Participants with R/R NHL, including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), or transformed NHL, will receive oral BGB-11417 until the MTD (or maximum ascending dose \[MAD\]) and the RP2D can be determined.

Participants with low tumor burden R/R CLL/SLL will receive oral BGB-11417 until the MTD (or MAD) and the RP2D can be determined.

Participants in this cohort will not be enrolled until the RP2D for Cohort B is established. Participants will be treated with the monotherapy ramp-up schedule and the RP2D established in Cohort B.

Film-coated tablets administered orally as specified in the treatment arm.

BGB-11417

Lu Zhang, M.D.

The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types.

This study will have 3 cohorts for determining a monotherapy MTD and ramp-up schedule: Cohort A, participants with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R NHL); Cohort B, participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with low tumor burden; Cohort C, participants with R/R CLL/SLL with high tumor burden.

Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Bcl-2 Inhibitor BGB-11417 in Adult Patients With Mature B-cell Malignancies

The RP2D will be decided by the sponsor and based on the safety monitoring committee recommendation considering totality of data.

All AEs, including DLT events, will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (or the Grading Scale for Hematologic Toxicity in CLL Studies as appropriate).

ORR will be assessed per disease-specific response assessment guidelines as determined by the investigator.

BeiGene

Neoplasms

Digestive System Diseases

All Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Carcinoma, Hepatocellular

Multiple Myeloma

Neoplasms, Plasma Cell

Carcinoma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Single group with 5 dose escalation for each cohort (0,5 mg/kg; 1 mg/kg; 2 mg/kg; 3 mg/kg; 5 mg/kg)

LNA-i-miR-221, IV daily infusion on days 1-4 followed by 24 days washout (1 cycle lasting 28 days)

LNA-i-miR-221

Pierfrancesco Tassone, MD

The LNA-i-miR-221 Phase I trial has been designed as a monocentric open label dose escalation study which received written approval by the Competent Authority and independent Ethics Committee (IEC). LNA-i-miR-221 will be investigated for safety and tolerability in patients, men and women age ≥18 yrs, affected by Refractory-MM and advanced solid tumors.

The LNA-i-miR-221 Phase I trial is a no-profit fully academic study on research funds and no external sponsor does exist. The study is a monocentric, open-label, phase I dose-finding to determine the safety, the maximum tolerated dose (MTD), and the recommended phase II dose of LNA-i-miR-221 (RP2D) using escalating doses; The secondary endopoints will be plasma and urinary pharmacokinetc (PK), efficacy as preliminary exploration of the antitumor activity, the disease control and the evaluation of biomonitoring activity. The study will include refractory MM and advanced solid tumors. In the last cohort, if 3 out of 3 or 5 out of 6 subjects do not experience DLT, no further dose escalation will be required and dose level 5 will be declared the MTD. At the end, further expansion will be performed to define RP2D, after a critical evaluation of trial data by SRC. LNA-i-miR-221 is a 13-mer antisense miR-221 inhibitor, which takes advantage of locked nucleic acid (LNA) technology and phosphorotioate (PS) backbone chemistry to increase affinity for miR-221 and nuclease resistance and represents a new frontier for chemically modified antisense oligonucleotides.

Participants will be assigned to 5 different cohorts, according to 5 different dose levels used. The cohorts will be defined with progressive numbers (1, 2, 3, 4, 5). Each cohort will be composed of 3 to 6 subjects. The dose level of LNA-i-miR-221 will be increased from one cohort to the next one. Independently from the assigned dose level, patients from each cohort will receive a total of 4 IV administrations as boluses. The treatment cycle will last 28 days. Each subject who will not experience any DLT (see DLT definition) will remain on the assigned dose level. In the case that MTD will be defined by the occurrence of DLT at the superior level, the MTD cohort will be considered for expansion to definitely assess the RP2D studies.

The treatment schedule (as amended and approved by AIFA on 1/15/2020) will be IV daily infusion on days 1-4 followed by 24 days washout (1 cycle lasting 28 days) with a modified 3+3 Fibonacci dose escalation design, with 5 different dose levels for each cohort (0,5 mg/kg; 1 mg/kg; 2 mg/kg; 3 mg/kg; 5 mg/kg), for safety and toxicity evaluation, MTD assessment, PK and modulatory activity investigation in refractory MM and advanced solid cancer patients. No other investigational drug and/or standard antitumor chemotherapy will be allowed during the study.

The enrolled subject will require hospitalization to ensure adequate protocol adherence.

LNA-i-miR-221will be administered inpatient setting as intravenous infusion of 30 minutes. During infusion and the following two hours post infusion, patients will be continuously monitored for vital signs. Local healthy authority guidelines must be followed with regard to further observation and monitoring, if applicable. Following the first infusion, patients will be observed for at least 120 minutes for fever, chills, or other infusion-associated symptoms. If prior infusions were well tolerated (without any signs or symptoms of infusion reactions) subsequent doses of LNA-i-miR-221 will be administered in 30 minutes with a 120 minutes observation period after infusion.

The determination of LNA-i-miR-221 in human plasma and urine will be used for the pharmacokinetic evaluation. For each enrolled subject, 2-5 ml of blood samples will be drawn for the quantification of LNA-i-miR-221 before, after 15 min and at the end of infusion at the following time points: 0.5, 1, 2, 4, 6, 12 hours on days 1 and 2. On day 3 and 4, blood samples will be drawn before and at the end of infusion at the following time points: 1, 2, 4. At 24 hours (day 5) and 48 hours (day 6) after last administration blood samples will be drawn for the quantification of LNA-i-miR-221.

Urine pharmacokinetic samples (15-20 ml) will be collected at pre-dose and 6, 12 and 24 hours period postdose on day 1 of cycle of treatment. Aliquots (15-20 ml) of 24-hour urine will also be collected at post dosing time during the cycle of treatment (day 2, 3, 4 and 5).

The vials containing lyophilized LNA-i-miR-221 must be stored at +2-8°C, while the reconstituted solution must be manipulated rapidly in a safe and secure place below 25°C, with no access for unauthorized personnel. The solution can be reconstituted immediately before administration. All adverse events will be followed with appropriate medical management until resolved. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event. For selected adverse events for which administration of the investigational drug was stopped, a rechallenge of the subject with the investigational drug may be conducted if considered both safe and ethical by the study coordinator.

All the safety data will be reviewed by an independent Safety Review Committee (SRC). Dose escalation to the next dose level will be allowed by SRC. In the last cohort, if 3 out of 3 or 5 out of 6 subjects do not experience DLT, no further dose escalation will be required and dose level 5 will be declared the MTD. At the end, further expansion will be performed to define RP2D, after a critical evaluation of trial data by SRC. At 30 (+/-1) days from the first dose of treatment, each enrolled patients will be evaluated for the end of treatment (EOT) visit in order to evaluate the efficacy and clinical benefit of LNA-i-miR-221 treatment based on RECIST V1.1 criteria. Only for patients with clinical benefit or radiological response/stable disease, the treatment will be offered until disease progression or if the patient withdraws consent. Out patients follow up will be continued every two months, until death.

Back-up blood samples will be collected for re-analysis in case of failure of the test measurement or for samples lost in transit. The samples will be appropriately stored and destroyed at study closure. Monitoring and auditing procedures defined/agreed by the External board (Sequre s.r.l. and Kilimo s.r l.) will be followed, in order to comply with GCP guidelines. This will include on-site checking of the case report forms (CRF) for completeness and clarity, cross-checking with source documents, and clarification of administrative matters.

Primary endpoints:

* To determine the safety, the maximum tolerated dose (MTD) and the RP2D of LNA-i-miR-221 using escalating doses in refractory multiple myeloma (MM) and advanced solid tumors for further investigations.
* To assess the safety and toxicity of LNA-i-miR-221

Secondary endpoints:

* PK analysis
* To preliminary explore the antitumor activity, the disease control, and the efficacy
* Biomodulatory activity A minimum/maximum number of 15/36 subjects will be enrolled in the study, according to expansion cohorts. All clinical data will be inserted on the Case Report Form (CRF) pages and all data can be extracted for the purpose of the ongoing analysis of the SRC and for statistical analysis.

monocentric, open label, phase I dose-escalation to determine the safety, the maximum tolerated dose (MTD) and the recommended phase II dose of LNA-i-miR-221 (RP2D) in a minimum/maximum number of 15/36 subjects affected by MM and advanced solid tumors. LNA-i-miR-221 will be administered IV daily infusion on days 1-4 followed by 24 days washout (1 cycle lasting 28 days) with a modified 3+3 Fibonacci dose escalation design, with 5 different dose levels for each cohort (0,5 mg/kg; 1 mg/kg; 2 mg/kg; 3 mg/kg; 5 mg/kg).

A Dose Escalation Study of LNA-i-Mir-221 for Cancer Treatment

A Dose Escalation Phase I Study of LNA-i-miR-221 for the Treatment of Refractory Multiple Myeloma and Advanced Solid Tumors

To assess the safety and toxicity of LNA-i-miR-221

The maximum tolerated dose (MTD) is the dose level below the dose level at which at least 2 out of 6 patients experience DLT.

recommended phase II dose of LNA-i-miR-221 (RP2D) using escalating doses for further evaluation

Peak Plasma Concentration of LNA-i-miR-221

plasma concentration-time profile of LNA-i-miR-221

the total body clearance of LNA-i-miR-221

Preliminary assessment of the clinical benefit and antitumoral activity of LNA-i-miR-221 based on RECIST V1.1 criteria

Associazione Italiana per la Ricerca sul Cancro

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Professor of Medical Oncology, Magna Graecia University, Catanzaro, Italy

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Kennedy Disease

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Androgens

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

GSK525762

Abiraterone

Enzalutamide

Prednisone will be administered as a concomitant medication in combination with abiraterone

GSK Clinical Trials

This study aims to evaluate the combination of GSK525762 with other agents that have been shown to be effective in the treatment of CRPC or metastatic (m)CRPC. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in combination with either abiraterone (Arm A) or enzalutamide (Arm B).

This will be a two-arm, open-label dose escalation and dose expansion cohort study.

Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer

A Phase IB Open-label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Androgen Deprivation Therapy and Other Agents in Subjects With Castrate-resistant Prostate Cancer (CRPC)

IPD for this study will be made available via the Clinical Study Data Request site.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function. Number of Participants With any AEs and SAEs collected from start of the treatment until end of the study were reported.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of Participants with AEs leading to any dose reduction or delays from start of the treatment until end of the study were reported.

Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs from start of the treatment until end of the study were reported.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function.

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to any dose reduction or delays have been presented.

Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs have been presented.

PSA50 response rate is defined as percentage of participants with a decrease of \>=50% in the PSA concentration from the Baseline PSA value determined at least 12 weeks after start of treatment and confirmed \>=4 weeks later by an additional PSA evaluation.

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. PK Population consisted of all participants from the All Treated Safety Population for whom a PK sample was obtained and analyzed.

Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.

Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.

Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis.

Disease control rate (DCR) is defined as the percentage of participants with \>=1 post-Baseline disease assessment who showed either a confirmed complete response (CR), partial response (PR) or stable disease (SD) observed at \>=24 weeks per prostate cancer working group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; where CR: disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter in the short axis; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive diseases. Confidence interval (CI) was computed using exact two sided 95% CI.

Composite response rate was defined as the percentage of participants with one of the following: a) Response based on PCWG3-modified RECIST version 1.1, b) PSA decrease of \>=50% from Baseline at Week 12 and thereafter, or c) Circulating Tumor-cell Count Conversion from unfavorable (\>=5/7.5 milliliter \[mL\]) at Baseline to favorable (\<5/7.5 mL) confirmed by a second assessment at least 4 weeks later. If a participant met at least one of the above requirements, then that participant was considered a composite responder. CI was computed using exact two sided 95% CI.

Objective response rate (ORR) is defined as the percentage of participants with a confirmed CR or PR at any time as per PCWG3-modified RECIST version 1.1; where CR: Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in the short axis and PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

CTC response rate is defined as the percentage of participants with a CTC conversion to \<5/7.5 mL blood at nadir (confirmed by a second consecutive value obtained four or more weeks later) for participants with unfavourable CTC (\>=5/7.5 mL) at Baseline. CI was computed using exact two sided 95% CI.

PSA Response Rate is defined as percentage of participants achieving \>=30% decrease from Baseline PSA after 4 weeks of study treatment. The CI was calculated using exact two sided 95% CI for the percentage of participants with Baseline PSA values who show \>=30% reduction in PSA at \>=4 weeks post-Baseline.

Time to disease progression is defined as the time from date of first dose of study treatment to date of disease progression defined as one or more of the following criteria: 1. Radiographic progression by PCWG3-modified RECIST version 1.1 for participants with measurable disease, 2. Bone progression on bone scan according to the PCGW3 criteria, 3. PSA progression according to the PCWG3 criteria accompanied by any one of the following: investigator-defined clinical progression or either of the above RECIST version 1.1 radiographic progression or bone progression.

rPFS is defined as the time from study treatment start until the first date of either disease progression or death due to any cause. The date of disease progression is defined as the earliest date of disease progression as assessed by the investigator using PCWG3-modified RECIST, version 1.1 or progression on bone scan. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Performance status assessments were based on 6-point ECOG scale (from 0 to 5), where 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work); 2=ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5=dead. Data for worst case post-Baseline is presented.

EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value.

BPI-SF is 9-item self-administered questionnaire. Pain intensity score was calculated from the four items (items 3, 4, 5 and 6) for worst pain, least pain, average pain and current pain. Worst pain in last 24 hours was rated from 0 (no pain) to 10 (pain as bad as you can imagine). Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose (latest up to Week 1 Day 1). Change from Baseline was calculated as post-Baseline visit value minus Baseline value.

GlaxoSmithKline

All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.

Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.

GSK525762 60 mg+Abiraterone 1000 mg

Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.

GSK525762 60 mg Alternate+Abiraterone 1000 mg

Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.

GSK525762 40 mg+Abiraterone 1000 mg

Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.

GSK525762 80 mg+Enzalutamide 160 mg

Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.

GSK525762 60 mg+Enzalutamide 160 mg

Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.

GSK525762 60 mg Alternate+Enzalutamide 160 mg

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

GSK Response Center

Any AEs

Any SAEs

All Treated Population consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Dose reduction

Dose delay

Number of Participants With AEs Leading to Any Dose Reduction or Delays

Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment

Modified All Treated Population comprised of all participants who received at least one dose of GSK525762 plus abiraterone/enzalutamide. Only those participants with data available at the indicated time points were analyzed.

Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50)

GSK525762:Week1 Day1,n=10,6,4,10,21,18

GSK525762:Week3 Day1,n=4,3,3,9,17,10

GSK3529246:Week1 Day1,n=10,6,4,10,21,18

GSK3529246:Week3 Day1,n=4,3,3,10,17,10

PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).

Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246

Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246

GSK525762:Week1 Day1,n=8,2,2,6,9,8

GSK525762:Week3 Day1,n=4,1,3,5,6,6

GSK3529246:Week1 Day1,n=2,1,0,5,9,10

GSK3529246:Week3 Day1,n=2,2,2,4,12,7

Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246

GSK525762:Week1 Day1,n=8,2,3,1,3,4

GSK525762:Week3 Day1,n=2,2,2,1,0,0

GSK3529246:Week1 Day1,n=8,3,3,9,20,17

GSK3529246:Week3 Day1,n=3,3,2,7,13,8

Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246

Week 1 Day 1, n=10,5,4

Week 3 Day 1, n=4,4,2

Cmax of Abiraterone

Tmax of Abiraterone

Week 1 Day 1, n=5,1,1

Week 3 Day 1, n=1,2,1

AUC(0-tau) of Abiraterone

Week 1 Day 1, n=9,2,3

Week 3 Day 1, n=2,4,1

Ctrough of Abiraterone

PK Population. Cmax could not be derived as only pre-dose samples were collected.

Cmax of Enzalutamide

PK Population. Tmax could not be derived as only pre-dose samples were collected.

Tmax of Enzalutamide

PK Population. AUC(0-tau) could not be derived as only pre-dose samples were collected.

AUC(0-tau) of Enzalutamide

Week 1 Day 1, Pre-dose, n=9,20,18

Week 3 Day 1, Pre-dose, n=9,19,13

Week 5 Day 1, Pre-dose, n=10,15,18

Week 9 Day 1, Pre-dose, n=6,6,13

Week 17 Day 1, Pre-dose, n=4,2,4

Week 25 Day 1, Pre-dose, n=2,2,2

Ctrough of Enzalutamide

Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed.

Disease Control Rate at Week 24

Composite Response Rate

Objective Response Rate

Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed. For GSK525762 40 mg+Abiraterone 1000 mg arm, there were no unfavorable values at Baseline, hence CTC response rate (change from unfavorable to favorable) could not be derived for this arm.

Circulating Tumor Cells (CTC) Response Rate

Prostate-specific Antigen (PSA) Response Rate at Week 4

Time to Disease Progression

Radiographic Progression-free Survival (rPFS)

All Treated Population. Only those participants with data available at the indicated time points were analyzed.

Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status

Week 1 Day 1,n=1,0,0,0,2,0

Week 2 Day 1,n=6,1,2,4,4,8

Week 3 Day 1,n=6,0,1,4,3,7

Week 4 Day 1,n=6,1,2,3,6,10

Week 5 Day 1,n=3,0,1,3,5,9

Week 9 Day 1,n=2,0,1,2,3,6

Week 13 Day 1,n=1,1,1,1,2,3

Week 17 Day 1,n=1,1,1,1,1,3

Week 21 Day 1,n=0,0,1,1,0,2

Week 25 Day 1,n=0,0,1,0,0,1

Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies	NCT04883957	Mature B-cell M...	BGB-11417	18 Years -	BeiGene
A Dose Escalation Study of LNA-i-Mir-221 for Cancer Treatment	NCT04811898	Multiple Myelom... Hepatocarcinoma Advanced Solid ...	LNA-i-miR-221	18 Years -	Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer	NCT03150056	Solid Tumours	GSK525762 Abiraterone Enzalutamide Prednisone	18 Years -	GlaxoSmithKline
Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies	NCT04883957	Mature B-cell M...	BGB-11417	18 Years -	BeiGene

Spots Global Cancer Trial Database for rp2d

Every month we try and update this database with for rp2d cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rp2d

Every month we try and update this database with for rp2d cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rp2d cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.