A Study of Galunisertib in Participants With Myelodysplastic Syndromes
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the effect of the study drug known as galunisertib in participants with myelodysplastic syndromes (MDS). Participants with different degrees of disease (very low, low, and intermediate risk) will be studied. The study treatment is expected to last about 6 months for each participant.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Phase (ph) 2: Galunisertib + BSC Ph 2. 150 milligrams Galunisertib given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. Treatment is expected to last for 6 cycles. Participants may receive additional cycles if they are deriving clinical benefit. |
Drug: Galunisertib
Administered orally
Other Names:
|
Placebo Comparator: Ph 3: Placebo + BSC Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive BSC according to institutional guidelines. Treatment is expected to last for 6 cycles. Participants may receive additional cycles if they are deriving clinical benefit. This arm is contingent on the data from the phase 2 arm. |
Drug: Placebo
Administered orally
|
Experimental: Ph 3: Galunisertib + BSC 150 milligrams Galunisertib given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. Treatment is expected to last for 6 cycles. Participants may receive additional cycles if they are deriving clinical benefit. This arm is contingent on the data from the phase 2 arm. |
Drug: Galunisertib
Administered orally
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Hematological Improvement (HI) [Baseline through end of study treatment (24 weeks)]
Percentage of participants with hematological improvement (HI) based on International Working Group (IWG) 2006 criteria in participants with very low, low, and intermediate-risk myelodysplastic syndromes treated with Galunisertib plus best supportive care, as assessed by the International Prognostic Scoring System (IPSS-R). To be classified as an HI responder, the HI response must have lasted at least 8 weeks (56 days).
- Percentage of Participants Who Are Transfusion-free or Have Hemoglobin (Hb) Increase ≥1.5 Grams/Deciliter Maintained for 8 Weeks During Phase 3 [Baseline through end of study treatment (24 weeks)]
Comparison of the percentage of participants with very low-, low-,and intermediate-risk MDS who were transfusion-free or had an increase ≥1.5 g/dL in hemoglobin (Hb) maintained for at least 8 weeks within the first 24 weeks of treatment with galunisertib plus best supportive care or placebo plus best supportive care and assessed by IPSS-R. The Phase 3 portion of this study was not conducted because efficacy level required in phase 2 to move forward to phase 3 was not achieved.
Secondary Outcome Measures
- Change From Baseline in Brief Fatigue Inventory (BFI) [Baseline, Follow up (final visit up to 24 months)]
The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity of fatigue is assessed using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine.
- Change From Baseline in EuroQol 5-Dimension 5 Level Instrument [Phase 3: Baseline, Cycle 2, Cycle 4, Cycle 6 (Cycle = 28 days)]
EuroQol 5-Dimension 5 Level Instrument (EQ-5D-5L) was not conducted, trial terminated prior to Phase 3. No data collected.
- Percentage of Participants With Cytogenetic Response [Baseline through end of study treatment (24 weeks)]
Percentage of Participants with Cytogenetic Response with either complete or partial response. Complete cytogenetic response is the disappearance of the chromosomal abnormality without appearance of new ones. Partial cytogenetic response is at least 50% reduction of the chromosomal abnormality.
- Percentage of Participants Who Are Hospitalized (Resource Utilization) [Baseline through end of study treatment (24 weeks)]
Percentage of any participant with a hospitalization admission and discharge date on the same day are counted as a half-day in the duration of hospitalization.
- Population Pharmacokinetics (PK): Mean Population Clearance of Galunisertib [Day 1 pre-dose & between 0.5 to 2 hours post dose; Day 14 pre-dose, between 0.5 to 2 & between 3 to 5 hours post dose; Days 15 & 16 (if logistically possible) between 0.5 to 2 hours post dose]
Population mean (between-participant coefficient variation [CV%]) apparent clearance.
- Overall Survival (OS) [Baseline to date of death from any cause (Up to 2 years)]
Overall survival is defined as the time from the date of first dose to the date of death from any cause.
- Number of Participants With a Change in Bone Marrow Fibrosis Grading [Baseline, Cycle 6 (Cycle = 28 days)]
Change from baseline in bone marrow fibrosis measured the number of participants with a change in bone marrow fibrosis grading (negative, mild, moderate, and severe).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed diagnosis of MDS based on the World Health Organization (WHO) criteria
-
Participants with 5q deletions are allowed only if they have failed or are intolerant of lenalidomide treatment
-
Participants must have a Revised International Prognostic Scoring System (IPSS-R) category of very low-, low-, or intermediate-risk disease
-
In the 8 weeks prior to registration, participants in phase 2 should have anemia with Hb ≤10.0 g/dL (based on the average of 2 baseline measurements and untransfused for at least 1 week) with or without red blood cell (RBC) transfusion dependence confirmed for a minimum of 8 weeks before enrollment
-
For phase 3, participants should have anemia with RBC transfusion dependence confirmed within 8 weeks before enrollment
-
Performance status ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
Exclusion Criteria:
-
No history of moderate or severe cardiac disease
-
No prior history of acute myeloid leukemia (AML)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dresden | Germany | 01307 | |
2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Düsseldorf | Germany | 40479 | |
3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jena | Germany | 07747 | |
4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lübeck | Germany | 23562 | |
5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ulm | Germany | 89081 | |
6 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Westerstede | Germany | 26655 | |
7 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Firenze | Italy | 50134 | |
8 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Novara | Italy | 28100 | |
9 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rome | Italy | 00161 | |
10 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | Spain | 08035 | |
11 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madrid | Spain | 28050 | |
12 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oviedo | Spain | 33011 | |
13 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salamanca | Spain | 37007 | |
14 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | Spain | 46026 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15242
- H9H-MC-JBAV
- 2013-003235-30
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | This is a single-arm study (Galunisertib at 150 milligram [mg]); the Galunisertib at 80 mg was considered exploratory and only conducted in parallel with the main study, at one site in Spain. |
Arm/Group Title | Galunisertib at 150 mg | Galunisertib at 80 mg |
---|---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). | Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). |
Period Title: Overall Study | ||
STARTED | 41 | 2 |
Received At Least 1 Dose of Study Drug | 41 | 2 |
COMPLETED | 29 | 1 |
NOT COMPLETED | 12 | 1 |
Baseline Characteristics
Arm/Group Title | Galunisertib at 150 mg | Galunisertib at 80 mg | Total |
---|---|---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. | Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. | Total of all reporting groups |
Overall Participants | 41 | 2 | 43 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
70.49
(7.65)
|
62.50
(10.61)
|
70.12
(7.83)
|
Sex: Female, Male (Count of Participants) | |||
Female |
15
36.6%
|
1
50%
|
16
37.2%
|
Male |
26
63.4%
|
1
50%
|
27
62.8%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
5
12.2%
|
0
0%
|
5
11.6%
|
Not Hispanic or Latino |
32
78%
|
2
100%
|
34
79.1%
|
Unknown or Not Reported |
4
9.8%
|
0
0%
|
4
9.3%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
White |
41
100%
|
2
100%
|
43
100%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||
Italy |
8
19.5%
|
0
0%
|
8
18.6%
|
Germany |
23
56.1%
|
0
0%
|
23
53.5%
|
Spain |
10
24.4%
|
2
100%
|
12
27.9%
|
IPSS-R Prognostic Risk Score (Count of Participants) | |||
Very Low= (≤1.5) |
2
4.9%
|
0
0%
|
2
4.7%
|
Low= (>1.5 - 3) |
30
73.2%
|
1
50%
|
31
72.1%
|
Intermediate= (>3 - 4.5) |
9
22%
|
1
50%
|
10
23.3%
|
Outcome Measures
Title | Percentage of Participants With Hematological Improvement (HI) |
---|---|
Description | Percentage of participants with hematological improvement (HI) based on International Working Group (IWG) 2006 criteria in participants with very low, low, and intermediate-risk myelodysplastic syndromes treated with Galunisertib plus best supportive care, as assessed by the International Prognostic Scoring System (IPSS-R). To be classified as an HI responder, the HI response must have lasted at least 8 weeks (56 days). |
Time Frame | Baseline through end of study treatment (24 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received at least one dose of study drug. |
Arm/Group Title | Galunisertib at 150 mg | Arm: Galunisertib at 80 mg |
---|---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. | Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14... more days with no study drug (28 day cycles). Completed participants completed at least 6 cycles. |
Measure Participants | 41 | 2 |
Number (95% Confidence Interval) [percentage of participants] |
31.7
77.3%
|
0.0
0%
|
Title | Percentage of Participants Who Are Transfusion-free or Have Hemoglobin (Hb) Increase ≥1.5 Grams/Deciliter Maintained for 8 Weeks During Phase 3 |
---|---|
Description | Comparison of the percentage of participants with very low-, low-,and intermediate-risk MDS who were transfusion-free or had an increase ≥1.5 g/dL in hemoglobin (Hb) maintained for at least 8 weeks within the first 24 weeks of treatment with galunisertib plus best supportive care or placebo plus best supportive care and assessed by IPSS-R. The Phase 3 portion of this study was not conducted because efficacy level required in phase 2 to move forward to phase 3 was not achieved. |
Time Frame | Baseline through end of study treatment (24 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received at least one dose of study drug during Phase 3. |
Arm/Group Title | Galunisertib at 150 mg | Galunisertib at 80 mg |
---|---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. | Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14... more days with no study drug (28 day cycles). Completed participants completed at least 6 cycles. |
Measure Participants | 0 | 0 |
Title | Change From Baseline in Brief Fatigue Inventory (BFI) |
---|---|
Description | The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity of fatigue is assessed using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine. |
Time Frame | Baseline, Follow up (final visit up to 24 months) |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received at least one dose of study drug. |
Arm/Group Title | Galunisertib at 150 mg | Galunisertib at 80 mg |
---|---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. | Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. |
Measure Participants | 41 | 2 |
Current Fatigue at Follow-up |
0.818
(0.42)
|
-1.005
(2.08)
|
Usual Fatigue at Follow-up |
-0.017
(0.37)
|
-0.157
(1.87)
|
Worst Fatigue at Follow-up |
-0.191
(0.38)
|
-0.063
(1.93)
|
Title | Change From Baseline in EuroQol 5-Dimension 5 Level Instrument |
---|---|
Description | EuroQol 5-Dimension 5 Level Instrument (EQ-5D-5L) was not conducted, trial terminated prior to Phase 3. No data collected. |
Time Frame | Phase 3: Baseline, Cycle 2, Cycle 4, Cycle 6 (Cycle = 28 days) |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received at least one dose of study drug during Phase 3. |
Arm/Group Title | Galunisertib at 150 mg | Galunisertib at 80 mg |
---|---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. | Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. |
Measure Participants | 0 | 0 |
Title | Percentage of Participants With Cytogenetic Response |
---|---|
Description | Percentage of Participants with Cytogenetic Response with either complete or partial response. Complete cytogenetic response is the disappearance of the chromosomal abnormality without appearance of new ones. Partial cytogenetic response is at least 50% reduction of the chromosomal abnormality. |
Time Frame | Baseline through end of study treatment (24 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received at least one dose of study drug. |
Arm/Group Title | Galunisertib at 150 mg | Galunisertib at 80 mg |
---|---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. | Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14... more days with no study drug (28 day cycles). Completed participants completed at least 6 cycles. |
Measure Participants | 41 | 2 |
Number (95% Confidence Interval) [percentage of participants] |
2.4
5.9%
|
0
0%
|
Title | Percentage of Participants Who Are Hospitalized (Resource Utilization) |
---|---|
Description | Percentage of any participant with a hospitalization admission and discharge date on the same day are counted as a half-day in the duration of hospitalization. |
Time Frame | Baseline through end of study treatment (24 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received at least one dose of study drug. |
Arm/Group Title | Galunisertib at 150 mg | Galunisertib at 80 mg |
---|---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. | Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14... more days with no study drug (28 day cycles). Completed participants completed at least 6 cycles. |
Measure Participants | 41 | 2 |
Number [percentage of participants] |
24.3
59.3%
|
0
0%
|
Title | Population Pharmacokinetics (PK): Mean Population Clearance of Galunisertib |
---|---|
Description | Population mean (between-participant coefficient variation [CV%]) apparent clearance. |
Time Frame | Day 1 pre-dose & between 0.5 to 2 hours post dose; Day 14 pre-dose, between 0.5 to 2 & between 3 to 5 hours post dose; Days 15 & 16 (if logistically possible) between 0.5 to 2 hours post dose |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least one dose of study drug, regardless of dose, with evaluable PK data. |
Arm/Group Title | Galunisertib |
---|---|
Arm/Group Description | Galunisertib given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). |
Measure Participants | 43 |
Geometric Mean (Geometric Coefficient of Variation) [Liter per hour (L/h)] |
32
(52)
|
Title | Overall Survival (OS) |
---|---|
Description | Overall survival is defined as the time from the date of first dose to the date of death from any cause. |
Time Frame | Baseline to date of death from any cause (Up to 2 years) |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received at least one dose of study drug excluding the exploratory participants. |
Arm/Group Title | Galunisertib at 150 mg |
---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. |
Measure Participants | 41 |
Median (Full Range) [days] |
679
|
Title | Number of Participants With a Change in Bone Marrow Fibrosis Grading |
---|---|
Description | Change from baseline in bone marrow fibrosis measured the number of participants with a change in bone marrow fibrosis grading (negative, mild, moderate, and severe). |
Time Frame | Baseline, Cycle 6 (Cycle = 28 days) |
Outcome Measure Data
Analysis Population Description |
---|
Participants who received at least one dose of study drug and had both a baseline and postbaseline assessment excluding the exploratory participants. |
Arm/Group Title | Galunisertib at 150 mg |
---|---|
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. |
Measure Participants | 30 |
Number [participants] |
11
26.8%
|
Adverse Events
Time Frame | Baseline through end of study treatment or death from any cause (Up to 2 years) | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Galunisertib at 150 mg | Galunisertib at 80 mg | ||
Arm/Group Description | Galunisertib at 150 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). | Exploratory arm: Galunisertib at 80 mg given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). | ||
All Cause Mortality |
||||
Galunisertib at 150 mg | Galunisertib at 80 mg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Galunisertib at 150 mg | Galunisertib at 80 mg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 8/41 (19.5%) | 0/2 (0%) | ||
Blood and lymphatic system disorders | ||||
Febrile neutropenia | 1/41 (2.4%) | 1 | 0/2 (0%) | 0 |
Lymphadenopathy | 1/41 (2.4%) | 1 | 0/2 (0%) | 0 |
Cardiac disorders | ||||
Cardiac failure | 2/41 (4.9%) | 2 | 0/2 (0%) | 0 |
Gastrointestinal disorders | ||||
Crohn's disease | 1/41 (2.4%) | 1 | 0/2 (0%) | 0 |
Retroperitoneal haemorrhage | 1/41 (2.4%) | 1 | 0/2 (0%) | 0 |
Infections and infestations | ||||
Pneumonia | 1/41 (2.4%) | 2 | 0/2 (0%) | 0 |
Respiratory syncytial virus infection | 1/41 (2.4%) | 1 | 0/2 (0%) | 0 |
Tongue abscess | 1/41 (2.4%) | 1 | 0/2 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Respiratory failure | 2/41 (4.9%) | 2 | 0/2 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Galunisertib at 150 mg | Galunisertib at 80 mg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 33/41 (80.5%) | 2/2 (100%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 3/41 (7.3%) | 18 | 0/2 (0%) | 0 |
Gastrointestinal disorders | ||||
Diarrhoea | 7/41 (17.1%) | 8 | 0/2 (0%) | 0 |
Nausea | 3/41 (7.3%) | 4 | 0/2 (0%) | 0 |
Vomiting | 5/41 (12.2%) | 6 | 0/2 (0%) | 0 |
General disorders | ||||
Asthenia | 5/41 (12.2%) | 13 | 1/2 (50%) | 1 |
Fatigue | 4/41 (9.8%) | 4 | 0/2 (0%) | 0 |
Oedema peripheral | 3/41 (7.3%) | 3 | 0/2 (0%) | 0 |
Pyrexia | 5/41 (12.2%) | 8 | 0/2 (0%) | 0 |
Infections and infestations | ||||
Nasopharyngitis | 4/41 (9.8%) | 4 | 0/2 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Back pain | 3/41 (7.3%) | 3 | 0/2 (0%) | 0 |
Nervous system disorders | ||||
Dizziness | 3/41 (7.3%) | 3 | 0/2 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 0/41 (0%) | 0 | 1/2 (50%) | 1 |
Rhinorrhoea | 0/41 (0%) | 0 | 1/2 (50%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only 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 that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Eli Lilly and Company |
Phone | 800-545-5979 |
ClinicalTrials.gov@lilly.com |
- 15242
- H9H-MC-JBAV
- 2013-003235-30