ID
41328
Beschrijving
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma
Trefwoorden
Versies (2)
- 25-08-20 25-08-20 -
- 17-09-21 17-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 augustus 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162
Eligibility Check
- StudyEvent: ODM
Beschrijving
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205462
- UMLS CUI [2]
- C0456369
- UMLS CUI [3,1]
- C0151779
- UMLS CUI [3,2]
- C0027627
- UMLS CUI [4]
- C1513041
Beschrijving
Regional lymph node metastasis present; Cutaneous | Regional lymph node metastasis present; subcutaneous | Distant metastasis present; Cutaneous | Distant metastasis present; subcutaneous | Disease; Operative Surgical Procedures; Cure (remedy) | AJCC tumor staging | Unresectable; Stage level 3; melanoma | In-Transit Metastasis | melanoma; Stage level 4; Metastasis stage M1a
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1275854
- UMLS CUI [1,2]
- C0221912
- UMLS CUI [2,1]
- C1275854
- UMLS CUI [2,2]
- C0443315
- UMLS CUI [3,1]
- C1275402
- UMLS CUI [3,2]
- C0221912
- UMLS CUI [4,1]
- C1275402
- UMLS CUI [4,2]
- C0443315
- UMLS CUI [5,1]
- C0012634
- UMLS CUI [5,2]
- C0543467
- UMLS CUI [5,3]
- C1880198
- UMLS CUI [6]
- C0441915
- UMLS CUI [7,1]
- C1519810
- UMLS CUI [7,2]
- C0441771
- UMLS CUI [7,3]
- C0025202
- UMLS CUI [8]
- C2985554
- UMLS CUI [9,1]
- C0025202
- UMLS CUI [9,2]
- C0441772
- UMLS CUI [9,3]
- C0445036
Beschrijving
Written informed consent obtained from the patient prior to performance of any study specific procedure.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Patient is ≥ 18 years at the time of signature of the informed consent form.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0021430
Beschrijving
The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0962473
- UMLS CUI [1,2]
- C0017262
- UMLS CUI [2]
- C0599161
- UMLS CUI [3,1]
- C1292533
- UMLS CUI [3,2]
- C2827486
- UMLS CUI [4]
- C0220908
Beschrijving
Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1292533
- UMLS CUI [1,2]
- C2827486
- UMLS CUI [2,1]
- C0221198
- UMLS CUI [2,2]
- C0445247
- UMLS CUI [3,1]
- C0962473
- UMLS CUI [3,2]
- C0017262
- UMLS CUI [4,1]
- C1708225
- UMLS CUI [4,2]
- C0681890
Beschrijving
Formalin-fixed paraffin-embedded tissue specimen; Availability of | MAGEA3 protein, human; Laboratory Procedures | Gene Signature; Laboratory Procedures | C0221198 Lesion; Same | Tissue specimen; Fresh Specimen | Lesion; second (number) | Screening procedure
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2711483
- UMLS CUI [1,2]
- C0470187
- UMLS CUI [2,1]
- C0962473
- UMLS CUI [2,2]
- C0022885
- UMLS CUI [3,1]
- C1708225
- UMLS CUI [3,2]
- C0022885
- UMLS CUI [4,1]
- C0221198
- UMLS CUI [4,2]
- C0445247
- UMLS CUI [5,1]
- C1292533
- UMLS CUI [5,2]
- C2827486
- UMLS CUI [6,1]
- C0221198
- UMLS CUI [6,2]
- C0205436
- UMLS CUI [7]
- C0220908
Beschrijving
Patient fully recovered from any previous intervention (i.e., biopsy).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1546957
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [2]
- C0005558
Beschrijving
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1520224
Beschrijving
Bone Marrow; Adequate | Renal function; Adequate | Liver function; Adequate | Laboratory; criteria; Standard (qualifier) | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum (procedure) | Bilirubin, total measurement | Lactate dehydrogenase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Upper Limit of Normal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005953
- UMLS CUI [1,2]
- C0205411
- UMLS CUI [2,1]
- C0232804
- UMLS CUI [2,2]
- C0205411
- UMLS CUI [3,1]
- C0232741
- UMLS CUI [3,2]
- C0205411
- UMLS CUI [4,1]
- C0022877
- UMLS CUI [4,2]
- C0243161
- UMLS CUI [4,3]
- C1442989
- UMLS CUI [5]
- C0948762
- UMLS CUI [6]
- C0032181
- UMLS CUI [7]
- C0201976
- UMLS CUI [8]
- C0201913
- UMLS CUI [9]
- C0202113
- UMLS CUI [10]
- C0201836
- UMLS CUI [11]
- C0201899
- UMLS CUI [12]
- C1519815
Beschrijving
When considering the enrolment of females of childbearing potential, please take note of the following definitions: • Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent). For azoospermia, “documented” refers to the laboratory report of azoospermia required for documentation of acceptable vasectomy of the patient’s male partner. • Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age e.g.,> 45 years.
Datatype
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0520483
- UMLS CUI [3]
- C0020699
- UMLS CUI [4]
- C0029936
- UMLS CUI [5]
- C0232970
- UMLS CUI [6]
- C0700589
- UMLS CUI [7]
- C0427780
Beschrijving
In the opinion of the investigator, the patient can and will comply with the protocol requirements.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0582783
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0025202
- UMLS CUI [1,2]
- C1519810
- UMLS CUI [2,1]
- C0441772
- UMLS CUI [2,2]
- C0441971
- UMLS CUI [3]
- C0558356
- UMLS CUI [4]
- C3898222
Beschrijving
cancer treatment; Systemic | Interferon | Anti-CTLA-4 Monoclonal Antibody | Therapeutic radiology procedure; Local; regional | Adjuvant therapy; Before | Dosage; Last | Cancer Vaccines | Tumor Antigens | MAGEA3 protein, human | Isolated limb perfusion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205373
- UMLS CUI [2]
- C3652465
- UMLS CUI [3]
- C4289973
- UMLS CUI [4,1]
- C1522449
- UMLS CUI [4,2]
- C0205276
- UMLS CUI [4,3]
- C0205147
- UMLS CUI [5,1]
- C0677850
- UMLS CUI [5,2]
- C0332152
- UMLS CUI [6,1]
- C0178602
- UMLS CUI [6,2]
- C1517741
- UMLS CUI [7]
- C0376659
- UMLS CUI [8]
- C0041361
- UMLS CUI [9]
- C0962473
- UMLS CUI [10]
- C0396670
Beschrijving
The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205369
- UMLS CUI [2]
- C1522449
- UMLS CUI [3,1]
- C0021083
- UMLS CUI [3,2]
- C0205394
- UMLS CUI [4]
- C3665472
- UMLS CUI [5]
- C0021081
Beschrijving
Concomitant Therapy; chronic | systemic steroids | Immunosuppressive Agents; Other | prednisone; Medication dose | topical steroids
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1707479
- UMLS CUI [1,2]
- C0205191
- UMLS CUI [2]
- C2825233
- UMLS CUI [3,1]
- C0021081
- UMLS CUI [3,2]
- C0205394
- UMLS CUI [4,1]
- C0032952
- UMLS CUI [4,2]
- C3174092
- UMLS CUI [5]
- C2064827
Beschrijving
The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004364
- UMLS CUI [2]
- C0026769
- UMLS CUI [3]
- C0409974
- UMLS CUI [4]
- C0021390
- UMLS CUI [5]
- C0042900
Beschrijving
The patient has a family history of congenital or hereditary immunodeficiency.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0853602
- UMLS CUI [2,1]
- C0021051
- UMLS CUI [2,2]
- C0439660
Beschrijving
The patient is known to be positive for Human Immunodeficiency Virus (HIV).
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019699
Beschrijving
History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0020517
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C4086268
- UMLS CUI [3]
- C1705248
- UMLS CUI [4,1]
- C0872278
- UMLS CUI [4,2]
- C0439859
Beschrijving
Comorbidity; Malignant Neoplasms | Anatomic Site; Other | Skin carcinoma | Carcinoma in situ of uterine cervix
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0006826
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3]
- C0699893
- UMLS CUI [4]
- C0851140
Beschrijving
The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004936
- UMLS CUI [2]
- C0085281
- UMLS CUI [3]
- C0021430
Beschrijving
The patient has an uncontrolled bleeding disorder.
Datatype
boolean
Alias
- UMLS CUI [1]
- C3842135
Beschrijving
The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205082
- UMLS CUI [2,1]
- C0006826
- UMLS CUI [2,2]
- C0445356
- UMLS CUI [3]
- C1321605
- UMLS CUI [4,1]
- C0035647
- UMLS CUI [4,2]
- C1883420
Beschrijving
Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013230
- UMLS CUI [2]
- C0013227
- UMLS CUI [3]
- C0042210
Beschrijving
Study Subject Participation Status; Investigational New Drugs; Pharmaceutical Preparations
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0013227
Beschrijving
For female patients: the patient is pregnant or lactating.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Similar models
Eligibility Check
- StudyEvent: ODM
C0456369 (UMLS CUI [2])
C0151779 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4])
C0221912 (UMLS CUI [1,2])
C1275854 (UMLS CUI [2,1])
C0443315 (UMLS CUI [2,2])
C1275402 (UMLS CUI [3,1])
C0221912 (UMLS CUI [3,2])
C1275402 (UMLS CUI [4,1])
C0443315 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
C1880198 (UMLS CUI [5,3])
C0441915 (UMLS CUI [6])
C1519810 (UMLS CUI [7,1])
C0441771 (UMLS CUI [7,2])
C0025202 (UMLS CUI [7,3])
C2985554 (UMLS CUI [8])
C0025202 (UMLS CUI [9,1])
C0441772 (UMLS CUI [9,2])
C0445036 (UMLS CUI [9,3])
C0021430 (UMLS CUI [2])
C0017262 (UMLS CUI [1,2])
C0599161 (UMLS CUI [2])
C1292533 (UMLS CUI [3,1])
C2827486 (UMLS CUI [3,2])
C0220908 (UMLS CUI [4])
C2827486 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0445247 (UMLS CUI [2,2])
C0962473 (UMLS CUI [3,1])
C0017262 (UMLS CUI [3,2])
C1708225 (UMLS CUI [4,1])
C0681890 (UMLS CUI [4,2])
C0470187 (UMLS CUI [1,2])
C0962473 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C1708225 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C0445247 (UMLS CUI [4,2])
C1292533 (UMLS CUI [5,1])
C2827486 (UMLS CUI [5,2])
C0221198 (UMLS CUI [6,1])
C0205436 (UMLS CUI [6,2])
C0220908 (UMLS CUI [7])
C1514463 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2])
C0205411 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
C0022877 (UMLS CUI [4,1])
C0243161 (UMLS CUI [4,2])
C1442989 (UMLS CUI [4,3])
C0948762 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0201913 (UMLS CUI [8])
C0202113 (UMLS CUI [9])
C0201836 (UMLS CUI [10])
C0201899 (UMLS CUI [11])
C1519815 (UMLS CUI [12])
C0520483 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0029936 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
C0700589 (UMLS CUI [6])
C0427780 (UMLS CUI [7])
C1519810 (UMLS CUI [1,2])
C0441772 (UMLS CUI [2,1])
C0441971 (UMLS CUI [2,2])
C0558356 (UMLS CUI [3])
C3898222 (UMLS CUI [4])
C0205373 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2])
C4289973 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
C0205147 (UMLS CUI [4,3])
C0677850 (UMLS CUI [5,1])
C0332152 (UMLS CUI [5,2])
C0178602 (UMLS CUI [6,1])
C1517741 (UMLS CUI [6,2])
C0376659 (UMLS CUI [7])
C0041361 (UMLS CUI [8])
C0962473 (UMLS CUI [9])
C0396670 (UMLS CUI [10])
C0205369 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C3665472 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
C0205191 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2])
C0021081 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0032952 (UMLS CUI [4,1])
C3174092 (UMLS CUI [4,2])
C2064827 (UMLS CUI [5])
C0026769 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C0021390 (UMLS CUI [4])
C0042900 (UMLS CUI [5])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
C1705248 (UMLS CUI [3])
C0872278 (UMLS CUI [4,1])
C0439859 (UMLS CUI [4,2])
C0006826 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0699893 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0085281 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0205082 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0445356 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3])
C0035647 (UMLS CUI [4,1])
C1883420 (UMLS CUI [4,2])
C0013227 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
C0013230 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0006147 (UMLS CUI [1,2])