A Study of DKN-01 in Multiple Myeloma or Advanced Solid Tumors · Source last updated 2016-09-28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Patients
Interval / dispersion
Not reported
Time frame
Baseline to study completion (approximately 3 months)
What was measured
Number of patients who had Adverse Events (AE) including treatment related treatment emergent adverse events (TEAE), Common Toxicity Criteria for Adverse Effects (CTCAE), and Serious Adverse Events (SAE) for both Parts A and B. Severity was coded to NCI CTCAE version 4.02. For maximum severity and relationship, patients were counted only once in the most severe or most related category.
Analysis population: Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.
Groups in this outcome
75 Milligram (mg) DKN-01 Part A (QW)
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
150 mg DKN-01 Part A (QW)
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
300 mg DKN-01 Part A (QW)
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
600 mg DKN-01 Part A (Q2W)
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
300 mg DKN-01 Part B (Q2W)
Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
Total
Total across all treatment groups
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
75 Milligram (mg) DKN-01 Part A (QW)
3
150 mg DKN-01 Part A (QW)
3
300 mg DKN-01 Part A (QW)
4
600 mg DKN-01 Part A (Q2W)
3
300 mg DKN-01 Part B (Q2W)
19
Total
32
Reported measurements
At Least One AE
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
3
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
3
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
4
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
3
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
16
Not reported
Not reported
Not reported
Not reported
Total
29
Not reported
Not reported
Not reported
Not reported
At Least One TEAE
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
3
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
3
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
4
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
3
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
16
Not reported
Not reported
Not reported
Not reported
Total
29
Not reported
Not reported
Not reported
Not reported
At Least One SAE
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
2
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
7
Not reported
Not reported
Not reported
Not reported
Total
11
Not reported
Not reported
Not reported
Not reported
Retracted SAE
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
2
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
2
Not reported
Not reported
Not reported
Not reported
Total
5
Not reported
Not reported
Not reported
Not reported
SAE related to study drug
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
0
Not reported
Not reported
Not reported
Not reported
Total
0
Not reported
Not reported
Not reported
Not reported
TEAE of Maximum CTCAE - Grade 1 Mild
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
0
Not reported
Not reported
Not reported
Not reported
Total
0
Not reported
Not reported
Not reported
Not reported
TEAE of Maximum CTCAE - Grade 2 Moderate
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
2
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
3
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
6
Not reported
Not reported
Not reported
Not reported
Total
13
Not reported
Not reported
Not reported
Not reported
TEAE of Maximum CTCAE - Grade 3 Severe
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
2
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
3
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
9
Not reported
Not reported
Not reported
Not reported
Total
14
Not reported
Not reported
Not reported
Not reported
TEAE of Maximum CTCAE - Grade 4 Life Threatening
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
0
Not reported
Not reported
Not reported
Not reported
Total
1
Not reported
Not reported
Not reported
Not reported
TEAE of Maximum CTCAE - Grade 5 Death
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
1
Not reported
Not reported
Not reported
Not reported
Total
1
Not reported
Not reported
Not reported
Not reported
TEAE Grade ≥ 3 assessed as study drug related
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
0
Not reported
Not reported
Not reported
Not reported
Total
0
Not reported
Not reported
Not reported
Not reported
TEAE of Maximum Relationship - Related
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
2
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
3
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
1
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
8
Not reported
Not reported
Not reported
Not reported
Total
15
Not reported
Not reported
Not reported
Not reported
TEAE of Maximum Relationship - Not Related
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
2
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
2
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
8
Not reported
Not reported
Not reported
Not reported
Total
14
Not reported
Not reported
Not reported
Not reported
At Least One TEAE Leading to Drug Withdrawal
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
1
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
3
Not reported
Not reported
Not reported
Not reported
Total
4
Not reported
Not reported
Not reported
Not reported
At Least One TEAE Leading to Study Discontinuation
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
0
Not reported
Not reported
Not reported
Not reported
Total
0
Not reported
Not reported
Not reported
Not reported
At Least One TEAE with Outcome of Death
Values in Patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
75 Milligram (mg) DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
150 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part A (QW)
0
Not reported
Not reported
Not reported
Not reported
600 mg DKN-01 Part A (Q2W)
0
Not reported
Not reported
Not reported
Not reported
300 mg DKN-01 Part B (Q2W)
1
Not reported
Not reported
Not reported
Not reported
Total
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
3
group Id
OG004
value
16
group Id
OG005
value
29
title
At Least One AE
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
3
group Id
OG004
value
16
group Id
OG005
value
29
title
At Least One TEAE
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
7
group Id
OG005
value
11
title
At Least One SAE
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
5
title
Retracted SAE
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
SAE related to study drug
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
TEAE of Maximum CTCAE - Grade 1 Mild
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
6
group Id
OG005
value
13
title
TEAE of Maximum CTCAE - Grade 2 Moderate
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
0
group Id
OG004
value
9
group Id
OG005
value
14
title
TEAE of Maximum CTCAE - Grade 3 Severe
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
title
TEAE of Maximum CTCAE - Grade 4 Life Threatening
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
1
title
TEAE of Maximum CTCAE - Grade 5 Death
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
TEAE Grade ≥ 3 assessed as study drug related
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
1
group Id
OG004
value
8
group Id
OG005
value
15
title
TEAE of Maximum Relationship - Related
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
3
group Id
OG004
value
19
group Id
OG005
value
32
units
Participants
description
Number of patients who had Adverse Events (AE) including treatment related treatment emergent adverse events (TEAE), Common Toxicity Criteria for Adverse Effects (CTCAE), and Serious Adverse Events (SAE) for both Parts A and B. Severity was coded to NCI CTCAE version 4.02. For maximum severity and relationship, patients were counted only once in the most severe or most related category.
groups
description
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
id
OG000
title
75 Milligram (mg) DKN-01 Part A (QW)
description
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
id
OG001
title
150 mg DKN-01 Part A (QW)
description
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
id
OG002
title
300 mg DKN-01 Part A (QW)
description
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
id
OG003
title
600 mg DKN-01 Part A (Q2W)
description
Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
id
OG004
title
300 mg DKN-01 Part B (Q2W)
description
Total across all treatment groups
id
OG005
title
Total
param Type
NUMBER
population Description
Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.
reporting Status
POSTED
time Frame
Baseline to study completion (approximately 3 months)
Triangle