TriangleNCT02196168 · 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: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
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
Gr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug
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.
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.
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.
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.
Reported safety
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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
- 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