A Study for Participants With Metastatic Renal Cell Carcinoma
Study Details
Study Description
Brief Summary
This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a multicenter, Phase 2 study of enzastaurin and sunitinib versus placebo and sunitinib as first-line therapy in participants with metastatic renal cell carcinoma, containing 2 parts. Part 1 is a safety lead-in study with 12 participants and possible dose escalation. Part 2 is a randomized, double-blind, Phase 2 study in 110 participants.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1 Arm A: Enzastaurin + Sunitinib (Cohort 1): On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle. (Cohort 2): Cycle 1, Day 1 loading dose 375 mg of Enzastaurin administered po three times a day (TID), followed by 250 mg, po, BID continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) days 29-42. Phase 2 (Part 2): Randomized Double-Blind: Dosing was determined by Part 1. Part 2 was not activated per recommendation of safety review committee. Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, (TID) three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6 week cycle. Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42. |
Drug: Enzastaurin
Administered orally
Other Names:
Drug: Sunitinib
Administered orally
|
| Placebo Comparator: Part 2 Arm B: Sunitinib + Placebo Part 2 was not activated per recommendation of safety review committee. Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42. Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, days 2-42. |
Drug: Sunitinib
Administered orally
Drug: Placebo
Administered orally
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) in Part 2 [Randomization to Measured Progressive Disease (PD) (Up to 24 Months)]
Progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first.
Secondary Outcome Measures
- Overall Survival (OS) in Part 2 [Randomization to Death from Any Cause (Up to 24 Months)]
OS time was defined as the number of months between the date of randomization and the date of death due to any cause.
- Time-To-Tumor Progression in Part 2 [Randomization to the Date of Objective Progressive Disease or Date of Death due to Study Disease, whichever came first (Up to 24 Months)]
Time to tumor progression (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.
- Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1 [Randomization to Study Completion (Up to 6 Cycles)]
Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
- Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 [Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose]
Pharmacokinetics (PK) was assessed in participants to determine the area under the concentration time curve during one dosing interval at steady state (AUCτ,ss) of Enzastaurin, LSN326020 and total Analytes. τ equals 12 hours for Enzastaurin, LSN326020 and total Analytes.
- PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1 [Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose]
PK was assessed in participants to determine the maximum concentration at steady state (Cmax, ss) of Enzastaurin + LSN326020 + total analytes.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants with metastatic Renal Cell Carcinoma (RCC) who have not received prior treatment with systemic (adjuvant or neoadjuvant) therapy for RCC (including targeted therapy such as tyrosine kinase inhibitors or bevacizumab, immunotherapy, chemotherapy, hormonal, or investigational therapy)
-
Histologically confirmed RCC with metastases with a component of clear (conventional) cell histology
-
Evidence of unidimensional measurable disease, measured by computed tomography (CT) scan or magnetic resonance imaging (MRI)
-
Primary tumor has been surgically removed by nephrectomy or nephron-sparing surgery
-
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
-
Participants must sign an informed consent document
Exclusion Criteria:
-
Have received prior treatment with sunitinib or enzastaurin
-
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
-
Have had any of the following within 12 months prior to study drug administration:
-
myocardial infarction,
-
severe/unstable angina,
-
coronary/peripheral artery bypass graft,
-
symptomatic congestive heart failure (CHF),
-
cerebrovascular accident,
-
transient ischemic attack, or
-
pulmonary embolism
-
Note: Ongoing treatment with therapeutic doses of Coumadin® (warfarin) or a derivative of Coumadin or phenprocoumon is not allowed, but prophylactic, low-dose Coumadin (≤ 2 mg daily) for deep vein thrombosis is allowed. In such cases, prothrombin time/international normalization ratio (PT/INR) should be very closely monitored as clinically indicated
-
Ongoing cardiac arrhythmias >New York Health Association Class II, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 millisecond (msec) for males or >470 msec for females.
-
Have uncontrolled hypertension [>150/100 millimeter of mercury (mm/Hg) despite optimal medical therapy], or history of poor compliance with antihypertensive treatment
-
Require concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inducer, for example, rifampicin or potent CYP3A inhibitors, such as ketoconazole.
-
Significant surgery or radiation therapy <4 weeks of starting study treatment. Prior palliative radiotherapy to metastatic lesion(s) is/are permitted, provided there is at least 1 measurable lesion that has not been irradiated
-
Participants who are pregnant or breast feeding
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. | Vienna | Austria | A1090 | |
| 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. | Villejuif | France | 94805 | |
| 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. | Rome | Italy | 00149 | |
| 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. | Warsaw | Poland | 00909 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 11531
- H6Q-MC-S061
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Part 1 completers finished 3 or more cycles and included those with progressive disease. Part 2 was not performed and was not activated due to sponsor broad decision to not pursue enzastaurin in solid tumors. |
| Arm/Group Title | Modified Regimen A (Cohort 1) | Regimen A (Cohort 2) |
|---|---|---|
| Arm/Group Description | On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle. Sunitinib 50 mg was administered orally, (QD) once daily, Days 1-28, then rest (no drug given) Days 29-42. | Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. |
| Period Title: Overall Study | ||
| STARTED | 11 | 6 |
| Progressive Disease | 6 | 1 |
| COMPLETED | 6 | 1 |
| NOT COMPLETED | 5 | 5 |
Baseline Characteristics
| Arm/Group Title | Modified Regimen A (Cohort 1) | Regimen A (Cohort 2) | Total |
|---|---|---|---|
| Arm/Group Description | On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. | Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. | Total of all reporting groups |
| Overall Participants | 11 | 6 | 17 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60.1
(5.44)
|
58.5
(8.42)
|
59.6
(6.42)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
45.5%
|
1
16.7%
|
6
35.3%
|
| Male |
6
54.5%
|
5
83.3%
|
11
64.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
11
100%
|
6
100%
|
17
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| 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 |
11
100%
|
6
100%
|
17
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) | |||
| Austria |
1
9.1%
|
1
16.7%
|
2
11.8%
|
| Poland |
6
54.5%
|
4
66.7%
|
10
58.8%
|
| Italy |
3
27.3%
|
0
0%
|
3
17.6%
|
| France |
1
9.1%
|
1
16.7%
|
2
11.8%
|
Outcome Measures
| Title | Progression Free Survival (PFS) in Part 2 |
|---|---|
| Description | Progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. |
| Time Frame | Randomization to Measured Progressive Disease (PD) (Up to 24 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors. |
| Arm/Group Title | Enzastaurin + Sunitinib | Sunitinib + Placebo |
|---|---|---|
| Arm/Group Description | Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, (TID) three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6-week cycle. Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42. | Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42. Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, Days 2-42. |
| Measure Participants | 0 | 0 |
| Title | Overall Survival (OS) in Part 2 |
|---|---|
| Description | OS time was defined as the number of months between the date of randomization and the date of death due to any cause. |
| Time Frame | Randomization to Death from Any Cause (Up to 24 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participant data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors. |
| Arm/Group Title | Enzastaurin + Sunitinib | Sunitinib + Placebo |
|---|---|---|
| Arm/Group Description | Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6-week cycle. Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42. | Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42. Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, Days 2-42. |
| Measure Participants | 0 | 0 |
| Title | Time-To-Tumor Progression in Part 2 |
|---|---|
| Description | Time to tumor progression (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. |
| Time Frame | Randomization to the Date of Objective Progressive Disease or Date of Death due to Study Disease, whichever came first (Up to 24 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participant data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors. |
| Arm/Group Title | Enzastaurin + Sunitinib | Sunitinib + Placebo |
|---|---|---|
| Arm/Group Description | Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6-week cycle. Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42. | Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42. Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, Days 2-42. |
| Measure Participants | 0 | 0 |
| Title | Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1 |
|---|---|
| Description | Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. |
| Time Frame | Randomization to Study Completion (Up to 6 Cycles) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug. |
| Arm/Group Title | Modified Regimen A (Cohort 1) | Regimen A (Cohort 2) |
|---|---|---|
| Arm/Group Description | On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. | Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. |
| Measure Participants | 11 | 6 |
| AEs |
11
100%
|
6
100%
|
| SAEs |
3
27.3%
|
1
16.7%
|
| Title | Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1 |
|---|---|
| Description | Pharmacokinetics (PK) was assessed in participants to determine the area under the concentration time curve during one dosing interval at steady state (AUCτ,ss) of Enzastaurin, LSN326020 and total Analytes. τ equals 12 hours for Enzastaurin, LSN326020 and total Analytes. |
| Time Frame | Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable PK data. |
| Arm/Group Title | Modified Regimen A (Cohort 1) | Regimen A (Cohort 2) |
|---|---|---|
| Arm/Group Description | On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. | Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. |
| Measure Participants | 11 | 5 |
| Enzastaurin |
12000
(144)
|
22600
(91)
|
| LSN326020 |
8820
(76)
|
12200
(73)
|
| Total Analytes |
21400
(101)
|
35200
(82)
|
| Title | PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1 |
|---|---|
| Description | PK was assessed in participants to determine the maximum concentration at steady state (Cmax, ss) of Enzastaurin + LSN326020 + total analytes. |
| Time Frame | Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable PK data. |
| Arm/Group Title | Modified Regimen A (Cohort 1) | Regimen A (Cohort 2) |
|---|---|---|
| Arm/Group Description | On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. | Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. |
| Measure Participants | 11 | 5 |
| Enzastaurin |
1310
(109)
|
2650
(71)
|
| LSN326020 |
816
(72)
|
1140
(64)
|
| Total Analytes |
2130
(88)
|
3740
(65)
|
Adverse Events
| Time Frame | From Baseline to Study Completion (Up to 123 Months) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All participants who received at least one dose of study drug in Part 1. | |||
| Arm/Group Title | Modified Regimen A (Cohort 1) | Regimen A (Cohort 2) | ||
| Arm/Group Description | On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle. Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. | Enzastaurin was given on Day 1 of Cycle 1 as a loading dose of 1125 mg (3 tablets of 125 mg each, taken 3 times a day with at least 4 hours between doses), followed by daily total dose of 500 mg (2 tablets of 125 mg each, BID) continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) Days 29-42. | ||
All Cause Mortality |
||||
| Modified Regimen A (Cohort 1) | Regimen A (Cohort 2) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Modified Regimen A (Cohort 1) | Regimen A (Cohort 2) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/11 (27.3%) | 1/6 (16.7%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Gastrointestinal obstruction | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| General disorders | ||||
| General physical health deterioration | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Hydrothorax | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Pulmonary embolism | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Vascular disorders | ||||
| Thrombosis | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Modified Regimen A (Cohort 1) | Regimen A (Cohort 2) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/11 (100%) | 6/6 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 8/11 (72.7%) | 33 | 4/6 (66.7%) | 10 |
| Leukopenia | 3/11 (27.3%) | 4 | 0/6 (0%) | 0 |
| Lymphopenia | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
| Neutropenia | 5/11 (45.5%) | 7 | 1/6 (16.7%) | 87 |
| Thrombocytopenia | 9/11 (81.8%) | 20 | 2/6 (33.3%) | 32 |
| Cardiac disorders | ||||
| Bradycardia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Vertigo | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Endocrine disorders | ||||
| Hyperthyroidism | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Hypothyroidism | 3/11 (27.3%) | 3 | 1/6 (16.7%) | 1 |
| Eye disorders | ||||
| Eyelid oedema | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 |
| Lacrimation increased | 2/11 (18.2%) | 5 | 0/6 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Abdominal pain | 2/11 (18.2%) | 2 | 4/6 (66.7%) | 5 |
| Abdominal pain upper | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Anal discomfort | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Anal inflammation | 3/11 (27.3%) | 3 | 1/6 (16.7%) | 1 |
| Constipation | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
| Dental discomfort | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Diarrhoea | 7/11 (63.6%) | 14 | 5/6 (83.3%) | 5 |
| Dry mouth | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Dyspepsia | 3/11 (27.3%) | 3 | 0/6 (0%) | 0 |
| Dysphagia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Flatulence | 0/11 (0%) | 0 | 1/6 (16.7%) | 2 |
| Gastrointestinal pain | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Gingivitis | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Haematochezia | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 |
| Haemorrhoids | 0/11 (0%) | 0 | 2/6 (33.3%) | 2 |
| Mouth haemorrhage | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Nausea | 4/11 (36.4%) | 7 | 2/6 (33.3%) | 3 |
| Oesophagitis | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Proctalgia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Stomatitis | 6/11 (54.5%) | 9 | 1/6 (16.7%) | 4 |
| Vomiting | 3/11 (27.3%) | 3 | 4/6 (66.7%) | 8 |
| General disorders | ||||
| Asthenia | 3/11 (27.3%) | 5 | 1/6 (16.7%) | 1 |
| Chest pain | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Chills | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 |
| Face oedema | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 5 |
| Fatigue | 5/11 (45.5%) | 5 | 3/6 (50%) | 9 |
| General physical health deterioration | 2/11 (18.2%) | 2 | 1/6 (16.7%) | 2 |
| Influenza like illness | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 |
| Malaise | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Mucosal inflammation | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Oedema | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 |
| Oedema peripheral | 4/11 (36.4%) | 7 | 1/6 (16.7%) | 1 |
| Pyrexia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Infections and infestations | ||||
| Bronchitis | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Cystitis | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Herpes zoster | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Laryngitis | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Pharyngitis | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Tooth infection | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Upper respiratory tract infection | 2/11 (18.2%) | 3 | 1/6 (16.7%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Skin laceration | 2/11 (18.2%) | 2 | 1/6 (16.7%) | 1 |
| Wound | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Investigations | ||||
| Alanine aminotransferase increased | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 13 |
| Aspartate aminotransferase increased | 0/11 (0%) | 0 | 1/6 (16.7%) | 60 |
| Blood amylase increased | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Blood bilirubin decreased | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Blood cholesterol increased | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Blood creatinine increased | 0/11 (0%) | 0 | 3/6 (50%) | 22 |
| Blood lactate dehydrogenase increased | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
| Blood sodium increased | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Blood triglycerides increased | 0/11 (0%) | 0 | 1/6 (16.7%) | 31 |
| Blood urea increased | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| C-reactive protein increased | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
| Vitamin b12 decreased | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Weight decreased | 4/11 (36.4%) | 4 | 0/6 (0%) | 0 |
| Weight increased | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Anorexia | 4/11 (36.4%) | 5 | 0/6 (0%) | 0 |
| Hypercalcaemia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Hypercholesterolaemia | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 8 |
| Hyperkalaemia | 3/11 (27.3%) | 7 | 2/6 (33.3%) | 2 |
| Hyperuricaemia | 2/11 (18.2%) | 2 | 1/6 (16.7%) | 1 |
| Hypoalbuminaemia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Hypocalcaemia | 1/11 (9.1%) | 2 | 1/6 (16.7%) | 1 |
| Hypokalaemia | 2/11 (18.2%) | 3 | 0/6 (0%) | 0 |
| Hypomagnesaemia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Hyponatraemia | 0/11 (0%) | 0 | 2/6 (33.3%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Bone pain | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Musculoskeletal chest pain | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Musculoskeletal pain | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Pain in extremity | 2/11 (18.2%) | 3 | 1/6 (16.7%) | 1 |
| Nervous system disorders | ||||
| Dysgeusia | 4/11 (36.4%) | 4 | 0/6 (0%) | 0 |
| Headache | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Hypoaesthesia | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Paraesthesia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Psychiatric disorders | ||||
| Depression | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 |
| Insomnia | 3/11 (27.3%) | 3 | 0/6 (0%) | 0 |
| Renal and urinary disorders | ||||
| Haematuria | 2/11 (18.2%) | 3 | 0/6 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Dyspnoea | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Epistaxis | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Haemoptysis | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Hydrothorax | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Nasal congestion | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Pharyngolaryngeal pain | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Rhinorrhoea | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Dry skin | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Hair colour changes | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Nail disorder | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 |
| Palmar-plantar erythrodysaesthesia syndrome | 2/11 (18.2%) | 5 | 0/6 (0%) | 0 |
| Petechiae | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Rash papular | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Skin exfoliation | 5/11 (45.5%) | 7 | 2/6 (33.3%) | 3 |
| Skin ulcer | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Urticaria localised | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
| Yellow skin | 2/11 (18.2%) | 4 | 1/6 (16.7%) | 1 |
| Vascular disorders | ||||
| Hypertension | 4/11 (36.4%) | 4 | 0/6 (0%) | 0 |
| Hypotension | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
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 |
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- H6Q-MC-S061