ID
42779
Beschreibung
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
Stichworte
Versionen (2)
- 25.08.20 25.08.20 -
- 17.09.21 17.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
17. September 2021
DOI
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Lizenz
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
Beschreibung
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205462
- UMLS CUI [2]
- C0456369
- UMLS CUI [3,1]
- C0151779
- UMLS CUI [3,2]
- C0027627
- UMLS CUI [4]
- C1513041
Beschreibung
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
Datentyp
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
Beschreibung
Written informed consent obtained from the patient prior to performance of any study specific procedure.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Patient is ≥ 18 years at the time of signature of the informed consent form.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0021430
Beschreibung
The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
Datentyp
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
Beschreibung
Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature
Datentyp
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
Beschreibung
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
Datentyp
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
Beschreibung
Patient fully recovered from any previous intervention (i.e., biopsy).
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2826210
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [2]
- C0005558
Beschreibung
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1520224
Beschreibung
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
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
In the opinion of the investigator, the patient can and will comply with the protocol requirements.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0582783
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
Datentyp
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
Beschreibung
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
Datentyp
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
Beschreibung
The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
Datentyp
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
Beschreibung
Concomitant Therapy; chronic | systemic steroids | Immunosuppressive Agents; Other | prednisone; Medication dose | topical steroids
Datentyp
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
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004364
- UMLS CUI [2]
- C0026769
- UMLS CUI [3]
- C0409974
- UMLS CUI [4]
- C0021390
- UMLS CUI [5]
- C0042900
Beschreibung
The patient has a family history of congenital or hereditary immunodeficiency.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0853602
- UMLS CUI [2,1]
- C0021051
- UMLS CUI [2,2]
- C0439660
Beschreibung
The patient is known to be positive for Human Immunodeficiency Virus (HIV).
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019699
Beschreibung
History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.
Datentyp
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
Beschreibung
Comorbidity; Malignant Neoplasms | Anatomic Site; Other | Skin carcinoma | Carcinoma in situ of uterine cervix
Datentyp
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
Beschreibung
The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004936
- UMLS CUI [2]
- C0085281
- UMLS CUI [3]
- C0021430
Beschreibung
The patient has an uncontrolled bleeding disorder.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3842135
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013230
- UMLS CUI [2]
- C0013227
- UMLS CUI [3]
- C0042210
Beschreibung
Study Subject Participation Status; Investigational New Drugs; Pharmaceutical Preparations
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0013227
Beschreibung
For female patients: the patient is pregnant or lactating.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Ähnliche Modelle
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])