Trial Outcomes & Findings for A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma (NCT NCT02178358)

Last Updated: 2022-02-25

Results Overview

OS defined as the time from the date of randomization to the date of death due to any cause. An overall survival event was defined as death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. The number of participants with overall survival events (deaths) is reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

132 participants

Primary outcome timeframe

Randomization to Date of Death from Any Cause (Up To 24 Months)

Results posted on

2022-02-25

Participant Flow

In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.

Participant milestones

Participant milestones
Measure	150 Milligram (mg) Galunisertib Monotherapy 150 mg galunisertib administered orally, twice daily (BID) for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Overall Study STARTED	20	74	38
Overall Study Received at Least 1 Dose of Study Drug	20	74	38
Overall Study COMPLETED	19	72	36
Overall Study NOT COMPLETED	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	150 Milligram (mg) Galunisertib Monotherapy 150 mg galunisertib administered orally, twice daily (BID) for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Overall Study Withdrawal by Subject	0	2	2
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	150 mg Galunisertib Monotherapy n=20 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy n=74 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy n=38 Participants Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	55 Participants n=7 Participants	28 Participants n=5 Participants	96 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	19 Participants n=7 Participants	10 Participants n=5 Participants	36 Participants n=4 Participants
Age, Continuous	60.6 years STANDARD_DEVIATION 7.8 • n=5 Participants	59.0 years STANDARD_DEVIATION 8.5 • n=7 Participants	58.6 years STANDARD_DEVIATION 11.8 • n=5 Participants	59.1 years STANDARD_DEVIATION 9.4 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	12 Participants n=7 Participants	1 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	62 Participants n=7 Participants	37 Participants n=5 Participants	115 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants	74 Participants n=7 Participants	38 Participants n=5 Participants	132 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment South Korea	7 Participants n=5 Participants	33 Participants n=7 Participants	13 Participants n=5 Participants	53 Participants n=4 Participants
Region of Enrollment Hong Kong	6 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Region of Enrollment China	0 Participants n=5 Participants	15 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment Taiwan	7 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment Thailand	0 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Weight	66.400 kilogram (kg) n=5 Participants	63.575 kilogram (kg) n=7 Participants	62.400 kilogram (kg) n=5 Participants	63.575 kilogram (kg) n=4 Participants
Height	162.84 Centimeter (cm) STANDARD_DEVIATION 7.38 • n=5 Participants	165.30 Centimeter (cm) STANDARD_DEVIATION 7.50 • n=7 Participants	166.55 Centimeter (cm) STANDARD_DEVIATION 5.69 • n=5 Participants	165.29 Centimeter (cm) STANDARD_DEVIATION 7.05 • n=4 Participants
BMI	24.806 kilogram per square metre (kg/m2) STANDARD_DEVIATION 4.105 • n=5 Participants	23.224 kilogram per square metre (kg/m2) STANDARD_DEVIATION 3.248 • n=7 Participants	22.843 kilogram per square metre (kg/m2) STANDARD_DEVIATION 3.062 • n=5 Participants	23.354 kilogram per square metre (kg/m2) STANDARD_DEVIATION 3.373 • n=4 Participants
Tobacco use Never	7 Participants n=5 Participants	28 Participants n=7 Participants	11 Participants n=5 Participants	46 Participants n=4 Participants
Tobacco use Former	7 Participants n=5 Participants	35 Participants n=7 Participants	22 Participants n=5 Participants	64 Participants n=4 Participants
Tobacco use Current	6 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	22 Participants n=4 Participants
Alcohol use Never	7 Participants n=5 Participants	29 Participants n=7 Participants	16 Participants n=5 Participants	52 Participants n=4 Participants
Alcohol use Former	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Alcohol use Current	13 Participants n=5 Participants	44 Participants n=7 Participants	20 Participants n=5 Participants	77 Participants n=4 Participants
Alcohol drinks per week	5.7 Standard alcohol drinks per week STANDARD_DEVIATION 7.2 • n=5 Participants	3.3 Standard alcohol drinks per week STANDARD_DEVIATION 4.7 • n=7 Participants	2.3 Standard alcohol drinks per week STANDARD_DEVIATION 2.8 • n=5 Participants	3.4 Standard alcohol drinks per week STANDARD_DEVIATION 4.8 • n=4 Participants

PRIMARY outcome

Timeframe: Randomization to Date of Death from Any Cause (Up To 24 Months)

Population: All randomized participants. Censored participants: Galunisertib Monotherapy =5, Galunisertib Plus Sorafenib Therapy = 16 and Sorafenib Plus Placebo Therapy = 7.

Outcome measures

Outcome measures
Measure	150 mg Galunisertib Monotherapy n=20 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy n=74 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy n=38 Participants Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Overall Survival (OS): Number of Events	15 Participants with events	58 Participants with events	31 Participants with events

SECONDARY outcome

Timeframe: Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours(h) Postdose; D14: Predose, 0.5-2, 3-5 h, Postdose; D15 Morning; D22 Morning; Predose C2 and C3 Predose D1

Population: All randomized participants who received at least one dose of study drug, with evaluable galunisertib PK data. The analyses conducted on galunisertib exposure parameter from both arms combined per the statistical analysis plan, as monotherapy and combination arm showed no difference in galunisertib PK.

Population mean (between-subject coefficient variance \[CV %\]) apparent clearance.

Outcome measures

Outcome measures
Measure	150 mg Galunisertib Monotherapy n=91 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Population Pharmacokinetics (PopPK): Mean Population Clearance of Galunisertib	33.6 Liter per hour (L/hr) Geometric Coefficient of Variation 48	—	—

SECONDARY outcome

Timeframe: Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours(h) Postdose; D14: Predose, 0.5-2, 3-5 h, Postdose; D15 Morning; D22 Morning; Predose C2 and C3 Predose D1

Population Vss \[distribution of galunisertib in the body at steady state\] after a single dose of galunisertib.

Outcome measures

Outcome measures
Measure	150 mg Galunisertib Monotherapy n=91 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Population Pharmacokinetics (PopPK): Steady State Apparent Volume of Distribution (Vss) of Galunisertib	192 Liters (L) Geometric Coefficient of Variation 69	—	—

SECONDARY outcome

Timeframe: Randomization to the Date of Objective Progressive Disease or Date of Death due to Study Disease, whichever came first (Up To 24 Months)

Population: All randomized participants. Censored participants: Galunisertib Monotherapy =2, Galunisertib Plus Sorafenib Therapy = 15 and Sorafenib Plus Placebo Therapy = 9.

TTP at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	150 mg Galunisertib Monotherapy n=20 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy n=74 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy n=38 Participants Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Time to Tumor Progression (TTP)	1.41 Months Interval 1.38 to 2.76	2.86 Months Interval 2.63 to 4.21	4.14 Months Interval 2.76 to 8.21

SECONDARY outcome

Timeframe: Randomization to Measured Progressive Disease or Death (Up To 24 Months)

Population: All randomized participants. Censored participants: Galunisertib Monotherapy =1, Galunisertib Plus Sorafenib Therapy = 8 and Sorafenib Plus Placebo Therapy = 5.

PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

Outcome measures

Outcome measures
Measure	150 mg Galunisertib Monotherapy n=20 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy n=74 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy n=38 Participants Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Progression-Free Survival (PFS)	1.41 Months Interval 1.38 to 2.76	2.86 Months Interval 2.63 to 4.07	4.14 Months Interval 2.76 to 5.59

SECONDARY outcome

Timeframe: Randomization to Measured Progressive Disease (Up To 24 Months)

Population: All randomized participants.

ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.

Outcome measures

Outcome measures
Measure	150 mg Galunisertib Monotherapy n=20 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy n=74 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy n=38 Participants Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	0.05 Percentage of participants Interval 0.001 to 0.249	0.027 Percentage of participants Interval 0.003 to 0.094	0.158 Percentage of participants Interval 0.06 to 0.313

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: All randomized participants who received at least one dose of study drug and with baseline and post-baseline EORTC QLQ-C30 data for each EORTC QLQ-C30 items.

EORTC QLQ-C30 consists of 30 items covered by 1 of 3 dimensions: 1. Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent). 2. Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much). 3. Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

Outcome measures

Outcome measures
Measure	150 mg Galunisertib Monotherapy n=19 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy n=65 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy n=35 Participants Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Global health status	43.42 units on a scale Standard Deviation 23.171	55.90 units on a scale Standard Deviation 22.473	58.57 units on a scale Standard Deviation 17.326
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Functional scale: Physical functioning	84.56 units on a scale Standard Deviation 16.338	82.87 units on a scale Standard Deviation 19.613	80.95 units on a scale Standard Deviation 16.580
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Functional scale: Role functioning	89.47 units on a scale Standard Deviation 14.918	82.05 units on a scale Standard Deviation 24.880	85.24 units on a scale Standard Deviation 19.289
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Functional Scale: Emotional Functioning	84.65 units on a scale Standard Deviation 18.271	87.18 units on a scale Standard Deviation 17.247	86.90 units on a scale Standard Deviation 13.898
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Functional Scale: Cognitive Functioning	89.47 units on a scale Standard Deviation 16.860	91.03 units on a scale Standard Deviation 14.754	85.71 units on a scale Standard Deviation 18.142
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Functional Scale: Social Functioning	83.33 units on a scale Standard Deviation 24.845	84.10 units on a scale Standard Deviation 19.859	84.29 units on a scale Standard Deviation 18.052
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Symptom Scale: Fatigue	21.05 units on a scale Standard Deviation 23.393	24.10 units on a scale Standard Deviation 22.444	25.40 units on a scale Standard Deviation 18.390
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Symptom Scale: Nausea and Vomiting	2.63 units on a scale Standard Deviation 8.358	3.85 units on a scale Standard Deviation 8.725	3.33 units on a scale Standard Deviation 8.856
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Symptom scale: Pain	17.54 units on a scale Standard Deviation 19.621	17.18 units on a scale Standard Deviation 25.340	14.76 units on a scale Standard Deviation 20.521
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Symptom scale: Dyspnoea	17.54 units on a scale Standard Deviation 28.040	11.79 units on a scale Standard Deviation 19.922	12.38 units on a scale Standard Deviation 18.232
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Symptom scale: Insomnia	21.05 units on a scale Standard Deviation 31.838	9.74 units on a scale Standard Deviation 19.296	16.19 units on a scale Standard Deviation 16.903
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Symptom scale: Appetite loss	15.79 units on a scale Standard Deviation 25.744	16.92 units on a scale Standard Deviation 25.768	18.10 units on a scale Standard Deviation 23.351
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Symptom scale: Constipation	5.26 units on a scale Standard Deviation 12.488	6.15 units on a scale Standard Deviation 13.033	6.67 units on a scale Standard Deviation 15.760
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Symptom scale: Diarrhoea	10.53 units on a scale Standard Deviation 19.413	4.62 units on a scale Standard Deviation 13.013	10.48 units on a scale Standard Deviation 17.660
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Symptom scale: Financial difficulties	15.79 units on a scale Standard Deviation 25.744	23.08 units on a scale Standard Deviation 26.954	20.95 units on a scale Standard Deviation 22.989

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC-QLQ HCC-18 data for each EORTC-QLQ HCC-18 items.

The EORTC QLQ-HCC-18 was an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30. EORTC QLQ-HCC 18 questionnaire included 8 symptom scales such as abdominal swelling, sex life, fatigue, body image, jaundice, nutrition, pain and fever. Each individual item ranges from 1 to 4, where 1 = "not at all" and 4 = "very much." All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a symptom scale/item represented a high level of symptomatology/problem.

Outcome measures

Outcome measures
Measure	150 mg Galunisertib Monotherapy n=19 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).	150 mg Galunisertib + 400 mg Sorafenib Therapy n=65 Participants 150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.	400 mg Sorafenib + Placebo Therapy n=35 Participants Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle). 400 mg sorafenib administered orally BID for 28 days.
Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score Abdominal swelling	24.56 units on a scale Standard Deviation 33.040	32.82 units on a scale Standard Deviation 31.453	27.62 units on a scale Standard Deviation 24.899
Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score Sex Life	28.07 units on a scale Standard Deviation 31.940	58.97 units on a scale Standard Deviation 35.242	46.08 units on a scale Standard Deviation 35.783
Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score Fatigue	32.16 units on a scale Standard Deviation 21.563	47.86 units on a scale Standard Deviation 29.128	46.98 units on a scale Standard Deviation 26.278
Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score Body Image	28.07 units on a scale Standard Deviation 26.089	36.15 units on a scale Standard Deviation 22.930	31.90 units on a scale Standard Deviation 20.758
Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score Jaundice	20.18 units on a scale Standard Deviation 25.202	27.69 units on a scale Standard Deviation 25.392	25.24 units on a scale Standard Deviation 21.531
Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score Nutrition	22.46 units on a scale Standard Deviation 21.223	34.05 units on a scale Standard Deviation 23.456	34.48 units on a scale Standard Deviation 18.611
Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score Pain	25.44 units on a scale Standard Deviation 18.732	25.38 units on a scale Standard Deviation 21.471	30.95 units on a scale Standard Deviation 21.822
Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score Fever	14.04 units on a scale Standard Deviation 16.909	25.38 units on a scale Standard Deviation 25.019	20.48 units on a scale Standard Deviation 20.646

Adverse Events

150 mg Galunisertib Monotherapy

Serious events: 6 serious events

Other events: 17 other events

Deaths: 15 deaths

150 mg Galunisertib + 400 mg Sorafenib Therapy

Serious events: 31 serious events

Other events: 73 other events

Deaths: 58 deaths

400 mg Sorafenib + Placebo Therapy

Serious events: 11 serious events

Other events: 38 other events

Deaths: 31 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of less than 90 days from the time submitted to the sponsor for review.The PI will remove from publication the information which the sponsor reasonably thinks would jeopardize its intellectual property interests or delay the publication until the publication no longer jeopardizes its intellectual property interests.
Publication restrictions are in place

Restriction type: OTHER