ID
44275
Descripción
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma
Palabras clave
Versiones (2)
- 24/2/19 24/2/19 -
- 20/9/21 20/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de septiembre de 2021
DOI
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Licencia
Creative Commons BY-NC 3.0
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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556
Screening - Demography; Inclusion Criteria; Exclusion Criteria
- StudyEvent: ODM
Descripción
Demography
Alias
- UMLS CUI-1
- C0011298
Descripción
Date informed consent signed
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Descripción
Subject Initials
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Check one box only
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0079399
Descripción
Race
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0034510
Descripción
If other race, please specify.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C0021430
Descripción
2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0026764
- UMLS CUI [2]
- C0162643
Descripción
3. The subject has measurable disease.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1513041
Descripción
4. The subject has relapsed or relapsed/refractory disease
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C0205269
Descripción
5. The subject has a life expectancy of greater than 6 months.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0023671
Descripción
6. The subject has an ECOG Performance status of 0 to 2.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1520224
Descripción
7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0019196
Descripción
8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C2826293
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C0205161
- UMLS CUI [2,3]
- C2826293
Descripción
9. The subject has the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0565998
- UMLS CUI [2,1]
- C2700391
- UMLS CUI [2,2]
- C1507394
Descripción
10. The subject must be able to adhere to the study visit schedule and other protocol requirements.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C1321605
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C1512346
- UMLS CUI [1,5]
- C0086960
- UMLS CUI [1,6]
- C1709747
Descripción
11. The subject must understand and voluntarily sign an informed consent document.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0021430
Descripción
12. If the subject is of reproductive potential, the subject must agree prior to study entry to use ad equate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C4034483
- UMLS CUI [1,2]
- C0700589
Descripción
13. The subject must have Adequate end organ function
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0678852
- UMLS CUI [2]
- C0201913
- UMLS CUI [3]
- C0201836
- UMLS CUI [4]
- C0201899
- UMLS CUI [5]
- C0201976
- UMLS CUI [6]
- C0948762
- UMLS CUI [7]
- C0005821
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
1. Intolerance to resveratrol, SRT501, bortezomib, Boron, Mannitol or prior toxicity
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0073096
- UMLS CUI [2,1]
- C1744706
- UMLS CUI [2,2]
- C2002402
- UMLS CUI [3,1]
- C1744706
- UMLS CUI [3,2]
- C1176309
- UMLS CUI [4,1]
- C1744706
- UMLS CUI [4,2]
- C0006030
- UMLS CUI [5,1]
- C1744706
- UMLS CUI [5,2]
- C0024730
- UMLS CUI [6]
- C0013221
Descripción
2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0007117
- UMLS CUI [1,4]
- C0553723
Descripción
3. The subject has an uncontrolled intercurrent illness including, but not limited to, recent (≤ 6 months), ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute diffuse infiltrative pulmonary or pericardial disease, or psychiatric illness/social situations that would limit compliance with study requirements.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205318
- UMLS CUI [2]
- C0009450
- UMLS CUI [3]
- C0018802
- UMLS CUI [4]
- C0002965
- UMLS CUI [5]
- C0003811
- UMLS CUI [6]
- C1735346
- UMLS CUI [7]
- C0265122
- UMLS CUI [8]
- C0004936
Descripción
4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0017178
- UMLS CUI [1,2]
- C4054723
- UMLS CUI [1,3]
- C0678745
Descripción
5. Breast Feeding | Pregnancy | Sex Behavior | Contraceptive methods; Appropriate | Serum pregnancy test negative; Serum Beta-HCG Test | Postmenopausal state | Female Sterilization
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0006147
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0036864
- UMLS CUI [4,1]
- C0700589
- UMLS CUI [4,2]
- C1548787
- UMLS CUI [5,1]
- C0430061
- UMLS CUI [5,2]
- C1255526
- UMLS CUI [6]
- C0232970
- UMLS CUI [7]
- C0015787
Descripción
6. The subject has had chemotherapy or radiotherapy within 4 weeks prior to signing Informed Consent or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0392920
- UMLS CUI [2]
- C1522449
- UMLS CUI [3]
- C0021430
- UMLS CUI [4]
- C0877248
Descripción
7. The subject is on concurrent medications that may exhibit anti-neoplastic therapy, with the exception of ≤10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C2827774
- UMLS CUI [2]
- C0032952
- UMLS CUI [3]
- C0020268
- UMLS CUI [4]
- C0456388
Descripción
8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0242295
- UMLS CUI [2]
- C0949266
- UMLS CUI [3]
- C0073096
Descripción
9. The subject has peripheral neuropathy of Grade 2 or greater.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0031117
Descripción
10. The subject has uncontrolled bleeding.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0019080
Descripción
11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2748540
- UMLS CUI [2]
- C1390214
- UMLS CUI [3]
- C0005821
Descripción
12. The subject has a hemoglobin level less than < 8.0 g/dL. Transfusions and/or EPO treatment are permitted in subjects who are potentially excluded by this criteria.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0019046
- UMLS CUI [2]
- C1879316
- UMLS CUI [3]
- C0014822
Descripción
13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1853129
Similar models
Screening - Demography; Inclusion Criteria; Exclusion Criteria
- StudyEvent: ODM
C0009797 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0162643 (UMLS CUI [2])
C0205269 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0205307 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0430456 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
C2700391 (UMLS CUI [2,1])
C1507394 (UMLS CUI [2,2])
C1321605 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1512346 (UMLS CUI [1,4])
C0086960 (UMLS CUI [1,5])
C1709747 (UMLS CUI [1,6])
C0700589 (UMLS CUI [1,2])
C0201913 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0005821 (UMLS CUI [7])
C0073096 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2002402 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1176309 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0006030 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0024730 (UMLS CUI [5,2])
C0013221 (UMLS CUI [6])
C1705847 (UMLS CUI [1,2])
C0007117 (UMLS CUI [1,3])
C0553723 (UMLS CUI [1,4])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C1735346 (UMLS CUI [6])
C0265122 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C4054723 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0036864 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C1548787 (UMLS CUI [4,2])
C0430061 (UMLS CUI [5,1])
C1255526 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6])
C0015787 (UMLS CUI [7])
C1522449 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0877248 (UMLS CUI [4])
C2827774 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2])
C0020268 (UMLS CUI [3])
C0456388 (UMLS CUI [4])
C0949266 (UMLS CUI [2])
C0073096 (UMLS CUI [3])
C1390214 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C1879316 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
C1853129 (UMLS CUI [2])