ID

36407

Description

Study to Assess Combination of MEDI4736 With Either AZD9150 or AZD5069 in Patients With Metastatic Squamous Cell Carcinoma of Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT02499328

Lien

https://clinicaltrials.gov/show/NCT02499328

Mots-clés

Versions (1)
  1. 12/05/2019 12/05/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

12 mai 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Metastatic Squamous Cell Carcinoma of the Head and Neck NCT02499328

Anglais

Eligibility Metastatic Squamous Cell Carcinoma of the Head and Neck NCT02499328

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients must be at least 18 years of age.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
has an eastern cooperative oncology group (ecog) ps score of 0 or 1.
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (ct) scan, except lymph nodes which must have minimum short axis size of 15 mm (ct scan slice thickness no greater than 5 mm in both cases). indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy. - part a: has a histological confirmation of a solid malignancy (other than hcc) that is refractory to standard therapy or for which no standard of care regimen currently exists. - part b:has histologically and/or cytologically confirmed scchn that is rm and not amendable to curative therapy by surgery or radiation. squamous cell carcinoma of the head and neck originating from the following sites is eligible: oral cavity, oropharynx, larynx, or hypopharynx -part b: has at least 1 scchn tumour lesion (tl) amenable to biopsy and must be medically fit and willing to undergo a biopsy during screening and, unless clinically contraindicated, at the end of cycle 1. (in the event of pd, biopsies at the end of treatment are optional but encouraged.) tumour lesions used for biopsy should not be lesions used as recist tls, unless there are no other lesions suitable for biopsy. if a recist tl is used for biopsy, the lesion must be ≥2 cm in longest diameter. -part b: must have failed, refused, or has been found to be ineligible for least 1 prior platinum-based chemotherapy for rm-scchn
Description

Measurable Disease Quantity | Lesion Dimensional Measurement Accuracy Longest Diameter | Lesion size Minimum CT scan | Exception Lymph nodes Short axis | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent | Radiofrequency ablation Absent | Exception Disease Progression | Solid Neoplasm Refractory Standard therapy | Exception Liver carcinoma | Standard therapy Unavailable | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Curative Surgery | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Curative Therapeutic radiology procedure | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Curative Surgery | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Curative Therapeutic radiology procedure | Squamous cell carcinoma of the head and neck Oral cavity | Squamous cell carcinoma of the head and neck Oropharynx | Squamous cell carcinoma of the head and neck Larynx | Squamous cell carcinoma of the head and neck Hypopharynx | Tumor Lesion Amenable Biopsy | Chemotherapy Platinum-Based failed | Chemotherapy Platinum-Based Refused | Ineligibility Chemotherapy Platinum-Based | Recurrent Head and Neck Squamous Cell Carcinoma | HEAD NECK CANCER SQUAMOUS CELL METASTATIC

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C3494215
UMLS CUI [2,3]
C0552406
UMLS CUI [3,1]
C0449453
UMLS CUI [3,2]
C1524031
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0024204
UMLS CUI [4,3]
C0522488
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0850292
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0242656
UMLS CUI [9,1]
C0280100
UMLS CUI [9,2]
C0205269
UMLS CUI [9,3]
C2936643
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C2239176
UMLS CUI [11,1]
C2936643
UMLS CUI [11,2]
C0686905
UMLS CUI [12,1]
C4524839
UMLS CUI [12,2]
C1548788
UMLS CUI [12,3]
C1273390
UMLS CUI [12,4]
C0543467
UMLS CUI [13,1]
C4524839
UMLS CUI [13,2]
C1548788
UMLS CUI [13,3]
C1273390
UMLS CUI [13,4]
C1522449
UMLS CUI [14,1]
C0744620
UMLS CUI [14,2]
C1548788
UMLS CUI [14,3]
C1273390
UMLS CUI [14,4]
C0543467
UMLS CUI [15,1]
C0744620
UMLS CUI [15,2]
C1548788
UMLS CUI [15,3]
C1273390
UMLS CUI [15,4]
C1522449
UMLS CUI [16,1]
C1168401
UMLS CUI [16,2]
C0226896
UMLS CUI [17,1]
C1168401
UMLS CUI [17,2]
C0521367
UMLS CUI [18,1]
C1168401
UMLS CUI [18,2]
C0023078
UMLS CUI [19,1]
C1168401
UMLS CUI [19,2]
C0020629
UMLS CUI [20,1]
C0027651
UMLS CUI [20,2]
C0221198
UMLS CUI [20,3]
C3900053
UMLS CUI [20,4]
C0005558
UMLS CUI [21,1]
C0392920
UMLS CUI [21,2]
C1514162
UMLS CUI [21,3]
C0231175
UMLS CUI [22,1]
C0392920
UMLS CUI [22,2]
C1514162
UMLS CUI [22,3]
C1705116
UMLS CUI [23,1]
C1512714
UMLS CUI [23,2]
C0392920
UMLS CUI [23,3]
C1514162
UMLS CUI [24]
C4524839
UMLS CUI [25]
C0744620
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment. - presently has a second malignancy other than scchn, or history of treatment for invasive cancer other than scchn in the past 3 years. exceptions are
Description

Compression of spinal cord | Exception Compression of spinal cord Asymptomatic | Exception Requirement Absent Steroids | Second Cancer | Exception Squamous cell carcinoma of the head and neck | Therapy Invasive cancer | Exception Squamous cell carcinoma of the head and neck

Type de données

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0037926
UMLS CUI [2,3]
C0231221
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0332197
UMLS CUI [3,4]
C0038317
UMLS CUI [4]
C0751623
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1168401
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0677898
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1168401
previously treated in-situ carcinoma (ie, noninvasive)
Description

Exception Carcinoma in Situ Treated | Exception Carcinoma in Situ Noninvasive

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0007099
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007099
UMLS CUI [2,3]
C2986496
cervical carcinoma stage 1b or less
Description

Exception Cervix carcinoma TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0302592
UMLS CUI [1,3]
C3258246
noninvasive basal cell and squamous cell skin carcinoma radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy
Description

Exception Basal cell carcinoma Noninvasive | Exception Squamous cell carcinoma of skin Noninvasive | Exception Radical therapy Prostate carcinoma | Prostatectomy | Therapeutic radiology procedure | Exception Prostate specific antigen normal | Exception Requirement Absent Antiandrogen therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0007117
UMLS CUI [1,3]
C2986496
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0553723
UMLS CUI [2,3]
C2986496
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0260176
UMLS CUI [3,3]
C0600139
UMLS CUI [4]
C0033573
UMLS CUI [5]
C1522449
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0580554
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0332197
UMLS CUI [7,4]
C0279492
patients must have completed any previous cancer-related treatments before enrolment. any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable). - part a: 1.patients with clinically active brain metastases (known or suspected) are excluded unless the brain metastases have been previously treated and are considered stable. stable brain metastases are defined as no change on ct scan or magnetic resonance imaging (mri) scan for a minimum of 2 months and no change in steroid dose for a minimum of 4 weeks, unless change due to intercurrent infection or other acute event. - part b: patients with brain metastases
Description

Requirement Cancer treatment Completed | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Biological treatment | Hormone Therapy | Insulin Acceptable Diabetes Mellitus | Hormone replacement therapy Acceptable | Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected | Exception Metastatic malignant neoplasm to brain Treated | Exception Metastatic malignant neoplasm to brain Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0021083
UMLS CUI [5]
C1531518
UMLS CUI [6]
C0279025
UMLS CUI [7,1]
C0021641
UMLS CUI [7,2]
C1879533
UMLS CUI [7,3]
C0011849
UMLS CUI [8,1]
C0282402
UMLS CUI [8,2]
C1879533
UMLS CUI [9]
C0220650
UMLS CUI [10,1]
C0220650
UMLS CUI [10,2]
C0750491
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0220650
UMLS CUI [11,3]
C1522326
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0220650
UMLS CUI [12,3]
C0205360
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Similar models

Eligibility Metastatic Squamous Cell Carcinoma of the Head and Neck NCT02499328

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female patients must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
has an eastern cooperative oncology group (ecog) ps score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Measurable Disease Quantity | Lesion Dimensional Measurement Accuracy Longest Diameter | Lesion size Minimum CT scan | Exception Lymph nodes Short axis | Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent | Radiofrequency ablation Absent | Exception Disease Progression | Solid Neoplasm Refractory Standard therapy | Exception Liver carcinoma | Standard therapy Unavailable | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Curative Surgery | Recurrent Head and Neck Squamous Cell Carcinoma Inappropriate Curative Therapeutic radiology procedure | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Curative Surgery | HEAD NECK CANCER SQUAMOUS CELL METASTATIC Inappropriate Curative Therapeutic radiology procedure | Squamous cell carcinoma of the head and neck Oral cavity | Squamous cell carcinoma of the head and neck Oropharynx | Squamous cell carcinoma of the head and neck Larynx | Squamous cell carcinoma of the head and neck Hypopharynx | Tumor Lesion Amenable Biopsy | Chemotherapy Platinum-Based failed | Chemotherapy Platinum-Based Refused | Ineligibility Chemotherapy Platinum-Based | Recurrent Head and Neck Squamous Cell Carcinoma | HEAD NECK CANCER SQUAMOUS CELL METASTATIC
Item
has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (ct) scan, except lymph nodes which must have minimum short axis size of 15 mm (ct scan slice thickness no greater than 5 mm in both cases). indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy. - part a: has a histological confirmation of a solid malignancy (other than hcc) that is refractory to standard therapy or for which no standard of care regimen currently exists. - part b:has histologically and/or cytologically confirmed scchn that is rm and not amendable to curative therapy by surgery or radiation. squamous cell carcinoma of the head and neck originating from the following sites is eligible: oral cavity, oropharynx, larynx, or hypopharynx -part b: has at least 1 scchn tumour lesion (tl) amenable to biopsy and must be medically fit and willing to undergo a biopsy during screening and, unless clinically contraindicated, at the end of cycle 1. (in the event of pd, biopsies at the end of treatment are optional but encouraged.) tumour lesions used for biopsy should not be lesions used as recist tls, unless there are no other lesions suitable for biopsy. if a recist tl is used for biopsy, the lesion must be ≥2 cm in longest diameter. -part b: must have failed, refused, or has been found to be ineligible for least 1 prior platinum-based chemotherapy for rm-scchn
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C3494215 (UMLS CUI [2,2])
C0552406 (UMLS CUI [2,3])
C0449453 (UMLS CUI [3,1])
C1524031 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0024204 (UMLS CUI [4,2])
C0522488 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0850292 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0242656 (UMLS CUI [8,2])
C0280100 (UMLS CUI [9,1])
C0205269 (UMLS CUI [9,2])
C2936643 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C2239176 (UMLS CUI [10,2])
C2936643 (UMLS CUI [11,1])
C0686905 (UMLS CUI [11,2])
C4524839 (UMLS CUI [12,1])
C1548788 (UMLS CUI [12,2])
C1273390 (UMLS CUI [12,3])
C0543467 (UMLS CUI [12,4])
C4524839 (UMLS CUI [13,1])
C1548788 (UMLS CUI [13,2])
C1273390 (UMLS CUI [13,3])
C1522449 (UMLS CUI [13,4])
C0744620 (UMLS CUI [14,1])
C1548788 (UMLS CUI [14,2])
C1273390 (UMLS CUI [14,3])
C0543467 (UMLS CUI [14,4])
C0744620 (UMLS CUI [15,1])
C1548788 (UMLS CUI [15,2])
C1273390 (UMLS CUI [15,3])
C1522449 (UMLS CUI [15,4])
C1168401 (UMLS CUI [16,1])
C0226896 (UMLS CUI [16,2])
C1168401 (UMLS CUI [17,1])
C0521367 (UMLS CUI [17,2])
C1168401 (UMLS CUI [18,1])
C0023078 (UMLS CUI [18,2])
C1168401 (UMLS CUI [19,1])
C0020629 (UMLS CUI [19,2])
C0027651 (UMLS CUI [20,1])
C0221198 (UMLS CUI [20,2])
C3900053 (UMLS CUI [20,3])
C0005558 (UMLS CUI [20,4])
C0392920 (UMLS CUI [21,1])
C1514162 (UMLS CUI [21,2])
C0231175 (UMLS CUI [21,3])
C0392920 (UMLS CUI [22,1])
C1514162 (UMLS CUI [22,2])
C1705116 (UMLS CUI [22,3])
C1512714 (UMLS CUI [23,1])
C0392920 (UMLS CUI [23,2])
C1514162 (UMLS CUI [23,3])
C4524839 (UMLS CUI [24])
C0744620 (UMLS CUI [25])
Item Group
C0680251 (UMLS CUI)
Compression of spinal cord | Exception Compression of spinal cord Asymptomatic | Exception Requirement Absent Steroids | Second Cancer | Exception Squamous cell carcinoma of the head and neck | Therapy Invasive cancer | Exception Squamous cell carcinoma of the head and neck
Item
has a spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment. - presently has a second malignancy other than scchn, or history of treatment for invasive cancer other than scchn in the past 3 years. exceptions are
boolean
C0037926 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0037926 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0038317 (UMLS CUI [3,4])
C0751623 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C1168401 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0677898 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C1168401 (UMLS CUI [7,2])
Exception Carcinoma in Situ Treated | Exception Carcinoma in Situ Noninvasive
Item
previously treated in-situ carcinoma (ie, noninvasive)
boolean
C1705847 (UMLS CUI [1,1])
C0007099 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
C2986496 (UMLS CUI [2,3])
Exception Cervix carcinoma TNM clinical staging
Item
cervical carcinoma stage 1b or less
boolean
C1705847 (UMLS CUI [1,1])
C0302592 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Exception Basal cell carcinoma Noninvasive | Exception Squamous cell carcinoma of skin Noninvasive | Exception Radical therapy Prostate carcinoma | Prostatectomy | Therapeutic radiology procedure | Exception Prostate specific antigen normal | Exception Requirement Absent Antiandrogen therapy
Item
noninvasive basal cell and squamous cell skin carcinoma radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy
boolean
C1705847 (UMLS CUI [1,1])
C0007117 (UMLS CUI [1,2])
C2986496 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0553723 (UMLS CUI [2,2])
C2986496 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0260176 (UMLS CUI [3,2])
C0600139 (UMLS CUI [3,3])
C0033573 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0580554 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C0279492 (UMLS CUI [7,4])
Requirement Cancer treatment Completed | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Biological treatment | Hormone Therapy | Insulin Acceptable Diabetes Mellitus | Hormone replacement therapy Acceptable | Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected | Exception Metastatic malignant neoplasm to brain Treated | Exception Metastatic malignant neoplasm to brain Stable
Item
patients must have completed any previous cancer-related treatments before enrolment. any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable). - part a: 1.patients with clinically active brain metastases (known or suspected) are excluded unless the brain metastases have been previously treated and are considered stable. stable brain metastases are defined as no change on ct scan or magnetic resonance imaging (mri) scan for a minimum of 2 months and no change in steroid dose for a minimum of 4 weeks, unless change due to intercurrent infection or other acute event. - part b: patients with brain metastases
boolean
C1514873 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C0279025 (UMLS CUI [6])
C0021641 (UMLS CUI [7,1])
C1879533 (UMLS CUI [7,2])
C0011849 (UMLS CUI [7,3])
C0282402 (UMLS CUI [8,1])
C1879533 (UMLS CUI [8,2])
C0220650 (UMLS CUI [9])
C0220650 (UMLS CUI [10,1])
C0750491 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0220650 (UMLS CUI [11,2])
C1522326 (UMLS CUI [11,3])
C1705847 (UMLS CUI [12,1])
C0220650 (UMLS CUI [12,2])
C0205360 (UMLS CUI [12,3])
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