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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03150056




Registration number
NCT03150056
Ethics application status
Date submitted
9/05/2017
Date registered
11/05/2017
Date last updated
9/04/2020

Titles & IDs
Public title
Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy and Other Agents in Subjects With Castrate-resistant Prostate Cancer
Scientific title
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)
Secondary ID [1] 0 0
2016-003416-13
Secondary ID [2] 0 0
204697
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumours 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK525762
Treatment: Drugs - Abiraterone
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Prednisone

Experimental: GSK525762 + abiraterone (Arm A) - Eligible subjects will receive treatment with GSK525762 in combination with abiraterone. Subjects will be abiraterone-refractory or resistant from L2 and Lx lines of therapy. Two dose combinations, 60 mg or 80 mg of GSK525762 will be administered once daily. There is also a possibility of dose reduction to 40 mg in case of toxicity. Dosing will continue until unacceptable toxicity, progression of disease, withdrawal of consent, death, or completion of study. Subjects may also receive prednisone in combination with abiraterone dosing.

Experimental: GSK525762 + Enzalutamide (Arm B) - Eligible subjects will receive treatment with GSK525762 in combination with enzalutamide. Subjects will be enzalutamide -refractory or resistant from L2 and Lx lines of therapy. Two to three dose combinations 80 mg, 100 mg and 120 mg of GSK525762 will be administered once daily based on the emerging data from the dose escalation part. There is also a possibility of dose reduction to 60 mg in case of toxicity. Dosing will continue until unacceptable toxicity, progression of disease, withdrawal of consent, death, or completion of study.


Treatment: Drugs: GSK525762
GSK525762 will be available as 5 milligram (mg) and 25 mg white to slightly colored, round, biconvex with no markings, film-coated tablet and will be administered with 240 milliliter (mL) water. The 20 mg tablet formulation is in development and will be used when available.

Treatment: Drugs: Abiraterone
Abiraterone will be available as 250 mg white to off-white, oval tablets debossed with AA250 on one side. It will be administered with 240 mL water.

Treatment: Drugs: Enzalutamide
Enzalutamide will be available as 40 mg white to off-white oblong soft gelatin capsules imprinted in black ink with ENZ. It will be administered with 240 mL water.

Treatment: Drugs: Prednisone
5 mg prednisone will be administered as a concomitant medication in combination with abiraterone

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events (AE) and serious adverse events (SAE) - Any AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.
Timepoint [1] 0 0
Approximately up to 3 years
Primary outcome [2] 0 0
Number of subjects with dose reductions or delays - Dose reductions or delays will be evaluated during the treatment period.
Timepoint [2] 0 0
Approximately up to 3 years
Primary outcome [3] 0 0
Number of subjects withdrawn due to toxicity - Withdrawals will be collected during the study period until the end of study.
Timepoint [3] 0 0
Approximately up to 3 years
Primary outcome [4] 0 0
Number of subjects with abnormality in laboratory parameters - Laboratory parameters includes clinical chemistry, hematology parameters, liver function tests, routine urinalysis and cardiac studies
Timepoint [4] 0 0
Approximately up to 3 years
Primary outcome [5] 0 0
Number of subjects with abnormality in vital signs - Vital signs to be measured in semi-supine position after 5 minutes rest will include temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate.
Timepoint [5] 0 0
Approximately up to 3 years
Primary outcome [6] 0 0
Number of subjects with abnormality in electrocardiogram (ECG) - Triplicate 12-lead ECGs will be obtained, prior to dosing at specific time periods
Timepoint [6] 0 0
Approximately up to 3 years
Primary outcome [7] 0 0
Number of subjects with abnormality in any cardiotoxicity parameters - Echocardiography (ECHO) or multigated acquisition (MUGA) scan will be performed to assess cardiotoxicity
Timepoint [7] 0 0
Approximately up to 3 years
Primary outcome [8] 0 0
Number of subjects with abnormality in gastrointestinal parameters - Gastrointestinal effects will be assessed during the treatment period.
Timepoint [8] 0 0
Approximately up to 3 years
Primary outcome [9] 0 0
Percentage of subjects with Prostate Specific Antigen 50 (PSA50) - PSA50 is =50% decrease in PSA from baseline. It will be analyzed after 12 weeks of treatment
Timepoint [9] 0 0
At 12 weeks and there after (assessed up to maximum of 3 years)
Secondary outcome [1] 0 0
Plasma concentration of GSK525762 and selected metabolites - Concentration of GSK525762 will be determined following repeat-dose oral administration in combination with abiraterone or enzalutamide
Timepoint [1] 0 0
Day 1 of Week (W) 1 and W3 (Pre-dose, 30 minutes (m)±5m, 1h±10m, 3h±30m, 6 to 12 hours (h) and 24 h±2h prior to dosing); Day 1 of W5 (pre-dose, 0.5-1h post-dose, [optional] 4-12h post-dose); and every 8W from W9 to W49 (pre-dose and 0.5-1 h post-dose)
Secondary outcome [2] 0 0
Plasma concentration of abiraterone or enzalutamide - Concentration of abiraterone or enzalutamide will be determined following repeat-dose oral administration in combination with GSK525762
Timepoint [2] 0 0
Day 1 of Week (W) 1 and W3 (Pre-dose, 30 minutes (m)±5m, 1h±10m, 3h±30m, 6 to 12 hours (h) and 24 h±2h prior to dosing); Day 1 of W5 (pre-dose, 0.5-1h post-dose, [optional] 4-12h post-dose); and every 8W from W9 to W49 (pre-dose and 0.5-1 h post-dose)
Secondary outcome [3] 0 0
Overall response rate (ORR) based on Prostate Cancer Working Group (PCWG3)-modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 - The overall response rate is defined as complete response (CR) plus partial response (PR)
Timepoint [3] 0 0
Approximately up to 3 years
Secondary outcome [4] 0 0
Circulating Tumor Cell (CTC) response - CTC response rate is defined as reduction from =5 cells/7.5 milliliter (mL) blood to =5 cells/7.5 mL blood
Timepoint [4] 0 0
Approximately up to 3 years
Secondary outcome [5] 0 0
Percentage of subjects with PSA response at Week 4 - PSA response is defined as percent of subjects achieving =30% decrease from baseline PSA at 4 weeks
Timepoint [5] 0 0
Week 4
Secondary outcome [6] 0 0
Time to disease progression - Time to disease progression will be evaluated either by PCWG3-modified RECIST 1.1, PSA progression, and/or progression in bone
Timepoint [6] 0 0
Approximately up to 3 years
Secondary outcome [7] 0 0
Radiographic Progression-free survival (rPFS) based on PCWG3-modified RECIST 1.1 - rPFS is defined as the time from study treatment start until the first date of either disease progression or death due to any cause
Timepoint [7] 0 0
Approximately up to 3 years
Secondary outcome [8] 0 0
Composite Response Rate defined as any one of the following: a) Response based on PCWG3-modified RECIST1.1, b) PSA decrease of =50% at Week 12 and thereafter, or c) Circulating Tumor-cell Count Conversion - CRR will be assessed.
Timepoint [8] 0 0
Approximately up to 3 years
Secondary outcome [9] 0 0
The performance status as measured by Eastern Cooperative Oncology Group (ECOG) scale - Performance status assessments are based on 5-point ECOG scale where 0 is fully active, able to carry on all pre-disease performance without restriction. 1 is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. 2 is ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50 percent of waking hrs. 3 is capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. 4 is completely disabled; cannot carry on any selfcare; totally confined to bed or chair. 5 is dead.
Timepoint [9] 0 0
Approximately up to 3 years
Secondary outcome [10] 0 0
The change in the quality of life as measured by European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) - EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small. A change of 10 - 20 points is considered a moderate change.
Timepoint [10] 0 0
Approximately up to 3 years
Secondary outcome [11] 0 0
Pain as assessed with The Brief Pain Inventory-Short Form (BPI-SF) - BPI-SF questionnaire is used to assess how pain interferes with patient's functioning in addition to measuring the intensity and location of pain.
Timepoint [11] 0 0
Approximately up to 3 years

Eligibility
Key inclusion criteria
Inclusion Criteria

- Written informed consent provided

- Males >=18 years of age (at the time written consent is obtained for screening)

- Histologically confirmed adenocarcinoma of the prostate: screening and on-treatment
biopsy is mandatory. If adequate number of paired biopsy samples are collected (>=20
paired samples for each dose level in each Arm, unless an Arm is closed early), then
further biopsy sampling will be considered based on available data; screening biopsy
can be waived if patient had a recent biopsy after failure of ADT therapy (within 30
days) and the biopsy sample is secured to be sent as screening biopsy for this study.

- Surgically or medically castrated, with testosterone levels of <=50 nanograms per
deciliter (ng/dL) (<2.0 nanometer [nM]). If the patient is being treated with
luteinizing hormone-releasing hormone (LHRH) agonists/antagonists (patient who have
not undergone orchiectomy) this therapy must have been initiated at least 4 weeks
prior to Cycle 1 Day 1 and must be continued throughout the study.

- Subjects must have failed prior therapy with abiraterone, enzalutamide, or both: has
completed at least 12 weeks of prior continuous therapy with abiraterone or
enzalutamide; has not been without abiraterone or enzalutamide treatment for >30 days
prior to initiation of study treatment; lead-in dosing period for enzalutamide only
will be required under the following circumstance:

1. If the subject has enzalutamide discontinuation for >7 days prior to dosing start
with GSK525762 plus enzalutamide on trial, then a enzalutamide only lead-in
dosing of 28 days is required

2. If the subject has enzalutamide discontinuation for <=7 days prior to dosing
start with GSK525762 plus enzalutamide on trial, then a enzalutamide only lead-in
dosing of 14 days is required

3. If the subject is on continuous dosing with enzalutamide prior to dosing start
with GSK525762 plus enzalutamide on trial, then subject can start on combined
dosing at end of screening period; Lead-in dosing period for abiraterone only
will be required: if the subject has abiraterone discontinuation for more than 3
days prior to dosing start with GSK525762 plus abiraterone on trial, then
abiraterone only lead-in dosing of 7 days is required.

- One to two line(s) of prior taxane-based chemotherapy allowed. If docetaxel
chemotherapy is used more than once, this will be considered as one regimen.

- Documented prostate cancer progression as assessed by the investigator with one of the
following: PSA progression defined by a minimum of 3 rising PSA levels with an
interval of >=1 week between each determination. The PSA value at screening must be
>=5 microgram (µg)/L (5 ng/mL) if PSA is the only indication of progression; subjects
on systemic glucocorticoids for control of symptoms must have documented PSA
progression by PCWG3 while on systemic glucocorticoids prior to commencing Cycle 1 Day
1 treatment.

- Radiographic progression of soft tissue disease by PCWG3-modified RECIST 1.1 criteria
or bone metastasis with 2 or more documented new bone lesions on a bone scan with or
without PSA progression

- Eastern Cooperative Oncology Group performance status of 0 or 1

- Life expectancy >12 weeks

- Able to swallow and retain orally administered medication

- Must have adequate organ function as defined by the following values: white blood
cells >3 x 10^9/liter(L); absolute neutrophil count (ANC) >= 1.5 x 10^9/L; hemoglobin
>= 9 grams per decilitre (g/dL) subjects that required transfusion or growth factor
need to demonstrate stable hemoglobin for 7 days of 9 g/dL; platelets >=100 x 10^9/L;
prothrombin time (PT)/International normalized ration (INR) and partial thromboplastin
time (PTT) <= 1.5 x upper limit of normal (ULN); albumin >=2.5 g/dL; total bilirubin
<=1.5 x ULN; aspartate transaminase (AST) <=2.5 x ULN; alanine transaminase (ALT)
<=2.5 x ULN OR <5 x ULN; creatinine <=1.5 x ULN is acceptable for subjects with
documented liver metastases/tumor infiltration; creatinine clearance >= 50 mL/min;
ejection fraction>= lower limit of normal (LLN) by echocardiogram or multigated
acquisition (MUGA) and minimum of 50% left ventricular ejection fraction (LVEF);
testosterone <=50 nanograms per deciliter (ng/dL)

- Male subject with a female partner of childbearing potential or pregnant must agree to
use two acceptable methods of contraception from time of first dose of study treatment
until 4 months after the last dose of study treatments
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Surgery or local prostatic intervention (excluding a prostatic biopsy) less than 28
days of Cycle 1 Day 1.

- Subjects with neuroendocrine and/or small cell CRPC

- Recent prior therapy, defined as: Any investigational or approved non-biologic
anti-cancer drug (see exception below) within 14 days prior to the first dose of
GSK525762 and abiraterone/enzalutamide. Exception: For allowed androgen deprivation
therapy (hormonal, abiraterone, enzalutamide. Concomitant prednisone (or equivalent)
allowed in combination with abiraterone dosing, any nitrosoureas or mitomycin C within
42 days prior to the first dose of GSK525762 and abiraterone/enzalutamide, any
anti-cancer biologic agents within five half-lives prior to the first dose of
GSK525762 and abiraterone/enzalutamide, if the subject received radiotherapy <90 days
prior to study treatment, the irradiated lesion cannot be the only lesion used for
evaluating response. Exception: Any radiotherapy within 14 days prior to the first
dose of GSK525762 and abiraterone/enzalutamide must be limited to a single fraction of
radiotherapy for the purpose of palliation (confined to one field) is permitted, any
major surgery within 28 days prior to the first dose of GSK525762 and
abiraterone/enzalutamide

- Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated
respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding
episodes). Any serious and/or unstable pre-existing medical (aside from malignancy),
psychiatric disorder, or other conditions that could interfere with subject's safety,
obtaining informed consent or compliance to the study procedures, in the opinion of
the Investigator; systolic blood pressure higher than 150 millimeter of mercury (mmHg)
or diastolic blood pressure higher than 90 mmHg found on 2 separate occasions
separated by 1 week, despite adequate therapy, will be defined as uncontrolled
hypertension; uncontrolled diabetes mellitus (despite therapeutic, compliance
intervention) as defined by a hemoglobin A1c (HbA1c) level more than 8% and/or
occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first
dose of study drug.

- Cardiac abnormalities as evidenced by any of the following: Baseline QT interval
corrected for heart rate by Fridericia's formula (QTcF) interval >=450 milliseconds
(msec), clinically significant conduction abnormalities or arrhythmias, such as
subjects with second degree (Type II) or third degree atrio-ventricular block, history
or evidence of current =Class II congestive heart failure as defined by New York Heart
Association (NYHA), history of acute coronary syndromes (including unstable angina and
myocardial infarction), coronary angioplasty, or stenting within the past 3 months.
Subjects with a history of stent placement requiring ongoing anti-coagulant therapy
(e.g., clopidogrel, prasugrel) will not be permitted to enroll, known cardiac
metastasis.

- Subjects with history of known bleeding disorder(s) or history of clinically
significant hemorrhage (e.g., gastrointestinal , neurologic), within the past 6
months.

- Therapeutic-dose anticoagulation (e.g., warfarin, low-molecular weight heparin [LMWH],
or novel oral anticoagulants) must be discontinued and coagulation parameters must be
normalized prior to the first dose of abiraterone/enzalutimide. Prophylactic
anticoagulation, with low doses (per standard practice) of agents such as low
molecular weight heparin (LMWH), direct thrombin inhibitors, or factor Xa inhibitors
is permitted.

- Concurrent use of high dose aspirin (doses up to 81 mg oral dose daily allowed) and
non-steroidal anti-inflammatory drugs (NSAIDS), except for where NSAIDs provide
documented benefit over other analgesics, and then to be used with caution including
concomitant use of proton pump inhibitors).

- Any acute toxicities due to prior chemotherapy and / or radiotherapy that have not
resolved to a Common Terminology Criteria for Adverse Events version 4.0 grade <=1
with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy.

- The patient has an active second malignancy other than curatively resected basal cell
or squamous cell carcinoma of the skin, in situ carcinoma of the bladder, or other
cancers for which they are treated with curative intent with no active disease in the
3 years prior to enrollment.

- Subjects with known symptomatic brain metastasis are not suitable for enrolment.
Subjects with asymptomatic, stable, treated brain metastases are eligible for study
entry.

- History of seizure or any condition that may predispose subject to seizure (e.g.,
prior cortical stroke or significant brain trauma).

- History of loss of consciousness or transient ischemic attack within 12 months prior
to enrollment

- Subjects with symptomatic or impending cord compression unless appropriately treated
beforehand and clinically stable and asymptomatic.

- Subjects who have experienced a seizure or seizures within 6 months of study treatment
or who are currently being treated with cytochrome P450 enzyme inducing anti-epileptic
drugs for seizures (use of anti-epileptic drugs to control pain is allowed in subjects
not suffering from seizures unless drug is excluded due to Cytochrome P450 3A4
induction - phenytoin, carbamazepine, Phenobarbital.

- Current use of a prohibited medication or planned use of any forbidden medications
during treatment with GSK525762 and abiraterone/enzalutamide. This includes
medications with significant risk of Torsades de pointes as well as those that are
potent inducers or inhibitors of CYP3A4 enzymes or strong inhibitors of CYP2C8.

- Subjects with gastrointestinal disorders likely to interfere with absorption of the
study medication.

- Subjects with known bleeding diathesis will be excluded from the study.

- Current active liver or biliary disease (with the exception of Gilbert's syndrome or
asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease
per investigator assessment).

- Initiating bisphosphonate or denosumab therapy or adjusting dose/regimen within 3
months prior to Cycle 1 Day 1. Subjects on a stable bisphosphonate or denosumab
therapy are eligible and may continue.

- Any serious known immediate or delayed hypersensitivity reaction to GSK525762 or
idiosyncrasy to drugs chemically related to the investigational drugs. Additionally,
any known hypersensitivity to either enzalutamide, abiraterone or any excipients would
be excluded.

- Known history of human immunodeficiency virus (HIV)

- Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test
result at screening. Subjects with positive hepatitis C antibody due to prior resolved
disease can be enrolled only if a confirmatory negative hepatitis C ribonucleic acid
polymerase chain reaction is obtained.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Albury
Recruitment hospital [2] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [3] 0 0
GSK Investigational Site - Wahroonga
Recruitment hospital [4] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [5] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Malaga
Country [13] 0 0
Spain
State/province [13] 0 0
Sabadell (Barcelona)
Country [14] 0 0
Spain
State/province [14] 0 0
Santander
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The 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 CRPC, including approved agents
(e.g., abiraterone, enzalutamide) as well as investigational agents for mCRPC that have
proven to show efficacy and can be combined based on complimentary mechanism of action. As a
first step, the combination of GSK525762 will be evaluated as a combination with abiraterone
or enzalutamide in men with metastatic or advanced castrate-resistant prostate cancer who
have progressed on at least one line of prior androgen receptor (AR)-targeted therapy. 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). Arm A and Arm B will
further have 2 cohorts: A1, A2 and B1, B2 respectively based on prior lines of therapy (L2
[chemo-naive subjects treated with a second androgen-deprivation therapy] and Lx [subjects
treated with both prior androgen-deprivation therapy and chemotherapy]). During dose
escalation, both the treatment arms (A and B) will follow a modified Toxicity Probability
Interval (mTPI) design. Approximately 130 subjects will be enrolled worldwide in this study.
Subjects from both dose escalation and dose expansion may be combined to reach 30 subjects.
The total duration of study will be approximately 2 to 3 years. A subject will be considered
to have completed the study if they are followed until death.
Trial website
https://clinicaltrials.gov/show/NCT03150056
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications