Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor (FGF) Pathway Signaling
CompletedPhase 1Results postedLast updated 19 August 2019
What this trial tests
Phase 1 trial testing GSK3052230 in Neoplasms in 65 participants. Completed in 24 October 2017.
18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)Primary· Median of 28.5 weeks
An AE is any untoward medical occurrence in a clinical investigation participant, 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, protocol-specific events including drug-induced liver injury with hyperbilirubinaemia, any new primary cancers, cardiac toxicity including Left Ventricular Ejection Fraction (LVEF) changes or treatment eme
Non-serious AEs
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
3
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
3
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
14
5 mg/kg GSK3052230 + Docetaxel: Arm B
3
10 mg/kg GSK3052230 + Docetaxel: Arm B
3
20 mg/kg GSK3052230 + Docetaxel: Arm B
3
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
3
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
24
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
8
SAEs
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
3
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
5
5 mg/kg GSK3052230 + Docetaxel: Arm B
2
10 mg/kg GSK3052230 + Docetaxel: Arm B
3
20 mg/kg GSK3052230 + Docetaxel: Arm B
1
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
5
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
4
Number of Participants With Severe AEs and SAEsPrimary· Median of 28.5 weeks
The severity of AEs were graded utilizing National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.3. Grade 1 represents mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 represents moderate; minimal, local or noninvasive intervention indicated. Grade 3 represents severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 represents life-threatening consequences; urgent intervention indicated. Grade
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
5 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Docetaxel: Arm B
0
20 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
1
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
2
5 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Docetaxel: Arm B
0
20 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
7
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
1
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
1
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
1
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
8
5 mg/kg GSK3052230 + Docetaxel: Arm B
2
10 mg/kg GSK3052230 + Docetaxel: Arm B
2
20 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
1
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
17
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
4
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
2
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
2
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
4
5 mg/kg GSK3052230 + Docetaxel: Arm B
1
10 mg/kg GSK3052230 + Docetaxel: Arm B
1
20 mg/kg GSK3052230 + Docetaxel: Arm B
3
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2
Number of Participants Withdrew Due to AEsPrimary· Median of 28.5 weeks
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The AEs leading to permanent discontinuation from the study has been reported.
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
5 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Docetaxel: Arm B
1
20 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
1
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
3
Number of Participants With Dose ReductionPrimary· Median of 28.5 weeks
Dose reduction and delays were done due to toxicity, or in the interest of participant's safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose reduction has been reported.
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
1
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
3
5 mg/kg GSK3052230 + Docetaxel: Arm B
1
10 mg/kg GSK3052230 + Docetaxel: Arm B
0
20 mg/kg GSK3052230 + Docetaxel: Arm B
2
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
Number of Participants With Dose DelaysPrimary· Median of 28.5 weeks
Dose reduction and delays were done due to toxicity, or in the interest of participant's safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose delay has been reported.
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
2
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
4
5 mg/kg GSK3052230 + Docetaxel: Arm B
2
10 mg/kg GSK3052230 + Docetaxel: Arm B
1
20 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
12
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
1
Treatment Duration With GSK3052230Primary· Median of 28.5 weeks
The number of participants administered study treatment were summarized according to the duration of therapy. The extent of treatment exposure is calculated as the number of cycles administered. The duration of exposure to study treatment is calculated from first day to last day of treatment plus 1 day. Median and full range (minimum and maximum) has been reported.
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
7.0
3 – 8
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
15.0
5 – 20
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
8.0
2 – 13
5 mg/kg GSK3052230 + Docetaxel: Arm B
6.0
2 – 7
10 mg/kg GSK3052230 + Docetaxel: Arm B
4.0
2 – 14
20 mg/kg GSK3052230 + Docetaxel: Arm B
6.0
3 – 8
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
6.0
4 – 8
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
11.0
1 – 23
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
3.0
1 – 32
Number of Participants With Dose-Limiting Toxicities (DLT)Primary· Median of 28.5 weeks
DLT is defined as toxicities due to GSK3052230 or due to the combination of GSK3052230 with chemotherapy within Cycle 1 (first 21 days of period on study) that are unlikely to be due to another cause, such as the known effects of cytotoxics chemotherapy alone, disease progression, or accident, and protocol-specified criteria. Clinically significant toxicities that persist or occur beyond Cycle 1 that the investigator and GlaxoSmithKline (GSK) medical monitor consider dose-limiting may also be designated a DLT for the purpose of establishing Maximum tolerated dose (MTD). Number of participants
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
5 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Docetaxel: Arm B
0
20 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
1
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
3
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)Primary· Baseline and up to Median of 28.5 weeks
Blood pressure was measured in a semi-supine position after 5 minutes of rest. Blood pressure was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented. NA indicates that data were not available as standard deviation could not be calculated for a single par
DBP, n=3, 2, 9, 3, 2, 2, 3, 21, 5
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
6.3
± 16.17
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0.5
± 12.02
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
2.0
± 10.39
5 mg/kg GSK3052230 + Docetaxel: Arm B
-0.6
± 3.06
10 mg/kg GSK3052230 + Docetaxel: Arm B
6.0
± 2.83
20 mg/kg GSK3052230 + Docetaxel: Arm B
3.5
± 9.19
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2.3
± 7.64
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
12.8
± 8.38
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
10.6
± 2.30
SBP, n=3, 1, 13, 2, 2, 2, 3, 21, 4
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
-12.3
± 15.31
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
-14.0
± NA
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
9.6
± 10.16
5 mg/kg GSK3052230 + Docetaxel: Arm B
10.5
± 14.85
10 mg/kg GSK3052230 + Docetaxel: Arm B
17.5
± 3.54
20 mg/kg GSK3052230 + Docetaxel: Arm B
6.0
± 22.63
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
3.0
± 13.00
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
12.5
± 13.21
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
18.7
± 15.97
Change From Baseline in Heart RatePrimary· Baseline and up to Median of 28.5 weeks
Heart rate was measured in a semi-supine position after 5 minutes of rest. Heart rate was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
-0.3
± 15.31
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
3.2
± 24.74
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
8.0
± 23.67
5 mg/kg GSK3052230 + Docetaxel: Arm B
28.0
± 42.79
10 mg/kg GSK3052230 + Docetaxel: Arm B
10.5
± 19.33
20 mg/kg GSK3052230 + Docetaxel: Arm B
0.6
± 3.06
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
-5.0
± 1.73
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2.8
± 20.49
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
24.4
± 21.56
Change From Baseline in TemperaturePrimary· Baseline and up to Median of 28.5 weeks
Temperature was measured in a semi-supine position after 5 minutes of rest. Temperature was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
-0.30
± 0.361
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
-0.38
± 0.608
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0.35
± 0.917
5 mg/kg GSK3052230 + Docetaxel: Arm B
0.10
± 0.283
10 mg/kg GSK3052230 + Docetaxel: Arm B
1.03
± 1.795
20 mg/kg GSK3052230 + Docetaxel: Arm B
-0.03
± 0.058
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
-0.23
± 0.208
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
-0.16
± 0.899
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0.12
± 0.742
Number of Participants With Clinically Significant Findings for 12-lead Electrocardiogram (ECG)Primary· Median of 28.5 weeks
A single 12-lead ECG was performed at the specified timepoints during the study where the participant was instructed to be in semi-recumbent position for 5 minutes before obtaining the ECG. An ECG machine that automatically calculated the heart rate and measures like the PR, QRS, QT, and corrected QT intervals. Number of participants with worst-case post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported.
Abnormal not clinically significant
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
2
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
8
5 mg/kg GSK3052230 + Docetaxel: Arm B
2
10 mg/kg GSK3052230 + Docetaxel: Arm B
2
20 mg/kg GSK3052230 + Docetaxel: Arm B
3
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
1
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
12
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2
Abnormal clinically significant
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
1
5 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Docetaxel: Arm B
0
20 mg/kg GSK3052230 + Docetaxel: Arm B
0
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
3
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
3
Number of Participants With Abnormal Echocardiogram (ECHO) FindingsPrimary· Median of 28.5 weeks
Echocardiography scans were obtained at given time points using an echocardiogram and the findings for left ventricular ejection fraction (LVEF) were obtained. LVEF values at end of treatment (EOT) were recorded as no change or any increase and any decrease values. Only those participants available at the specified time points were analyzed.
No change or any increase
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
0
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
1
5 mg/kg GSK3052230 + Docetaxel: Arm B
0
20 mg/kg GSK3052230 + Docetaxel: Arm B
1
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
2
Any Decrease
Group
Value
95% CI
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
1
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
1
5 mg/kg GSK3052230 + Docetaxel: Arm B
1
20 mg/kg GSK3052230 + Docetaxel: Arm B
1
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
3
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events (SAEs) and non-serious adverse events (AEs) were be collected from the start of study treatment and up to Median of 28.5 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Serious: 0/3 (0%)
Deaths: 0/3
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Serious: 3/3 (100%)
Deaths: 0/3
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Serious: 5/14 (36%)
Deaths: 0/14
5 mg/kg GSK3052230 + Docetaxel: Arm B
Serious: 2/3 (67%)
Deaths: 0/3
10 mg/kg GSK3052230 + Docetaxel: Arm B
Serious: 3/3 (100%)
Deaths: 0/3
20 mg/kg GSK3052230 + Docetaxel: Arm B
Serious: 1/3 (33%)
Deaths: 0/3
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Serious: 0/3 (0%)
Deaths: 0/3
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Serious: 5/25 (20%)
Deaths: 0/25
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Serious: 4/8 (50%)
Deaths: 1/8
Serious adverse events (29 terms)
Reaction
System
5 mg/kg GSK3052230 + Pacli…
10 mg/kg GSK3052230 + Pacl…
20 mg/kg GSK3052230 + Pacl…
5 mg/kg GSK3052230 + Docet…
10 mg/kg GSK3052230 + Doce…
20 mg/kg GSK3052230 + Doce…
10 mg/kg GSK3052230 + Peme…
15 mg/kg GSK3052230 + Peme…
20 mg/kg GSK3052230 + Peme…
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
Respiratory tract infection
Infections and infestations
—
—
—
—
—
—
—
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
Lung infection
Infections and infestations
—
—
—
—
—
—
—
—
—
Stenotrophomonas infection
Infections and infestations
—
—
—
—
—
—
—
—
—
Asthenia
General disorders
—
—
—
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
Diabetes mellitus
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
Ataxia
Nervous system disorders
—
—
—
—
—
—
—
—
—
Confusional state
Psychiatric disorders
—
—
—
—
—
—
—
—
—
Myocardial infarction
Cardiac disorders
—
—
—
—
—
—
—
—
—
Pericardial effusion
Cardiac disorders
—
—
—
—
—
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
Intestinal ischaemia
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
Intestinal perforation
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
Infusion related reaction
Injury, poisoning and procedural complications
—
—
—
—
—
—
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—
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Femur fracture
Injury, poisoning and procedural complications
—
—
—
—
—
—
—
—
—
Clostridium difficile infection
Infections and infestations
—
—
—
—
—
—
—
—
—
Pneumonia pseudomonal
Infections and infestations
—
—
—
—
—
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
—
—
—
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Other adverse events (195 terms — click to expand)
This phase IB trial aims to identify anticancer activity of GSK3052230 in subjects with malignancies with abnormal dependence on FGF pathway signaling. Combination doses of GSK3052230 with standard of care chemotherapy in the first and second line or greater setting of metastatic squamous non-small cell lung cancer (NSCLC) and first line malignant pleural mesothelioma subjects will be studied in the 3+3 dose-escalation design. This will be a multi-arm, multicenter, non-randomized, parallel-group, uncontrolled, open-label Phase IB study designed to evaluate the safety, tolerability and preliminary activity of GSK3052230 in combination with paclitaxel + carboplatin (Arm A), in combination with docetaxel (Arm B), or in combination with pemetrexed + cisplatin (Arm C). Approximately 70 subjects will be enrolled in the study (approximately up to 120 may be enrolled).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum
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NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 19 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01868022.