maximum: 8 weeks) plus 30 days |
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| Primary | Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post baseline time point, up to and including the date of last dose of study drug plus 30 days. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Severity grade is defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening). The percentage of participants for any post-baseline abnormal laboratory value in the Grade 1-4 category is reported. The term 'hypo' indicates less than the normal count of a parameter and 'hyper' indicates more than the normal count of a parameter. | Participants in the safety analysis set were analysed. | Posted | Number | percentage of participants | First dose date up to last dose date (Maximum: 8 weeks) plus 30 days |
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| Primary | Idelalisib in Combination With Chemotherapy: Percentage of Participants With Dose Limiting Toxicities (DLTs) | Dose limiting toxicities were defined as toxicities experienced during the first 28 days of treatment (Cycle 1) that were judged to be clinically significant and at least possibly related to study treatment. | Due to the early termination of the study, there were no participants enrolled in the Idelalisib Combination arms. | Posted | Up to 28 days |
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| Secondary | Change From Baseline in FoxP3+ and Cluster Determinant 8+ (CD8+) Cells From Tumor Tissue Samples as a Measure of Pharmacodynamics Activity | Due to the early termination of the study no pharmacodynamic testing was performed. | Posted | Up to 2 years |
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| Secondary | Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily | The pharmacokinetic (PK) Analysis Set included all participants in the Full Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest. Due to the early termination of the study, concentration data is reported because there was an insufficient number of participants sampled for PK analysis to generate PK parameters. | Posted | Median | Inter-Quartile Range | ng/mL | Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 hours (h) postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose |
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| Secondary | Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily | Participants in the PK Analysis Set with available data were analysed. Due to the early termination of the study, concentration data is reported because there was an insufficient number of participants sampled for PK analysis to generate PK parameters. | Posted | Median | Inter-Quartile Range | ng/mL | Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 h postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose |
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| Secondary | Overall Response Rate (ORR) | Overall response rate (ORR) was defined as the percentage of participants who achieved a Complete Response (CR) or Partial Response (PR) as assessed by response evaluation criteria in sold tumors (RECIST) v1.1. | Due to early study termination, the prespecified efficacy analyses were not conducted. | Posted | Up to 2 years |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the interval from first dose date of study drug to death from any cause. | Due to early study termination, the prespecified efficacy analyses were not conducted. | Posted | Up to 2 years |
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| Secondary | Progression Free Survival (PFS) | Progression free survival is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause. | Due to early study termination, the prespecified efficacy analyses were not conducted. | Posted | Up to 2 years |
|
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Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Idelalisib 150 mg | Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks. | 2 | 12 | 3 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Rectal spasm | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Xerosis | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
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Due to the early termination of the study, the prespecified efficacy, pharmacodynamic, and pharmacokinetic analysis for PK parameters were not conducted.
After conclusion of the study and without prior written approval from Gilead, 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 | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C552946 | idelalisib |
| C520255 | 130-nm albumin-bound paclitaxel |
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| Black |
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| Native Hawaiian or Pacific Islander |
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| White |
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| Other |
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| Not Permitted |
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| Not Permitted |
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| Participants |
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| Participants |
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