A Study of DKN-01 in Multiple Myeloma or Advanced Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.

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.

→

primary · POSTED

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.

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.

→

secondary · POSTED

Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.

All patients who received at least one dose of study treatment during Part A or Part B of the study.

→

secondary · POSTED

Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.

All patients who received at least one dose of study treatment during Part A study.

→

secondary · POSTED

Peak DKN-01 serum concentration (Cmax) after the first and fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.

All patients who received at least one dose of study treatment during Part A or Part B of the study.

→

secondary · POSTED

Peak DKN-01 serum concentration (Cmax) after the fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.

All patients who received at least one dose of study treatment during Part A of the study.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id: NCT01457417
trial label: A Study of DKN-01 in Multiple Myeloma or Advanced Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0000
source section id
NCT01457417-om-0000
source outcome index
0
endpoint
Summary of Total Adverse Events (AE)
endpoint definition
Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.
time origin
Baseline to study completion (approximately 3 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0001
source section id
NCT01457417-om-0001
source outcome index
1
endpoint
Summary of Patients With Adverse Events (AE)
endpoint definition
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.
time origin
Baseline to study completion (approximately 3 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0002
source section id
NCT01457417-om-0002
source outcome index
2
endpoint
Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01
endpoint definition
Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.
time origin
Cycle 1 Day 1 (first dose, all groups)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients who received at least one dose of study treatment during Part A or Part B of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0003
source section id
NCT01457417-om-0003
source outcome index
3
endpoint
Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01
endpoint definition
Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.
time origin
Cycle 1 Day 22 (Fourth Dose for QW)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients who received at least one dose of study treatment during Part A study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0004
source section id
NCT01457417-om-0004
source outcome index
4
endpoint
Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01
endpoint definition
Peak DKN-01 serum concentration (Cmax) after the first and fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.
time origin
Cycle 1 Day 1 (first dose, all groups)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients who received at least one dose of study treatment during Part A or Part B of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0005
source section id
NCT01457417-om-0005
source outcome index
5
endpoint
Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01
endpoint definition
Peak DKN-01 serum concentration (Cmax) after the fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.
time origin
Cycle 1 Day 22 (Fourth dose for QW groups)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients who received at least one dose of study treatment during Part A of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0000
arm key
OG000
arm label
75 Milligram (mg) DKN-01 Part A (QW)
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0000
arm key
OG001
arm label
150 mg DKN-01 Part A (QW)
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0000
arm key
OG002
arm label
300 mg DKN-01 Part A (QW)
regimen
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.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0000
arm key
OG003
arm label
600 mg DKN-01 Part A (Q2W)
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0000
arm key
OG004
arm label
300 mg DKN-01 Part B (Q2W)
regimen
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.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0000
arm key
OG005
arm label
Total
regimen
Total across all treatment groups
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0001
arm key
OG000
arm label
75 Milligram (mg) DKN-01 Part A (QW)
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0001
arm key
OG001
arm label
150 mg DKN-01 Part A (QW)
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0001
arm key
OG002
arm label
300 mg DKN-01 Part A (QW)
regimen
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.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0001
arm key
OG003
arm label
600 mg DKN-01 Part A (Q2W)
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0001
arm key
OG004
arm label
300 mg DKN-01 Part B (Q2W)
regimen
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.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
outcome key
om-0001
arm key
OG005
arm label
Total
regimen
Total across all treatment groups
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01457417-om-0001#groups/OG005

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
harm key
EG000
source section id
NCT01457417-ae
event group key
EG000
event group label
75 Milligram (mg) DKN-01 Part A
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Entirety of the study. 1 year, 3 months.
event definition
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. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
harm key
EG001
source section id
NCT01457417-ae
event group key
EG001
event group label
150 mg DKN-01 Part A
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Entirety of the study. 1 year, 3 months.
event definition
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. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
harm key
EG002
source section id
NCT01457417-ae
event group key
EG002
event group label
300 mg DKN-01 Part A
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Entirety of the study. 1 year, 3 months.
event definition
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. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
harm key
EG003
source section id
NCT01457417-ae
event group key
EG003
event group label
600 mg DKN-01 Part A
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Entirety of the study. 1 year, 3 months.
event definition
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. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-stage-iv-recurrent-064adc80
nct id
NCT01457417
harm key
EG004
source section id
NCT01457417-ae
event group key
EG004
event group label
300 mg DKN-01 Part B
serious affected
6
serious at risk
19
other affected
16
other at risk
19
frequency threshold
0
collection period
Entirety of the study. 1 year, 3 months.
event definition
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. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice