Trial Outcomes & Findings for A Study of LY2584702 in Solid Tumors (NCT NCT01241461)
NCT ID: NCT01241461
Last Updated: 2018-08-21
Results Overview
A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count \<50.0 x 10\^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count \<0.5 x 10\^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Baseline through 30 days
Results posted on
2018-08-21
Participant Flow
Participant milestones
| Measure |
50 mg LY2584702
50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
75 mg LY2584702
75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
50 mg LY2584702
50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
75 mg LY2584702
75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
|---|---|---|
|
Overall Study
Progressive Disease
|
3
|
6
|
Baseline Characteristics
A Study of LY2584702 in Solid Tumors
Baseline characteristics by cohort
| Measure |
50 mg LY2584702
n=3 Participants
50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
75 mg LY2584702
n=6 Participants
75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.44 years
STANDARD_DEVIATION 7.17 • n=39 Participants
|
64.07 years
STANDARD_DEVIATION 4.15 • n=41 Participants
|
64.86 years
STANDARD_DEVIATION 5.00 • n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Japan
|
3 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Pathological Diagnosis
Adenocarcinoma, Colon
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Pathological Diagnosis
Adenocarcinoma, Esophageal
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Pathological Diagnosis
Adenocarcinoma, Gastric
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Pathological Diagnosis
Carcinoid Tumor, not otherwise specified (NOS)
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Pathological Diagnosis
Carcinoma, Esophagus
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Pathological Diagnosis
Gastrointestinal Stromal Tumors
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status Prior to Cycle 1
0 - Fully active
|
2 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status Prior to Cycle 1
1 - Ambulatory, restricted strenuous activity
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline through 30 daysPopulation: All participants who were enrolled in the study.
A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count \<50.0 x 10\^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count \<0.5 x 10\^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity.
Outcome measures
| Measure |
50 mg LY2584702
n=3 Participants
50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
75 mg LY2584702
n=6 Participants
75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
50 mg LY2584702 Multiple Doses
50 mg LY2584702 oral doses twice daily for a 28-day cycle
|
75 mg LY2584702 Multiple Doses
75 mg LY2584702 oral doses twice daily for a 28-day cycle
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to study completion up to Day 183Population: All participants who were enrolled in the study.
Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is ≥30% decrease in sum of longest diameter of target lesions.
Outcome measures
| Measure |
50 mg LY2584702
n=3 Participants
50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
75 mg LY2584702
n=6 Participants
75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
50 mg LY2584702 Multiple Doses
50 mg LY2584702 oral doses twice daily for a 28-day cycle
|
75 mg LY2584702 Multiple Doses
75 mg LY2584702 oral doses twice daily for a 28-day cycle
|
|---|---|---|---|---|
|
Number of Participants With Tumor Response
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: PredosePopulation: All participants who were enrolled in the study.
AUC of single dose is AUC(0-12hours), and AUC of multiple doses is AUC during one dosing interval at steady state.
Outcome measures
| Measure |
50 mg LY2584702
n=3 Participants
50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
75 mg LY2584702
n=6 Participants
75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
50 mg LY2584702 Multiple Doses
n=3 Participants
50 mg LY2584702 oral doses twice daily for a 28-day cycle
|
75 mg LY2584702 Multiple Doses
n=6 Participants
75 mg LY2584702 oral doses twice daily for a 28-day cycle
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2584702
|
5100 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 58
|
4990 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54
|
8020 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 66
|
10300 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: PredosePopulation: All participants who were enrolled in the study.
Outcome measures
| Measure |
50 mg LY2584702
n=3 Participants
50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
75 mg LY2584702
n=6 Participants
75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
50 mg LY2584702 Multiple Doses
n=3 Participants
50 mg LY2584702 oral doses twice daily for a 28-day cycle
|
75 mg LY2584702 Multiple Doses
n=6 Participants
75 mg LY2584702 oral doses twice daily for a 28-day cycle
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2584702
|
805 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
732 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
1140 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 78
|
1400 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
Adverse Events
50 mg LY2584702
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
75 mg LY2584702
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50 mg LY2584702
n=3 participants at risk
50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
75 mg LY2584702
n=6 participants at risk
75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 5
|
66.7%
4/6 • Number of events 4
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Malaise
|
66.7%
2/3 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
|
Investigations
Blood alkaline phosphatase increased
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60