NCT02196168 · STUDY IN CONTEXT

Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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

Per Response Evaluation Criteria in solid Tumors (RECIST1.1) Target lesions are assessed as Complete Response(CR), Disappearance of all target lesions; Partial Response (PR),30% decrease in the sum of the diameters of target lesions; Progressive Disease (PD), At least a 20% increase (minimum 5 mm) from smallest sum (nadir); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Nontarget lesions are assessed as Complete Response (CR), Disappearance of all non-target lesions; Non-CR/Non-PD, Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; Progressive Disease (PD),Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions; Overall Response(OR); PR=CR+non-CR/non-PD,SD=SD+non-PD; PD=PD+presence of any non-target lesions

Source null

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secondary · POSTED

Gr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug

Source null

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secondary · POSTED

Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.

No data are available as decision was made by PI not to do the analysis due to small number of patients

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secondary · POSTED

Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.

No data are available as decision was made by PI not to do the analysis due to small number of patients.

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secondary · POSTED

Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model.

Source null

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secondary · POSTED

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (20% increase in the sum of the longest diameter of target lesions or a measurable increase in a non-target lesion, or the appearance of new lesions) or death, whichever occurs first.

Source null

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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-hypopharyngeal-cancer-recurrent-58d713f9
nct id: NCT02196168
trial label: Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0000
source section id
NCT02196168-om-0000
source outcome index
0
endpoint
Overall Response Rate (Complete Plus Partial Response) Using RECIST Criteria v1.1
endpoint definition
Per Response Evaluation Criteria in solid Tumors (RECIST1.1) Target lesions are assessed as Complete Response(CR), Disappearance of all target lesions; Partial Response (PR),30% decrease in the sum of the diameters of target lesions; Progressive Disease (PD), At least a 20% increase (minimum 5 mm) from smallest sum (nadir); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Nontarget lesions are assessed as Complete Response (CR), Disappearance of all non-target lesions; Non-CR/Non-PD, Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; Progressive Disease (PD),Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions; Overall Response(OR); PR=CR+non-CR/non-PD,SD=SD+non-PD; PD=PD+presence of any non-target lesions
time origin
Up to 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0001
source section id
NCT02196168-om-0001
source outcome index
1
endpoint
Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
endpoint definition
Gr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0002
source section id
NCT02196168-om-0002
source outcome index
2
endpoint
Levels of Pharmacodynamic Biomarkers
endpoint definition
Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.
time origin
Pre-dose, at 4-8 hours on day 3 or 20-24 hours on day 4
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No data are available as decision was made by PI not to do the analysis due to small number of patients
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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0003
source section id
NCT02196168-om-0003
source outcome index
3
endpoint
Levels of Predictive Biomarkers
endpoint definition
Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.
time origin
Up to day 4 of course 1
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No data are available as decision was made by PI not to do the analysis due to small number of patients.
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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0004
source section id
NCT02196168-om-0004
source outcome index
4
endpoint
Overall Survival
endpoint definition
Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model.
time origin
12 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0005
source section id
NCT02196168-om-0005
source outcome index
5
endpoint
Progression Free Survival
endpoint definition
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (20% increase in the sum of the longest diameter of target lesions or a measurable increase in a non-target lesion, or the appearance of new lesions) or death, whichever occurs first.
time origin
Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0000
arm key
OG000
arm label
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
regimen
Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0000
arm key
OG001
arm label
Arm II (Placebo, Cisplatin)
regimen
Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0001
arm key
OG000
arm label
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
regimen
Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0001
arm key
OG001
arm label
Arm II (Placebo, Cisplatin)
regimen
Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0002
arm key
OG000
arm label
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
regimen
Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0002
arm key
OG001
arm label
Arm II (Placebo, Cisplatin)
regimen
Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0003
arm key
OG000
arm label
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
regimen
Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0003
arm key
OG001
arm label
Arm II (Placebo, Cisplatin)
regimen
Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0004
arm key
OG000
arm label
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
regimen
Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0004
arm key
OG001
arm label
Arm II (Placebo, Cisplatin)
regimen
Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0005
arm key
OG000
arm label
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
regimen
Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
outcome key
om-0005
arm key
OG001
arm label
Arm II (Placebo, Cisplatin)
regimen
Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02196168-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
harm key
EG000
source section id
NCT02196168-ae
event group key
EG000
event group label
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Source null
event definition
Source null
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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT02196168
harm key
EG001
source section id
NCT02196168-ae
event group key
EG001
event group label
Arm II (Placebo, Cisplatin)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
5
collection period
Source null
event definition
Source null
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