Trial Outcomes & Findings for Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT NCT02196168)
NCT ID: NCT02196168
Last Updated: 2017-05-03
Results Overview
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
TERMINATED
PHASE2
6 participants
Up to 1 year
2017-05-03
Participant Flow
Participant milestones
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
|
Overall Study
COMPLETED
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
n=6 Participants
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
|
Arm II (Placebo, Cisplatin)
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
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
—
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
—
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
—
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPer 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
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
n=6 Participants
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Overall Response Rate (Complete Plus Partial Response) Using RECIST Criteria v1.1
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearGr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
n=6 Participants
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
|
13 adverse events
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, at 4-8 hours on day 3 or 20-24 hours on day 4Population: No data are available as decision was made by PI not to do the analysis due to small number of patients
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.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Levels of Pharmacodynamic Biomarkers
|
0
|
0
|
SECONDARY outcome
Timeframe: Up to day 4 of course 1Population: No data are available as decision was made by PI not to do the analysis due to small number of patients.
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.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Levels of Predictive Biomarkers
|
0
|
0
|
SECONDARY outcome
Timeframe: 12 monthsEstimated 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.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
n=6 Participants
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Overall Survival
|
0.21 months
Interval 0.01 to 0.6
|
—
|
SECONDARY outcome
Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 monthsProgression-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.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
n=6 Participants
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Progression Free Survival
|
2.88 months
Interval 0.99 to
The upper limit for Measure of Dispersion was 'not reached' for this study
|
—
|
SECONDARY outcome
Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed at 12 monthsEstimated 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.
Outcome measures
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
n=6 Participants
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Progression Free Survival
|
2.88 months
Interval 0.99 to
The upper limit for Measure of Dispersion was 'not reached' for this study
|
—
|
Adverse Events
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
Arm II (Placebo, Cisplatin)
Serious adverse events
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
n=6 participants at risk
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
16.7%
1/6
|
—
0/0
|
|
Investigations
lymphocyte count decreased
|
16.7%
1/6
|
—
0/0
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6
|
—
0/0
|
|
Investigations
white blood cell decreased
|
33.3%
2/6
|
—
0/0
|
|
Investigations
neutrophil count decreased
|
33.3%
2/6
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle weakness
|
33.3%
2/6
|
—
0/0
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6
|
—
0/0
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
16.7%
1/6
|
—
0/0
|
Other adverse events
| Measure |
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
n=6 participants at risk
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
|
Arm II (Placebo, Cisplatin)
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6
|
—
0/0
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6
|
—
0/0
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6
|
—
0/0
|
|
Investigations
white blood cell decreased
|
33.3%
2/6
|
—
0/0
|
|
Investigations
hypophosphatemia
|
33.3%
2/6
|
—
0/0
|
|
Metabolism and nutrition disorders
alkalosis
|
16.7%
1/6
|
—
0/0
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6
|
—
0/0
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6
|
—
0/0
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
16.7%
1/6
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle weakness
|
16.7%
1/6
|
—
0/0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6
|
—
0/0
|
|
Infections and infestations
Lung infection
|
16.7%
1/6
|
—
0/0
|
|
Investigations
Platelet count decreased
|
16.7%
1/6
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60